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Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168062
Recruitment Status : Terminated (Funding)
First Posted : June 20, 2014
Results First Posted : June 1, 2020
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Prostate Adenocarcinoma
Interventions Behavioral: Behavioral Dietary Intervention
Other: Counseling
Other: Educational Intervention
Behavioral: Exercise Intervention
Drug: Goserelin Acetate
Other: Laboratory Biomarker Analysis
Drug: Leuprolide Acetate
Other: Quality-of-Life Assessment
Drug: Triptorelin Pamoate
Enrollment 57
Recruitment Details  
Pre-assignment Details This study included a small, non-randomized pilot cohort of 8 patients receiving concurrent chemohormonal therapy who were enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population but were not included in the final group comparisons.
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic) Non-Randomized Pilot Cohort
Hide Arm/Group Description

Patients receive leuprolide acetate subcutaneous (SC) or intramuscular (IM), or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

A non-randomized pilot cohort receiving concurrent chemohormonal therapy will be enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population.
Period Title: Overall Study
Started 23 26 8
Completed 23 26 8
Not Completed 0 0 0
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic) Non-Randomized Pilot Cohort Total
Hide Arm/Group Description

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

A non-randomized pilot cohort of 20 patients receiving concurrent chemohormonal therapy will be enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population. Total of all reporting groups
Overall Number of Baseline Participants 23 26 8 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 26 participants 8 participants 57 participants
50-60 years old 4 7 3 14
61-70 years old 9 11 4 24
71-80 years old 8 7 1 16
81-90 years old 1 1 0 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 26 participants 8 participants 57 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
23
 100.0%
26
 100.0%
8
 100.0%
57
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 26 participants 8 participants 57 participants
Hispanic or Latino
0
   0.0%
1
   3.8%
2
  25.0%
3
   5.3%
Not Hispanic or Latino
20
  87.0%
22
  84.6%
6
  75.0%
48
  84.2%
Unknown or Not Reported
3
  13.0%
3
  11.5%
0
   0.0%
6
  10.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 26 participants 8 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
  21.7%
0
   0.0%
0
   0.0%
5
   8.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   3.8%
0
   0.0%
1
   1.8%
Black or African American
3
  13.0%
1
   3.8%
2
  25.0%
6
  10.5%
White
13
  56.5%
21
  80.8%
4
  50.0%
38
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   8.7%
3
  11.5%
2
  25.0%
7
  12.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 26 participants 8 participants 57 participants
23 26 8 57
1.Primary Outcome
Title Absolute Change in Percentage Body Fat Mass as Measured by Bioelectrical Impedance Analyzer (Randomized Cohort)
Hide Description The absolute change from baseline in percentage body fat after 12 months of study participation for participants in the randomized cohort was measured using a bioelectrical impedance analyzer and between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: percentage of body fat mass
-1
(-28.5 to 11.6)
6.8
(-20.2 to 17.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants in the Non-randomized, Pilot, Cohort Who Completed Clinic Visits
Hide Description The percentage of participants in the pilot, non-randomized cohort who completed clinic visits for Supportive Therapy in Androgen Deprivation (STAND) will be reported to assess feasibility.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Randomized Pilot Cohort
Hide Arm/Group Description:
A non-randomized pilot cohort receiving concurrent chemohormonal therapy will be enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
62.5
3.Secondary Outcome
Title Absolute Change in Blood Pressure (Randomized Cohort)
Hide Description Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in systolic and diastolic blood pressure from the baseline to month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: mmHg
Systolic Blood Pressure
10
(-11 to 46)
9
(-25 to 27)
Diastolic Blood Pressure
2
(-10 to 37)
-3
(-16 to 13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Systolic Blood Pressure measurement comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Diastolic Blood Pressure measurement comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Absolute Change in Body Weight (Randomized Cohort)
Hide Description Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in body weight from the baseline to month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: kilograms
0.8
(-8.4 to 15)
2.6
(-11.3 to 16.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Weight measurement comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Absolute Change in Percentage of Body Fat (Randomized Cohort)
Hide Description Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in percentage of body fat from the baseline to the month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: percentage of body fat
-1
(-28.5 to 11.6)
6.8
(-20.2 to 17.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Percentage body fat measurement comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Absolute Change in Waist Circumference (Randomized Cohort)
Hide Description Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in waist circumference from the baseline to the month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: centimeters
5
(-8 to 14)
1.7
(-4 to 9.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Waist measurement comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Absolute Change in Hemoglobin A1c (Randomized Cohort)
Hide Description Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in percentage hemoglobin A1c from the baseline to the month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: percentage
-0.1
(-0.8 to 0.7)
-0.1
(-0.8 to 0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Hemoglobin A1C measurement comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Absolute Change in Insulin Resistance Score (Randomized Cohort)
Hide Description Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in insulin resistance scores from the baseline to the month 12 assessment. Insulin resistance scores were calculated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). This calculation marks for both the presence and extent of any insulin resistance that participants might currently express. The HOMA-IR is an assessment using insulin and glucose lab values to generate an insulin resistance score. A healthy score range is 1.0 (0.5-1.4). A score of less than 1.0 means you are insulin-sensitive which is optimal. A score above 1.9 indicates early insulin resistance. A score above 2.9 indicates significant insulin resistance. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: score on a scale
