We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiation Therapy in Treating 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: NCT01434290
Recruitment Status : Completed
First Posted : September 14, 2011
Results First Posted : November 17, 2017
Last Update Posted : June 9, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity
Sexual Dysfunction
Interventions Radiation: 36.25 Gy IMRT
Radiation: 51.6 Gy IMRT
Enrollment 255
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description 36.25 Gy IMRT (intensity modulated radiation therapy) in 5 fractions over two and a half weeks 51.6 Gy IMRT in 12 fractions over two and a half weeks
Period Title: Overall Study
Started 127 128
Completed 119 [1] 121 [1]
Not Completed 8 7
Reason Not Completed
Protocol Violation             6             3
No protocol treatment             2             4
[1]
Eligible subjects included in analysis
Arm/Group Title 5 Fractions 12 Fractions Total
Hide Arm/Group Description 36.25 Gy IMRT in 5 fractions over two and a half weeks 51.6 Gy IMRT in 12 fractions over two and a half weeks Total of all reporting groups
Overall Number of Baseline Participants 119 121 240
Hide Baseline Analysis Population Description
Eligible patients who started protocol treatment
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 119 participants 121 participants 240 participants
64
(48 to 77)
66
(50 to 79)
65
(48 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 121 participants 240 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
119
 100.0%
121
 100.0%
240
 100.0%
1.Primary Outcome
Title Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points
Hide Description The co-primary endpoint is the percentage of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) bowel domain score from baseline to 1 year that exceeds 5 points (baseline - one year > 5). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.
Time Frame Baseline and one year from the end of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment and completed the bowel domain of the EPIC at baseline and one year
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 93 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30.1
(20.8 to 39.4)
28.0
(19.2 to 36.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 Fractions
Comments ≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel & urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method One sample z-test
Comments One-sided 0.025 significance level
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 Fractions
Comments ≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel & urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method One sample z-test
Comments one-sided 0.025 significance level
2.Primary Outcome
Title The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points
Hide Description The co-primary endpoint is the proportion of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) urinary domain score from baseline to 1 year that exceeds 2 points (baseline - one year > 2). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.
Time Frame Baseline and one year from the end of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment and completed the urinary domain of the EPIC at baseline and one year
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 93 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45.2
(35.4 to 55.0)
42.0
(32.3 to 51.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 Fractions
Comments ≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel & urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method One sample z-test
Comments One-sided 0.025 significance level
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 Fractions
Comments ≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel & urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method One sample z-test
Comments One-sided 0.025 significance level
3.Secondary Outcome
Title Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm
Hide Description Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. An acute adverse event is defined as the first occurrence of worst severity of the adverse event ≤30 days after the completion of radiation therapy (RT). The high dose RT arm of Radiation Therapy Oncology Group (RTOG) study RTOG-0126 (NCT00033631) reported 1% of patients experienced grade 3+ GI/GU acute toxicity with no patient experiencing a grade 4 or 5 toxicity. If the lower confidence interval is >1%, then that arm will be further investigated for acceptability. A late adverse event is defined as the first occurrence of worst severity of adverse event >30 days after RT completion. Arms are not compared to each other.
Time Frame Start of protocol treatment to one year from the end of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 119 121
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Acute
1.7
(0.2 to 5.9)
1.7
(0.2 to 5.9)
Late
0.8
(0.1 to 4.2)
0.8
(0.1 to 4.2)
4.Secondary Outcome
Title Rate of PSA Failure
Hide Description Failure occurs when the PSA is first noted to be 2 ng/mL or more than the current nadir value (PSA > current nadir + 2) post RT completion. Time to PSA failure is defined as time from registration to the date of PSA failure, last known follow-up (censored), or death without PSA failure (competing risk). Rate of PSA failure is estimated by the cumulative incidence method. The protocol specified that one-, two-, and five-year rates would be reported. Arms are not compared to each other.
Time Frame Registration to five years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment and were at risk at the given time point
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 119 121
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
One year Number Analyzed 119 participants 121 participants
0.0 [1] 
(NA to NA)
0.8
(0.1 to 4.1)
Two years Number Analyzed 118 participants 115 participants
0.0 [1] 
(NA to NA)
0.8
(0.1 to 4.1)
Five years Number Analyzed 93 participants 97 participants
3.4
(1.1 to 8.0)
3.5
(1.1 to 8.0)
[1]
Insufficient number of participants with events
5.Secondary Outcome
Title Rate of Disease-free Survival (DFS)
Hide Description Disease-free survival duration is time from the date of randomization to the date of documentation of disease progression or until the date of death from any cause (censored). DFS is estimated by the Kaplan-Meier method. The protocol specified that one-, two-, and five-year rates would be reported. Arms are not compared to each other.
