Open randomised study of previously untreated metastatic prostate cancer patients comparing intermittent to continuous treatment with cyproterone acetate: evaluation of step-up therapy adding an luteinising hormone releasing hormone agonist upon progression is included
ISRCTN | ISRCTN11311736 |
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DOI | https://doi.org/10.1186/ISRCTN11311736 |
Secondary identifying numbers | A309904 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 20/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M F Wildhagen
Scientific
Scientific
Erasmus MC
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Phone | +31 (0)10 463 4191 |
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m.wildhagen@erasmusmc.nl |
Study information
Study design | Randomised, active controlled, parallel group multicentre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | Open randomised study of previously untreated metastatic prostate cancer patients comparing intermittent to continuous treatment with cyproterone acetate: evaluation of step-up therapy adding an luteinising hormone releasing hormone agonist upon progression is included |
Study acronym | RSG-CPA study |
Study objectives | Intermittent androgen deprivation using Cyproterone Acetate (CPA) oral monotherapy improves the overall quality of life while achieving similar control of tumour growth to that attained by continuous CPA treatment. |
Ethics approval(s) | Ethics approval received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Prostate Cancer |
Intervention | CPA 300 mg/day continuous versus CPA 300 mg/day intermittent |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Cyproterone Acetate (CPA) oral monotherapy |
Primary outcome measure | 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 outcome measures | 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) |
Overall study start date | 01/01/2000 |
Completion date | 31/12/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 800 |
Key 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 |
Key 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 |
Date of first enrolment | 01/01/2000 |
Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus MC
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
University/education
University/education
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
Website | http://www.erasmusmc.nl/ |
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https://ror.org/018906e22 |
Funders
Funder type
Industry
Schering AG (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | 21/11/2013 | 20/08/2021 | Yes | No |
Editorial Notes
20/08/2021: Publication reference added.