Overview
FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
Status:
Unknown status
Unknown status
Trial end date:
2015-04-01
2015-04-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Tampere University
University of TampereCollaborator:
Finnish Prostate Cancer GroupTreatments:
Androgens
Goserelin
Criteria
• 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
-