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Trial record 25 of 1544 for:    Androgens

Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer (AADLPC)

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: NCT02175212
Recruitment Status : Active, not recruiting
First Posted : June 26, 2014
Results First Posted : November 4, 2016
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Adenocarcinoma
Interventions Drug: Short term androgen deprivation
Drug: Long term androgen deprivation
Radiation: Short term androgen deprivation
Radiation: Long term androgen deprivation
Enrollment 362
Recruitment Details Between Nov 7, 2005, and Dec 20, 2010, 362 were registered. Of these, seven did not meet the inclusion criteria. The final trial population thus consisted of 355 men, of whom 178 were randomly assigned to the short-term androgen deprivation group and 177 to the long-term androgen deprivation group.
Pre-assignment Details  
Arm/Group Title Long Term Androgen Deprivation Short Term Androgen Deprivation
Hide Arm/Group Description
  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

  • Bicalutamide 50 mg tablet every day for 2 months
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy

Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

- Bicalutamide 50 mg tablet every day for 2 months

Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

Period Title: Overall Study
Started 177 178
Completed 14 31
Not Completed 163 147
Arm/Group Title Long Term Androgen Deprivation Short Term Androgen Deprivation Total
Hide Arm/Group Description
  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

  • Bicalutamide 50 mg tablet every day for 2 months
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy

Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

- Bicalutamide 50 mg tablet every day for 2 months

Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

Total of all reporting groups
Overall Number of Baseline Participants 177 178 355
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 177 participants 178 participants 355 participants
71
(56 to 82)
72
(54 to 85)
71
(54 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 177 participants 178 participants 355 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
177
 100.0%
178
 100.0%
355
 100.0%
Risk subgroup (intermediate vs. high)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 178 participants 355 participants
Intermediate 85 81 166
High 92 97 189
T stage (categorical)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 178 participants 355 participants
T1: tumor neither palpable not visible by imaging 38 42 80
T2: Tumor confinent whitin prostate 100 103 203
T3: Tumor extends through the prostate capsule 39 33 72
[1]
Measure Description: Patients were staged according to the AJCC Cancer Staging criteria, 6th edition. Intermediate-risk and high-risk factors were defined following the 2005 guidelines of the National Comprehensive Cancer Network.
PSA (continous)  
Median (Full Range)
Unit of measure:  Nanogrames per milliliter (ng/mL)
Number Analyzed 177 participants 178 participants 355 participants
11.1
(3.1 to 72.0)
11.0
(3.4 to 66.0)
11
(3.1 to 72.0)
PSA (categorical)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 178 participants 355 participants
<10 ng/mL 80 74 154
10-20 ng/mL 61 64 125
>20 ng/mL 36 40 76
Gleason score (categorical)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 178 participants 355 participants
<=6 21 30 51
7 110 103 213
8-10 46 45 91
[1]
Measure Description: Gleason classification for prostate cancer were used considering Gleason 6 as less aggressive and Gleason 10 most aggressive
Positive biopsy samples (continous)  
Median (Full Range)
Unit of measure:  Number of cylindres
Number Analyzed 177 participants 178 participants 355 participants
4
(1 to 13)
4
(1 to 16)
4
(1 to 16)
Prostate radiotherapy dose (continous)  
Median (Full Range)
Unit of measure:  Grays (Gy)
Number Analyzed 177 participants 178 participants 355 participants
78.0
(30.6 to 88.4)
78.0
(64.0 to 82.2)
78.0
(30.6 to 88.4)
Prostate radiotherapy dose (categorical)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 178 participants 355 participants
<78 Gy 43 51 94
>= 78 Gy 128 122 250
[1]
Measure Description: 173 evaluable patients in short term group and 171 in the long term group
Pelvic radiotherapy (categorical)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 177 participants 178 participants 355 participants
Yes 20 28 48
No 148 145 293
Missing 3 0 3
[1]
Measure Description: 173 evaluable patients in short term group and 171 in the long term group
1.Primary Outcome
Title Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years
Hide Description Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemical failure (Phoenix criteria: PSA nadir plus 2 ng/ml).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Long Term Androgen Deprivation Short Term Androgen Deprivation
Hide Arm/Group Description:
  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

  • Bicalutamide 50 mg tablet every day for 2 months
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy

Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

- Bicalutamide 50 mg tablet every day for 2 months

Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

Overall Number of Participants Analyzed 177 178
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
90
(87 to 92)
81
(78 to 81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long Term Androgen Deprivation, Short Term Androgen Deprivation
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
1.12 to 3.15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years
Hide Description Metastasis free survival: defined as the time from inclusion in the study (randomization) until the appearance of distant metastases: a positive result in any of the tests performed (scintigraphy, chest radiography, thorax, abdominal and pelvic CT and MRI).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Long Term Androgen Deprivation Short Term Androgen Deprivation
Hide Arm/Group Description:
  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

  • Bicalutamide 50 mg tablet every day for 2 months
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy

Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

- Bicalutamide 50 mg tablet every day for 2 months

Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

Overall Number of Participants Analyzed 177 178
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94
(92 to 96)
83
(80 to 86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long Term Androgen Deprivation, Short Term Androgen Deprivation
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.31
Confidence Interval (2-Sided) 95%
1.23 to 3.85
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival: Estimated Percentage of Participants Alive at 5 Years
Hide Description Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Long Term Androgen Deprivation Short Term Androgen Deprivation
Hide Arm/Group Description:
  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

  • Bicalutamide 50 mg tablet every day for 2 months
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy

Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

- Bicalutamide 50 mg tablet every day for 2 months

Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

Overall Number of Participants Analyzed 177 178
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
95
(93 to 97)
86
(83 to 89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Long Term Androgen Deprivation, Short Term Androgen Deprivation
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.48
Confidence Interval (2-Sided) 95%
1.31 to 4.68
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Cause-specific Survival
Hide Description Cause-specific survival included all deaths from prostate cancer or treatment complications, and deaths from unknown causes in patients with either active cancer or a previously documented relapse
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Long Term Androgen Deprivation Short Term Androgen Deprivation
Hide Arm/Group Description:
  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

  • Bicalutamide 50 mg tablet every day for 2 months
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy

Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

- Bicalutamide 50 mg tablet every day for 2 months

Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

Overall Number of Participants Analyzed 177 178
Measure Type: Number
Unit of Measure: participants
177 173
5.Secondary Outcome
Title Late Toxicity
Hide Description

Defined as the maximal rectal, urinary and cardiovascular (CV) toxicity per patient more than 90 days after completion of RT.

Scoring scales used were the radiation morbidity scoring criteria of the European Organization for Research and Treatment of Cancer–Radiation Therapy Oncology Group (EORTC/RTOG) and the Common Terminology Criteria for Adverse Events (CTCAEs) v 3.0 for the remained toxicity.

CV events were defined according to the World Health Organization criteria

Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Long Term Androgen Deprivation Short Term Androgen Deprivation
Hide Arm/Group Description:
  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

  • Bicalutamide 50 mg tablet every day for 2 months
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy

Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

- Bicalutamide 50 mg tablet every day for 2 months

Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

Overall Number of Participants Analyzed 177 178
Measure Type: Number
Unit of Measure: percentage of patients
Grade 2 of more rectal toxicity 11.1 7.6
Grade 2 of more urinary toxicity 8.2 7.3
Cardiovascular 17.6 7.2
Time Frame 63 months (IQR 50–82)
Adverse Event Reporting Description Maximum toxicity per patient
 
Arm/Group Title Long Term Androgen Deprivation Short Term Androgen Deprivation
Hide Arm/Group Description
  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

  • Bicalutamide 50 mg tablet every day for 2 months
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

  • Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
  • Bicalutamide 50 mg tablet every day for 2 months
  • High dose conformal radiotherapy

Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)

- Bicalutamide 50 mg tablet every day for 2 months

Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)

All-Cause Mortality
Long Term Androgen Deprivation Short Term Androgen Deprivation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Long Term Androgen Deprivation Short Term Androgen Deprivation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/177 (20.34%)      29/178 (16.29%)    
Cardiac disorders     
Miocardial Infarction/Ischemic disease  1  11/177 (6.21%)  11 4/178 (2.25%)  4
Infections and infestations     
Sepsis  1  2/177 (1.13%)  2 4/178 (2.25%)  4
Musculoskeletal and connective tissue disorders     
Osteoporotic fracture  1  2/177 (1.13%)  2 0/178 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Second malignancies  1  12/177 (6.78%)  12 14/178 (7.87%)  15
Vascular disorders     
Tromboembolic disease  1  4/177 (2.26%)  4 4/178 (2.25%)  4
Cerebrovascular accident (CVA)  1  5/177 (2.82%)  5 3/178 (1.69%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Long Term Androgen Deprivation Short Term Androgen Deprivation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/177 (35.03%)      40/178 (22.47%)    
Gastrointestinal disorders     
Rectal bleeding  1 [1]  12/177 (6.78%)  12 14/178 (7.87%)  14
General disorders     
Asthenia  1  13/177 (7.34%)  13 3/178 (1.69%)  3
Metabolism and nutrition disorders     
Hot flashes  1 [1]  28/177 (15.82%)  28 13/178 (7.30%)  13
Renal and urinary disorders     
Urinary toxicity  1 [1]  9/177 (5.08%)  9 10/178 (5.62%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
Grade 2 or more according EORTC/RTOG and CTCAE v 3.0
  • Relatively short follow-up and low number of events.
  • The lack of patient-reported outcomes.
  • Our decision to include vascular events other than strictly cardiac events (e.g. the presence of CVA or thromboembolic disease).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Almudena Zapatero
Organization: Hospital Universitario de la Princesa; Health Research Institute IIS from Hospital Universitario de la Princesa
Phone: +34 91 520 23 15
EMail: almudena.zapatero@salud.madrid.org
Publications of Results:
Layout table for additonal information
Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT02175212     History of Changes
Other Study ID Numbers: DART01/05
First Submitted: June 23, 2014
First Posted: June 26, 2014
Results First Submitted: May 4, 2016
Results First Posted: November 4, 2016
Last Update Posted: September 5, 2019