Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
- Conditions
- Prostate Adenocarcinoma
- Interventions
- Radiation: Long term androgen deprivationRadiation: Short term androgen deprivation
- Registration Number
- NCT02175212
- Lead Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 362
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Long term androgen deprivation 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 Short 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
- Primary Outcome Measures
Name Time Method Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years 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 Outcome Measures
Name Time Method Late Toxicity 5 years 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 criteriaOverall Survival: Estimated Percentage of Participants Alive at 5 Years 5 years Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.
Cause-specific Survival 5 years 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
Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years 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).
Trial Locations
- Locations (1)
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain