Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer

Study Overview
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Brief Summary
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The present study is a phase III randomized and multicentric trial evaluating the potential additional impact effect of two years adjuvant androgen deprivation when combined with neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk prostate cancer patients. Stratification will be performed by prognostic factors and by participating institution.

Official Title
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Phase III Multicenter Randomized Trial of Adjuvant Androgen Deprivation in Combination With Three-dimensional Conformal Radiotherapy Doses in High and Intermediate Risk Localized Prostate Cancer.

Conditions
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Prostate Adenocarcinoma

Intervention / Treatment
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* Drug: Short term androgen deprivation
* Drug: Long term androgen deprivation
* Radiation: Short term androgen deprivation
* Radiation: Long term androgen deprivation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological proven adenocarcinoma of the prostate Stage: cT1c-3b N0M0 according to American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Prostatic Specific Antigen (PSA)<100 ng/ml Intermediate (T1-T2 with Gleason Score [GS] 7 and/or PSA 10-20) High risk (T3 and/or GS 8-10 and/or PSA > 20) Karnofsky Index (KI) performance status ≥70% Written informed consent Exclusion Criteria: T4 N1 M1, Previous surgical treatment (prostatectomy or cryosurgery) Neoadjuvant hormonal treatment > 3 months. History of pelvic radiotherapy (RT) Contraindications for radiotherapy Concomitant use of chemotherapy Serious psychiatric or medical condition Current synchronic malignancies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long term androgen deprivation<br>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 | Drug: Long term androgen deprivation<br>* 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<br>* Other names: Neoadjuvant, concomitant and adjuvant;Radiation: Long term androgen deprivation<br>* Minimum dose of 76 Gy (range 76-82 Gy)<br>|
| Active Comparator: Short term androgen deprivation<br>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 | Drug: Short term androgen deprivation<br>* 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<br>* Other names: Neoadjuvant and concomitant;Radiation: Short term androgen deprivation<br>* Minimum dose of 76 Gy (range 76-82 Gy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years | 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). | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years | 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). | 5 years | 
| Overall Survival: Estimated Percentage of Participants Alive at 5 Years | Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause. | 5 years | 
| Cause-specific Survival | 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 | 5 years | 
| Late Toxicity | 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 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with prostate adenocarcinoma