This trial is active, not recruiting.

Condition patients with t1-4 advanced prostate cancer
Treatment goserelin (zoladex)
Phase phase 4
Sponsor University of Tampere
Collaborator Finnish Prostate Cancer Group
Start date May 1997
End date April 2015
Trial size 573 participants
Trial identifier NCT00293670, 9393FN/0001


To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Time To Progression (TTP)
time frame:

Secondary Outcomes

Overall and prostate cancer-specific survival, time to treatment failure, quality of life
time frame:

Eligibility Criteria

Male participants of any age.

• Inclusion Criteria (run-in period): T1-T4, metastatic (M1) prostate cancer T1-T4, non-metastatic (M0) prostate cancer with PSA > 60 ng/mL T3-T4, non-metastatic (M0) prostate cancer with PSA > 20ng/mL T1-T4, N+ prostate cancer WHO performance status 0-2 Written informed consent • Inclusion criteria to the randomised period: Patients who fulfilled all entry criteria of the run-in period Patients who completed the 24-week run-in period Patients who responded to the 24-week run-in period with a decrease of PSA to < 10 ng/mL. If the baseline was < 20ng/mL, at least 50% decrease from the baseline measurement is required Exclusion Criteria (run-in period): Any previous or concurrent treatment of prostate cancer, except TURP, 5-alpha reductase inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex hormone status -

Additional Information

Official title Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
Principal investigator Teuvo L Tammela, Professor
Trial information was received from ClinicalTrials.gov and was last updated in February 2006.
Information provided to ClinicalTrials.gov by University of Tampere.