Status:
UNKNOWN
FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
Lead Sponsor:
Tampere University
Collaborating Sponsors:
Finnish Prostate Cancer Group
Conditions:
Patients With T1-4 Advanced Prostate Cancer
Eligibility:
MALE
Phase:
PHASE4
Brief Summary
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)
Eligibility Criteria
Inclusion
- • 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
- \-
Exclusion
Key Trial Info
Start Date :
May 1 1997
Trial Type :
INTERVENTIONAL
End Date :
April 1 2015
Estimated Enrollment :
573 Patients enrolled
Trial Details
Trial ID
NCT00293670
Start Date
May 1 1997
End Date
April 1 2015
Last Update
February 17 2006
Active Locations (1)
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1
TUCH (Tampere University Central Hospital)
Tampere, Finland, 33521