0
(-1.5 to 5.4)
-0.5
(-3.1 to 3.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Insulin resistance score comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Absolute Change in Fasting Lipids (Randomized Cohort)
Hide Description Metabolic and cardiac impact for participants in the randomized cohort was measured by calculating the absolute change in fasting lipids which includes total cholesterol, low density lipoprotein, High density lipoprotein, and triglycerides levels from the baseline to the month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: milligram per deciliter (mg/dL)
Total Cholesterol
4
(-313 to 134)
-1
(-102 to 138)
Low density lipoprotein
-4
(-26 to 86)
-4
(-64 to 50)
High density lipoprotein
5
(-18 to 46)
7
(-70.4 to 21)
Triglycerides
19
(-79 to 188)
-3
(-135 to 182)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Total Cholesterol measurement comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Total low density lipid measurement comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Total high density lipid measurement comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Total triglyceride measurement comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Absolute Change in Hours Per Week of Physical Activity Category as Measured by the Exercise Pattern Assessment (Randomized Cohort)
Hide Description Metabolic impact for participants from baseline to 12 months was measured using an exercise pattern questionnaire. The questionnaire measured self-reported average total time per week over the past year the participant participated in various physical activities such as walking, tennis, yoga, swimming, etc. Twelve response options for each activity are as follows: None, 1-4 minutes (min), 5-19 min, 20-39 min, 40-89 min, 1.5 hours, 2-3 hours, 4-6 hours, 7-10 hours, 11-20 hours, 21-30 hours, 31-40 hours, 40+ hours. The amount of time per week spent on each activity was converted to a hourly scale and the absolute change between baseline and month 12 times were calculated for each participant. The median absolute change in hours per week were compared for each of the 6 activity categories: non-vigorous, moderate, moderate-vigorous, vigorous, and total physical activity and total moderate and vigorous activity combined.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only a small subset of patients reported both baseline and 12 month data.
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 15 12
Median (Full Range)
Unit of Measure: hours per week
Non-vigorous physical activity
-0.62
(-10.00 to 6.54)
-1.03
(-7.30 to 2.30)
Moderate physical activity
0.00
(-7.00 to 7.00)
0.00
(-8.50 to 2.50)
Vigorous physical activity
-0.20
(-26.22 to 37.46)
-0.02
(-5.00 to 2.96)
Total physical activity
-.30
(-19.68 to 39.26)
-.90
(-6.58 to 2.30)
Total Moderate-Vigorous physical activity (MVPA)
-0.30
(-19.22 to 39.46)
-0.08
(-5.54 to 2.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Non-vigorous physical activity comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Moderate physical activity comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.979
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Moderate-Vigorous physical activity comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.884
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Vigorous physical activity comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.678
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Total physical activity comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.464
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Absolute Change in Average Moderate to Vigorous Physical Activity (MVPA) as Measured by an Ambulatory Accelerometer Assessment (Randomized Cohort)
Hide Description Metabolic impact for participants in each group from baseline to 12 months was measured by using an ambulatory accelerometer worn by participants around their waist for 7 consecutive days. Participants were required at least 3 days of valid wear time, defined as >= 10 hours of wear per day. The accelerometer measured movement intensity and recorded vertical acceleration as "counts," providing an indication of the intensity of physical activity associated with locomotion. Non-wear time was identified using Troiano 2007 default settings in the ActiLife v6.13.3 software. The amount of time participants were engaged in moderate to vigorous physical activities (MVPA) was measured by accelerometer as counts per minute (moderate activity = 2020-5998 counts per minute, and vigorous activity = 5999 or more counts per minute). Counts are then transformed into minutes per day with a total range of 0-1440 minutes. The median absolute change in average MVPA was compared between the two groups.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only a small subset of patients reported both baseline and 12 month data.
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 3 8
Median (Full Range)
Unit of Measure: minutes per day
-18.40
(-45.46 to 39.50)
-2.36
(-26.30 to 5.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Average MVPA Minutes per Day Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.838
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Absolute Change in Bone Density T-score (Randomized Cohort)
Hide Description The absolute change in bone density t-scores from the baseline to the month 12 assessment for participants in the randomized cohort was measured using bone density at the lumbar spine, bone density at the femoral neck, and bone density at the total hip. A T-score of -1.0 or above is normal bone density. A T-score between -1.0 and -2.5 indicates low bone density or osteopenia. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: t-score
Bone density at the lumbar spine
-2.0
(-3.50 to 0.10)
-0.40
(-1.80 to 0.60)
Bone density at the femoral neck
-0.25
(-2.30 to 1.90)
-0.20
(-2.10 to 1.20)
Bone density of total hip
-0.20
(-2.30 to 0.10)
-0.10
(-0.70 to 0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Bone Density at the lumbar spine comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.677
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Bone Density at the femoral neck comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.493
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Bone Density of the total hip comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.807
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Absolute Change in Serum 25-(OH) Vitamin D (Randomized Cohort)
Hide Description The absolute change in bone health parameters as measured by the serum 25-(OH) vitamin D level from the baseline to the month 12 assessment. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: nanograms per milliliter (ng/mL)
3.60
(-14 to 24)
8.10
(-21 to 20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Serum 25-(OH) vitamin D level comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.403
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Absolute Change in Patient Health Questionnaire-9 (PHQ-9) Scores (Randomized Cohort)
Hide Description

