Conditions: Prostate Adenocarcinoma
Keywords: Patients with prostate adenocarcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 362
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: * 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 arm 2: * 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

Interventions: intervention 1: Short term androgen deprivation intervention 2: Long term androgen deprivation intervention 3: Short term androgen deprivation intervention 4: Long term androgen deprivation
Intervention descriptions: intervention 1: * 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 intervention 2: * 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 intervention 3: Minimum dose of 76 Gy (range 76-82 Gy) intervention 4: Minimum dose of 76 Gy (range 76-82 Gy)

Protocol document: