Randomized, Multicentre, Phase III Study: Assessment of the Duration of Androgen Blockade Combined With Pelvic Irradiation in High-Risk Prostate Cancers
- 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
- Zubrod 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
- 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.
- Severe medical or psychiatric problems that could compromise study compliance.
- Chronic hepatic disease, abnormal hepatic functions, i.e. AST, ALT > 1.5 times the
upper normal limit.