Metastatic prostate cancer
Conditions
Interventions
CPA 300 mg/day continuous versus CPA 300 mg/day intermittent.
Sponsors
Dept. Urology Erasmus MC
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 PSA serum level: PSA ³ 20 ng/ml and PSA £ 1000 ng/ml; 4. WHO performance status 0, 1 or 2; 5. No specific treatment for prostate cancer except for radical prostatectomy, TURp or radical radiotherapy. Any neo-adjuvant treatment prior to curative treatment must have been completed more than 6 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 (AST or ALT higher than 2.5 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 and/or; 2. Time to clinical disease progression after at least three months of continuous CPA and; 3. Quality of life and; 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 and/or; 2. Time to clinical disease progression after castration and; 3. Time to disease specific mortality; 4. Overall mortality (all causes). | — |
Contacts
Public ContactM.F. Wildhagen
Erasmus Medical Center, P.O. Box 2040
Outcome results
None listed