Overview

FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

Status:
Unknown status
Trial end date:
2015-04-01
Target enrollment:
0
Participant gender:
Male
Summary
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tampere University
University of Tampere
Collaborator:
Finnish Prostate Cancer Group
Treatments:
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

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