Time Frame Registration to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment and were at risk at the given time point
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 119 121
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
One year Number Analyzed 118 participants 120 participants
99.2
(97.5 to 100.0)
99.2
(97.6 to 100.0)
Two years Number Analyzed 118 participants 115 participants
99.2
(97.5 to 100.0)
97.5
(94.7 to 100.0)
Five years Number Analyzed 92 participants 97 participants
89.6
(84.0 to 95.2)
92.3
(87.4 to 97.1)
6.Secondary Outcome
Title Mean Quality Adjusted Life Years at 5 Years
Hide Description Quality-adjusted survival time combines disease-free survival time and quality of life as measured by the EuroQol 5-dimensional (EQ-5D) index score. It is calculated for each patient as the weighted sum of different time episodes and added up to total quality-adjusted life years . The EQ-5D measures health-related quality of life and consists of two parts, a general health visual analog scale and 5 general health questions. The latter questions are transformed into a single index score ranging from 0 (worst health state) to 1 (best health state). Arms are not compared to each other.
Time Frame Registration to 5 years from the end of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment with baseline EQ-5D and at least 1 follow-up assessment (EQ-5D Index Score)
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 90 85
Mean (Standard Deviation)
Unit of Measure: quality-adjusted life years
6.13  (10.55) 4.87  (1.14)
7.Secondary Outcome
Title Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year
Hide Description The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life and a positive change from baseline indicating improvement over time. For this endpoint, in each domain, the actual change score calculated as timepoint score - baseline score will be used as the statistic.
Time Frame Baseline and one year from the end of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started protocol treatment and completed the respective domain of the EPIC at baseline and one year
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 93 100
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1-year Bowel
1.79
(-26.79 to 53.57)
0
(-26.79 to 46.42)
1-year Urinary
0
(-25.75 to 69.42)
0
(-47.92 to 63.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 Fractions
Comments [Bowel one-year results] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Two-sided significance level of 0.017.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 Fractions
Comments [Bowel one-year results] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Two-sided significance level of 0.017.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 5 Fractions
Comments [Urinary one-year results] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Two-sided significance level of 0.017
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 12 Fractions
Comments [Urinary one-year results] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Two-side significance level of 0.017
8.Secondary Outcome
Title The Percentage of Patients With Reduction From Baseline at One Year in EPIC Sexual Domain Score That Exceeds 11 Points
Hide Description The percentage of patients with a reduction in the EPIC sexual domain score from baseline that exceeds 11 points (baseline - one year > 11). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.
Time Frame Baseline one year from the end of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and completed the specified domain of the EPIC at baseline and one year
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 88 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32.9
(23.1 to 42.7)
30.4
(21.0 to 39.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 Fractions
Comments ≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method One-sample z-test
Comments One-sided 0.025 significance level
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 Fractions
Comments ≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method One sample z-test
Comments One-side significance level of 0.025
9.Secondary Outcome
Title The Percentage of Patients With Reduction From Baseline at One Year in EPIC Hormonal Domain Score That Exceeds 3 Points
Hide Description The percentage of patients with a reduction in the EPIC hormonal domain score from baseline that exceeds 3 points (baseline - one year > 3). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.
Time Frame Baseline and one year from the end of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and completed the specified domain of the EPIC at baseline and one year
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 90 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
36.7
(26.7 to 46.7)
38.1
(28.4 to 47.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 Fractions
Comments ≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method one sampe z-test
Comments One-sided significance level of 0.025
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 Fractions
Comments ≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method One sample z-test
Comments One-sided significance level of 0.025
10.Secondary Outcome
Title Change From Baseline in EQ-5D Scores
Hide Description The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score. One, 2, and 5 years will be entered when they are available. Arms are not compared.
Time Frame Baseline and one year from the end of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment and completed the EQ-5D at baseline and the specified timepoint
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 66 67
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1-year Index Score Number Analyzed 66 participants 67 participants
0
(-0.554 to 0.200)
0
(-0.447 to 0.603)
1-year VAS Number Analyzed 65 participants 63 participants
0
(-30 to 74)
0
(-60 to 89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 Fractions
Comments [One-year Index Score] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Two-sided significance level of 0.017.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 12 Fractions
Comments [One-year Index Score] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Two-sided significance level of 0.017.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 5 Fractions
Comments [One-year VAS Score] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Two-sided significance level of 0.017.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 12 Fractions
Comments [One-year VAS Score] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Two-sided significance level of 0.017.
