Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
02/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M F Wildhagen

ORCID ID

Contact details

Erasmus MC
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 4191
m.wildhagen@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A309904

Study information

Scientific title

Acronym

RSG-CPA study

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Prostate Cancer

Intervention

CPA 300 mg/day continuous versus CPA 300 mg/day intermittent

Intervention type

Drug

Phase

Not Specified

Drug names

Cyproterone Acetate (CPA) oral monotherapy

Primary outcome measures

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 trial start date

01/01/2000

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

800

Participant 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

Recruitment start date

01/01/2000

Recruitment end date

31/12/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus MC
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

http://www.erasmusmc.nl/

Funders

Funder type

Industry

Funder name

Schering AG (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes