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.
Overview
- Phase
- Phase 3
- Intervention
- Long term androgen deprivation
- Conditions
- Prostate Adenocarcinoma
- Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Enrollment
- 362
- Locations
- 1
- Primary Endpoint
- Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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
Intervention: Long term androgen deprivation
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
Intervention: Short term androgen deprivation
Outcomes
Primary Outcomes
Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years
Time Frame: 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).
Secondary Outcomes
- Late Toxicity(5 years)
- Overall Survival: Estimated Percentage of Participants Alive at 5 Years(5 years)
- Cause-specific Survival(5 years)
- Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years(5 years)