Trial Outcomes & Findings for Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer (NCT NCT02175212)
NCT ID: NCT02175212
Last Updated: 2020-11-20
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
362 participants
Primary outcome timeframe
5 years
Results posted on
2020-11-20
Participant Flow
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.
Participant milestones
| Measure |
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
* 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)
|
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
* 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 Study
STARTED
|
177
|
178
|
|
Overall Study
COMPLETED
|
14
|
31
|
|
Overall Study
NOT COMPLETED
|
163
|
147
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
Long Term Androgen Deprivation
n=177 Participants
* 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)
|
Short Term Androgen Deprivation
n=178 Participants
* 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
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 Years
n=5 Participants
|
72 Years
n=7 Participants
|
71 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
|
Risk subgroup (intermediate vs. high)
Intermediate
|
85 participants
n=5 Participants
|
81 participants
n=7 Participants
|
166 participants
n=5 Participants
|
|
Risk subgroup (intermediate vs. high)
High
|
92 participants
n=5 Participants
|
97 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
T stage (categorical)
T1: tumor neither palpable not visible by imaging
|
38 participants
n=5 Participants
|
42 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
T stage (categorical)
T2: Tumor confinent whitin prostate
|
100 participants
n=5 Participants
|
103 participants
n=7 Participants
|
203 participants
n=5 Participants
|
|
T stage (categorical)
T3: Tumor extends through the prostate capsule
|
39 participants
n=5 Participants
|
33 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
PSA (continous)
|
11.1 nanogrames per milliliter (ng/mL)
n=5 Participants
|
11.0 nanogrames per milliliter (ng/mL)
n=7 Participants
|
11 nanogrames per milliliter (ng/mL)
n=5 Participants
|
|
PSA (categorical)
<10 ng/mL
|
80 participants
n=5 Participants
|
74 participants
n=7 Participants
|
154 participants
n=5 Participants
|
|
PSA (categorical)
10-20 ng/mL
|
61 participants
n=5 Participants
|
64 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
PSA (categorical)
>20 ng/mL
|
36 participants
n=5 Participants
|
40 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Gleason score (categorical)
<=6
|
21 participants
n=5 Participants
|
30 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Gleason score (categorical)
7
|
110 participants
n=5 Participants
|
103 participants
n=7 Participants
|
213 participants
n=5 Participants
|
|
Gleason score (categorical)
8-10
|
46 participants
n=5 Participants
|
45 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Positive biopsy samples (continous)
|
4 number of cylindres
n=5 Participants
|
4 number of cylindres
n=7 Participants
|
4 number of cylindres
n=5 Participants
|
|
Prostate radiotherapy dose (continous)
|
78.0 Grays (Gy)
n=5 Participants
|
78.0 Grays (Gy)
n=7 Participants
|
78.0 Grays (Gy)
n=5 Participants
|
|
Prostate radiotherapy dose (categorical)
<78 Gy
|
43 participants
n=5 Participants
|
51 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Prostate radiotherapy dose (categorical)
>= 78 Gy
|
128 participants
n=5 Participants
|
122 participants
n=7 Participants
|
250 participants
n=5 Participants
|
|
Pelvic radiotherapy (categorical)
Yes
|
20 participants
n=5 Participants
|
28 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Pelvic radiotherapy (categorical)
No
|
148 participants
n=5 Participants
|
145 participants
n=7 Participants
|
293 participants
n=5 Participants
|
|
Pelvic radiotherapy (categorical)
Missing
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsBiochemical 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).
Outcome measures
| Measure |
Long Term Androgen Deprivation
n=177 Participants
* 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)
|
Short Term Androgen Deprivation
n=178 Participants
* 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)
|
|---|---|---|
|
Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years
|
90 percentage of patients
Interval 87.0 to 92.0
|
81 percentage of patients
Interval 78.0 to 81.0
|
SECONDARY outcome
Timeframe: 5 yearsMetastasis 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).