The absolute change in scores on the Patient Health Questionnaire-9 (PHQ-9) from baseline after 12 months of study participation for participants was used to measure depression symptoms with a higher number indicating a greater percentage of change in scores. The total Patient Health Questionnaire-9 (PHQ-9) score is calculated by combining the responses of the participant on questions addressing how bothered the participant has been by various problems over the past 2 weeks. Each of the 9 items is scored on a scale of 0 ("Not bothered at all") to 4 ("Nearly every day"). A total score of 5-9='Mild Depression Symptoms", 10-4="Minor Depression, Major Depression (mild), or Dysthymia", 15-19="Major Depression, moderately severe", and >20="Major Depression".

Between group comparisons were performed using the Wilcoxon-rank-sum test.

Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: score on a scale
0
(-5.0 to 3.00)
.50
(-5.0 to 3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .385
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
15.Secondary Outcome
Title Absolute Change in Attention Function Index (AFI) Scores (Randomized Cohort)
Hide Description The AFI measures a participants perceived effectiveness in functioning at time of assessment. Each of the 16 items consists of a 100 mm horizontal line anchored with opposite phrases from not at all (0 mm) to extremely well or a great deal (100 mm). Subjects are asked to place a mark on the line that best describes functioning in relation to specific activity. Scores for each item are determined by measuring distance from lower end of scale in millimeters. The total score on the instrument is computed by obtaining an average of 16 scales. The absolute change in score by group from baseline up to month 12 in Attention Function Index was used to measure perceived effectiveness in common activities requiring attention and working memory in daily life with a higher number indicating a greater absolute change in scores. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only a subset of patients reported both baseline and 12 month data.
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 15 11
Median (Full Range)
Unit of Measure: score on a scale
2.31
(-27.75 to 26.62)
-4
(-15.26 to 10.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Attention Function Index (AFI) Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .148
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Secondary Outcome
Title Absolute Change in the 12-item Short Form Survey (SF-12) Assessment Item Scores for Patients in the Randomized Cohort
Hide Description The SF-12 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. The SF-12 consists of a subset of 12 items from the SF-36® Health Survey (SF-36) and measures two composite outcomes assessing mental health composite score (MCS) and physical health composite scores (PCS). The PCS & MCS are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The absolute change in item score by group from baseline up to 12 months was used to assess the quality of life/psychosocial impact on the patients with a larger scores indicating a greater degree of change on physical and mental health. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only a subset of participants completed questionnaires at both baseline and 12 months.
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Overall Number of Participants Analyzed 20 25
Median (Full Range)
Unit of Measure: score on a scale
Mental Composite Score
4.81
(-8.46 to 11.90)
-2.37
(-7.37 to 4.03)
Physical Composite Score
-2.90
(-17.82 to 18.75)
-1.60
(-6.65 to 8.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Mental Composite Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .077
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Physical Composite Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Secondary Outcome
Title Absolute Change in International Prostate Symptom Score (IPSS) (Randomized Cohort)
Hide Description The absolute change in score by group from baseline up to month 12 on the International Prostate Symptom Score (IPSS) was used to measure the severity of lower urinary tract symptoms and erectile function with lower numbers indicating less change in symptoms. Seven questions with scores ranging from 1-5 are summed to create a total score. Scores of 1-7 indicate mild symptoms, scores of 8-19 indicate moderate symptoms, and scores of 20-35 indicate severe symptoms. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: score on a scale
2
(-20 to 24)
-2
(-9 to 22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
18.Secondary Outcome
Title Absolute Change in Last Question on International Prostate Symptom Score (IPSS) (Randomized Cohort)
