Prostate Cancer Cancer Prostate cancer
Conditions
Interventions
CPA 300 mg/day continuous versus CPA 300 mg/day intermittent
Sponsors
Erasmus Medical Centre (Netherlands)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven prostate cancer 2. M1a, M1b or M1c, irrespective of T-stage or N-stage 3. Increased Prostate Specific Antigen (PSA) serum level: PSA greater than or equal to 20 ng/ml and PSA less than 1000 ng/ml 4. World Health Organisation (WHO) performance status zero, one or two 5. No specific treatment for prostate cancer except for radical prostatectomy, Transurethral Resection of the Prostate (TURP) or radical radiotherapy. Any neo-adjuvant treatment prior to curative treatment must have been completed more than six months before entering the study 6. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. N+ M0, patients with regional lymph node metastases only are excluded 2. Orchiectomy 3. Testosterone in the castration range at registration 4. Life expectancy of less than 12 months 5. Presence or history of other neoplasms, unless considered cured (no evidence or tumour or at least five years) 6. Presence of progressive fatal disease other than prostate cancer 7. Presence of liver diseases (Aspartate Aminotransferase [AST] or Alanine Aminotransferase [ALT] higher than 25 times upper limit of normal) 8. Presence of sickle cell anaemia 9. Clinically relevant major systemic disease making implementation of the protocol or interpretation of the study results difficult 10. History of or presently known depressions or psychiatric disorders 11. Probable non-compliance to trial protocol 12. Hypersensitivity to CPA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to PSA progression after at least three months of continuous CPA 2. Time to clinical disease progression after at least three months of continuous CPA 3. Quality of life 4. The ratio and length of time without anti-androgenic treatment in the intermittent arm of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to secondary PSA progression after castration 2. Time to clinical disease progression after castration 3. Time to disease specific mortality 4. Overall mortality (all causes) | — |
Countries
Netherlands
Outcome results
None listed