Outcome measures
| Measure |
Long Term Androgen Deprivation
n=177 Participants
* 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)
|
Short Term Androgen Deprivation
n=178 Participants
* 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)
|
|---|---|---|
|
Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years
|
94 percentage of participants
Interval 92.0 to 96.0
|
83 percentage of participants
Interval 80.0 to 86.0
|
SECONDARY outcome
Timeframe: 5 yearsOverall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.
Outcome measures
| Measure |
Long Term Androgen Deprivation
n=177 Participants
* 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)
|
Short Term Androgen Deprivation
n=178 Participants
* 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 Survival: Estimated Percentage of Participants Alive at 5 Years
|
95 percentage of patients
Interval 93.0 to 97.0
|
86 percentage of patients
Interval 83.0 to 89.0
|
SECONDARY outcome
Timeframe: 5 yearsCause-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
Outcome measures
| Measure |
Long Term Androgen Deprivation
n=177 Participants
* 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)
|
Short Term Androgen Deprivation
n=178 Participants
* 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)
|
|---|---|---|
|
Cause-specific Survival
|
177 participants
|
173 participants
|
SECONDARY outcome
Timeframe: 5 yearsDefined 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
Outcome measures
| Measure |
Long Term Androgen Deprivation
n=177 Participants
* 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)
|
Short Term Androgen Deprivation
n=178 Participants
* 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)
|
|---|---|---|
|
Late Toxicity
Grade 2 of more rectal toxicity
|
11.1 percentage of patients
|
7.6 percentage of patients
|
|
Late Toxicity
Grade 2 of more urinary toxicity
|
8.2 percentage of patients
|
7.3 percentage of patients
|
|
Late Toxicity
Cardiovascular
|
17.6 percentage of patients
|
7.2 percentage of patients
|
Adverse Events
Long Term Androgen Deprivation
Serious events: 36 serious events
Other events: 62 other events
Deaths: 0 deaths
Short Term Androgen Deprivation
Serious events: 29 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Long Term Androgen Deprivation
n=177 participants at risk
* 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)
|
Short Term Androgen Deprivation
n=178 participants at risk
* 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)
|
|---|---|---|
|
Cardiac disorders
Miocardial Infarction/Ischemic disease
|
6.2%
11/177 • Number of events 11 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
2.2%
4/178 • Number of events 4 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
|
Vascular disorders
Tromboembolic disease
|
2.3%
4/177 • Number of events 4 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
2.2%
4/178 • Number of events 4 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
|
Vascular disorders
Cerebrovascular accident (CVA)
|
2.8%
5/177 • Number of events 5 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
1.7%
3/178 • Number of events 3 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
1.1%
2/177 • Number of events 2 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
0.00%
0/178 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second malignancies
|
6.8%
12/177 • Number of events 12 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
7.9%
14/178 • Number of events 15 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
|
Infections and infestations
Sepsis
|
1.1%
2/177 • Number of events 2 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
2.2%
4/178 • Number of events 4 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
Other adverse events
| Measure |
Long Term Androgen Deprivation
n=177 participants at risk
* 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)
|
Short Term Androgen Deprivation
n=178 participants at risk
* 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)
|
|---|---|---|
|
Gastrointestinal disorders
Rectal bleeding
|
6.8%
12/177 • Number of events 12 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
7.9%
14/178 • Number of events 14 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
|
Renal and urinary disorders
Urinary toxicity
|
5.1%
9/177 • Number of events 9 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
5.6%
10/178 • Number of events 10 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
|
General disorders
Asthenia
|
7.3%
13/177 • Number of events 13 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
1.7%
3/178 • Number of events 3 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
|
Metabolism and nutrition disorders
Hot flashes
|
15.8%
28/177 • Number of events 28 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
7.3%
13/178 • Number of events 13 • 63 months (IQR 50-82)
Maximum toxicity per patient
|
Additional Information
Dr. Almudena Zapatero
Hospital Universitario de la Princesa; Health Research Institute IIS from Hospital Universitario de la Princesa
Phone: +34 91 520 23 15
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place