11.Secondary Outcome
Title Utilization of Sexual Medications/Devices Questionnaire Response Frequences
Hide Description The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The number of subjects responding "Yes" to the following questions are reported: "Do you have a penile prosthesis", "Have you used an medications or devices to aid or improve erections?". Arms are not compared to each other. One, 2, and 5 years will be entered when they are available.
Time Frame Baseline and one year from the end of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and completed the questionnaire at baseline and the specified timepoint
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Unit of Measure: participants
Baseline penile prosthesis question Number Analyzed 94 participants 96 participants
6 7
Baseline medications/devices question Number Analyzed 91 participants 94 participants
30 29
1-year penile prosthesis question Number Analyzed 81 participants 82 participants
2 5
1-year Baseline medications/devices question Number Analyzed 79 participants 78 participants
25 29
12.Secondary Outcome
Title Genetic Markers Associated With Normal Tissue Toxicities Resulting From Radiotherapy
Hide Description [Not Specified]
Time Frame Study entry to 5 years from the end of protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The biomarker data will not be obtained due to lack of funding therefore no patients have outcome measure data.
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description:
36.25 Gy IMRT (intensity modulated radiation therapy) in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. Eligible patients with adverse event data are included.
 
Arm/Group Title 5 Fractions 12 Fractions
Hide Arm/Group Description 36.25 Gy IMRT in 5 fractions over two and a half weeks 51.6 Gy IMRT in 12 fractions over two and a half weeks
All-Cause Mortality
5 Fractions 12 Fractions
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
5 Fractions 12 Fractions
Affected / at Risk (%) Affected / at Risk (%)
Total   1/119 (0.84%)   0/121 (0.00%) 
Gastrointestinal disorders     
Anal hemorrhage * 1  1/119 (0.84%)  0/121 (0.00%) 
Reproductive system and breast disorders     
Ejaculation disorder * 1  1/119 (0.84%)  0/121 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5 Fractions 12 Fractions
Affected / at Risk (%) Affected / at Risk (%)
Total   101/119 (84.87%)   106/121 (87.60%) 
Gastrointestinal disorders     
Constipation * 1  10/119 (8.40%)  5/121 (4.13%) 
Diarrhea * 1  28/119 (23.53%)  31/121 (25.62%) 
Fecal incontinence * 1  8/119 (6.72%)  6/121 (4.96%) 
Gastrointestinal disorders - Other * 1  15/119 (12.61%)  15/121 (12.40%) 
Hemorrhoids * 1  9/119 (7.56%)  8/121 (6.61%) 
Proctitis * 1  18/119 (15.13%)  21/121 (17.36%) 
Rectal hemorrhage * 1  13/119 (10.92%)  5/121 (4.13%) 
Rectal pain * 1  6/119 (5.04%)  2/121 (1.65%) 
General disorders     
Fatigue * 1  30/119 (25.21%)  34/121 (28.10%) 
Psychiatric disorders     
Libido decreased * 1  10/119 (8.40%)  6/121 (4.96%) 
Renal and urinary disorders     
Cystitis noninfective * 1  17/119 (14.29%)  20/121 (16.53%) 
Hematuria * 1  9/119 (7.56%)  11/121 (9.09%) 
Renal and urinary disorders - Other * 1  33/119 (27.73%)  35/121 (28.93%) 
Urinary frequency * 1  66/119 (55.46%)  70/121 (57.85%) 
Urinary incontinence * 1  16/119 (13.45%)  22/121 (18.18%) 
Urinary retention * 1  22/119 (18.49%)  26/121 (21.49%) 
Urinary tract obstruction * 1  10/119 (8.40%)  6/121 (4.96%) 
Urinary tract pain * 1  13/119 (10.92%)  21/121 (17.36%) 
Urinary urgency * 1  39/119 (32.77%)  47/121 (38.84%) 
Reproductive system and breast disorders     
Ejaculation disorder * 1  11/119 (9.24%)  12/121 (9.92%) 
Erectile dysfunction * 1  51/119 (42.86%)  44/121 (36.36%) 
Reproductive system and breast disorders - Other * 1  6/119 (5.04%)  6/121 (4.96%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01434290    
Other Study ID Numbers: RTOG 0938
CDR0000703580
NCI-2011-03629 ( Registry Identifier: CTRP (Clinical Trials Reporting Program) )
First Submitted: September 13, 2011
First Posted: September 14, 2011
Results First Submitted: August 24, 2017
Results First Posted: November 17, 2017
Last Update Posted: June 9, 2022