No registrations found.
ID
Source
Brief title
Health condition
Metastatic prostate cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
The primary aim of this study is to investigate whether intermittently administered CPA is superior to continuously administered CPA with respect to:
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 endpoints are:
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).
The study is an open-label, multi-centre trial, taking place in several European countries. Before being assigned to either treatment group, the patients will receive continuous oral CPA treatment of 300 mg/day in a preliminary phase (pre-phase) lasting 3-6 months, depending on their PSA response. After the pre-phase, an evaluation of hormone sensitivity will be done and patients will be stratified in good, moderate and non-responders. Non responders (stable PSA or PSA increase in the pre-phase) are withdrawn from the study.
Study objective
Intermittent androgen deprivation using CPA oral monotherapy improves the overall quality of life while achieving similar control of tumour growth to that attained by continuous CPA treatment.
Intervention
CPA 300 mg/day continuous versus CPA 300 mg/day intermittent.
P.O. Box 2040
M.F. Wildhagen
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634191
m.wildhagen@erasmusmc.nl
P.O. Box 2040
M.F. Wildhagen
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634191
m.wildhagen@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL99 |
| NTR-old | NTR130 |
| Other | : A309904 |
| ISRCTN | ISRCTN11311736 |