Hide Description The absolute change in score by group from baseline up to month 12 on the International Prostate Symptom Score (IPSS) was used to measure the severity of lower urinary tract symptoms and erectile function. The last question on the IPSS can be looked at separately from the total score as it asks the participants to rate the overall quality of life due to their existing urinary symptoms on a scale of 0-6, with lower scores indicating a better quality of life. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: score on a scale
0
(-3 to 2)
0
(-1 to 1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
19.Secondary Outcome
Title Absolute Change in Hot Flash Related Daily Interference Scale Score (HFRDIS) (Randomized Cohort)
Hide Description The absolute change in Hot Flash Related Daily Interference Scale from baseline to month 12 was used to measure the impact of occurrence of hot flashes on daily activities with higher numbers indicating a greater change in the interference of hot flashes with participant's quality of life. The HFRDIS is a 10-item scale measuring the degree hot flashes interfere with nine daily activities; the tenth item measures the degree hot flashes interfere with overall quality of life. The HFRDIS was developed to include daily life activities specific to impact of hot flashes. Participants rate degree to which hot flashes have interfered with each item during previous week using a 0 (do not interfere) to 10 (completely interfere) point scale, with total score ranging from 0-100. Higher scores indicate higher interference and thus, greater impact on quality of life. Women without hot flashes are asked to mark 0 for each item. Group comparisons performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: score on a scale
13
(-22 to 67)
4.5
(-52 to 37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Secondary Outcome
Title Absolute Change in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scores to Assess Erectile and Urinary Function (Randomized Cohort)
Hide Description The EPIC-26 was measured at baseline and month 12 to determine the impact of quality of life issues across 5 prostate cancer specific domains: Urinary incontinence, Urinary irritation, Bowel function, Sexual function, and Hormonal function and overall total quality of life. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL). Between group comparisons were performed using the Wilcoxon-rank-sum test
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only a subset of patients reported both baseline and 12 month data.
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC, and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Patients receive leuprolide acetate SC or IM, or goserelin acetate SC every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietitian, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 25 20
Median (Full Range)
Unit of Measure: score on a scale
Total
-4.91
(-25.53 to 17.10)
-3.85
(-11.54 to 11.27)
Urinary incontinence
0
(-37.75 to 39.50)
0
(-20.57 to 17.00)
Urinary irritation
-5.00
(-27.50 to 60.00)
5.00
(-5.00 to 25.00)
Bowel function
0
(-87.50 to 25.00)
-4.17
(-16.67 to 12.50)
Sexual function
-12.50
(-47.00 to 16.67)
-2.08
(-48.67 to 12.50)
Hormonal Function
0
(-41.25 to 12.50)
-17.50
(-35.00 to 25.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments EPIC-26 Total Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments EPIC-26 Urinary Incontinence Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.844
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments EPIC-26 Urinary Irriation Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments EPIC-26 Bowel Function Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.472
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments EPIC-26 Sexual Function Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.405
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments EPIC-26 Hormonal Function Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.749
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
21.Secondary Outcome
Title Absolute Change in Lee Fatigue Scale Scores (Randomized Cohort)
Hide Description The absolute change in Lee Fatigue Scale from baseline to month 12 was used to measure the impact of Fatigue on a participants quality of life. The scale consists of 18 items relating to the subjective experience of fatigue. Each item asks respondents to place an "X" representing how they currently feel, along a visual analogue line that extends between two extremes (e.g., from "not at all tired" to "extremely tired"). Each line is 100 mm in length - thus, scores fall between 0 and 100. The instrument also possesses two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10). The fatigue subscale score is calculated as the mean of the 13 fatigue items, and the energy subscale score is the mean of the 5 energy items. Higher scores on the fatigue subscale represent greater fatigue severity, and higher scores on the energy subscale indicate higher levels of energy. Between group comparisons were performed using the Wilcoxon-rank-sum test.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic)
Hide Arm/Group Description:

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Overall Number of Participants Analyzed 23 26
Median (Full Range)
Unit of Measure: score on a scale
Fatigue Scale
5.68
(-36.09 to 33.38)
3.15
(-5.40 to 29.15)
Energy Scale
-0.10
(-19.80 to 44.20)
1.30
(-15.60 to 27.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Fatigue Scale Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.907
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Standard of Care), Arm II (STAND Clinic)
Comments Energy Scale Score Comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.792
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Up to 12 months
Adverse Event Reporting Description The Behavioral-Dietary intervention under investigation was not determined to pose any significant risk to the patient however, all grade(s) 3-5 adverse events, whether or not unexpected, and whether or not considered to be associated with the use of the study treatment were collected.
 
Arm/Group Title Arm I (Standard of Care) Arm II (STAND Clinic) Non-Randomized Pilot Cohort
Hide Arm/Group Description

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM and visit their health care provider every 3 months for 12 months. Patients will be referred to a nutrition, exercise, and symptom management service upon patient request or if deemed necessary by a healthcare provider. Patients may cross-over to Arm II after 12 months.

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

Patients receive leuprolide acetate SC or IM, goserelin acetate SC, or triptorelin pamoate IM every 3 months for 12 months. Patients also review educational modules discussing various aspects of anti-androgen therapy and management of side effects and meet one-to-one with a licensed exercise trainer, registered dietician, and symptom management service to receive individualized counseling monthly for 12 months.

Behavioral Dietary Intervention: Receive individualized nutrition counseling

Counseling: Receive individualized symptom management service counseling

Educational Intervention: Review educational modules

Exercise Intervention: Receive individualized exercise counseling

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given SC or IM

Quality-of-Life Assessment: Ancillary studies

Triptorelin Pamoate: Given IM

A non-randomized pilot cohort receiving concurrent chemohormonal therapy will be enrolled in parallel to assess the feasibility of STAND clinic participation in this patient population.
All-Cause Mortality
Arm I (Standard of Care) Arm II (STAND Clinic) Non-Randomized Pilot Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/26 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Arm I (Standard of Care) Arm II (STAND Clinic) Non-Randomized Pilot Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/26 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Standard of Care) Arm II (STAND Clinic) Non-Randomized Pilot Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/26 (0.00%)   0/8 (0.00%) 
Absolute change calculated for outcomes and and non-parametric statistical tests performed due to small sample size from early study termination. Non-randomized pilot cohort to assess feasibility was not included in group comparisons.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Li Zhang, PhD
Organization: University of California, San Francisco
Phone: (415) 476-5339
EMail: Li.Zhang@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02168062    
Other Study ID Numbers: 135513
NCI-2015-01058 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: May 15, 2014
First Posted: June 20, 2014
Results First Submitted: November 20, 2019
Results First Posted: June 1, 2020
Last Update Posted: July 23, 2020