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
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

Erasmus MC
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone +31 (0)10 463 4191
Email m.wildhagen@erasmusmc.nl

Study information

Study designRandomised, active controlled, parallel group multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleOpen 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 acronymRSG-CPA study
Study objectivesIntermittent 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) studiedProstate Cancer
InterventionCPA 300 mg/day continuous versus CPA 300 mg/day intermittent
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Cyproterone Acetate (CPA) oral monotherapy
Primary outcome measure1. 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 measures1. 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 date01/01/2000
Completion date31/12/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants800
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2000
Date of final enrolment31/12/2003

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus MC
Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
University/education

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Industry

Schering AG (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 21/11/2013 20/08/2021 Yes No

Editorial Notes

20/08/2021: Publication reference added.