Title
Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
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.
Phase
Phase 3Lead Sponsor
Universidad Autonoma de MadridStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Prostate AdenocarcinomaIntervention/Treatment
goserelin bicalutamide ...Study Participants
362The 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.
Minimum dose of 76 Gy (range 76-82 Gy)
Minimum dose of 76 Gy (range 76-82 Gy)
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 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
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
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
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
| Event Type | Organ System | Event Term | Long Term Androgen Deprivation | Short Term Androgen Deprivation |
|---|
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).
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).
Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.
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
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
