Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers (PCS IV)
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Stage T3 T4, PSA > 20, Gleason Score > 7
Eligibility Criteria
Inclusion Criteria: To have at least one of the following three risk factors: Tumour classified T3 or T4 Gleason score 8-10 Prostate-specific antigen (PSA) level > 20 Performance status score of 0-1. Patients must sign a consent form before the start of the study. No evidence of regional disease: clinically negative regional adenopathies are revealed by imaging (computed axial tomography [CAT] scan, magnetic resonance imaging [MRI], lymphography) or surgical staging or negative pelvic node dissection. No distant metastasis. These patients must all have a negative bone scan 12 weeks prior to randomization. Hormonal therapy is allowed up to a maximum of two months before the consent form is signed, as long as the initial work-up was done, including having the requested deadlines respected. Patients with a previous history of cancer are eligible on the condition that they have not had any disease progression for more than five years. The patient must be available for treatments and follow-up visits. Treatments must start in the three weeks following randomization. Exclusion Criteria: Severe medical or psychiatric problems that could compromise study compliance. Chronic hepatic disease, abnormal hepatic functions, i.e. aspartate aminotransferase, alanine aminotransferase > 1.5 times the upper normal limit.
Sites / Locations
- Centre de Recherche Clinique du CHUS
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm 1 : 36 months AB + RT
Arm 2 : 18 months AB + RT
Androgen blockade : 36 months of androgen blockade : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 12 Q 3 months + radiation therapy : pelvis 44 grays , prostate 70 grays (2 grays/fraction)
Androgen blockade 18 months : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 6 Q 3 months + radiation therapy ( pelvis 44 grays , prostate 70 grays ,2 grays/fraction)