|- candidate number||1215|
|- NTR Number||NTR130|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||23-aug-2005|
|- Secondary IDs||A309904 |
|- Public Title||Open randomized study of previously untreated metastatic prostate cancer patients comparing intermittent to continuous treatment with cyproterone acetate. Evaluation of step-up therapy adding an LHRH agonist upon progression is included.|
|- Scientific Title||Open randomized study of previously untreated metastatic prostate cancer patients comparing intermittent to continuous treatment with cyproterone acetate. Evaluation of step-up therapy adding an LHRH agonist upon progression is included.|
|- ACRONYM||RSG-CPA study|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Prostate cancer|
|- 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;
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
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2000|
|- planned closingdate|
|- Target number of participants||800|
|- Interventions||CPA 300 mg/day continuous versus CPA 300 mg/day intermittent.|
|- 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).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. M.F. Wildhagen|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. C.H. Bangma|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Urology|
(Source(s) of Monetary or Material Support)
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||16-aug-2005 - 15-dec-2006|