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NCT00293670 Clinical Trial

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

Patients With T1-4 Advanced Prostate Cancer Clinical Trial

Official title:
Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00293670
Other study ID # 9393FN/0001
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received February 16, 2006
Last updated February 16, 2006
Start date May 1997
Est. completion date April 2015

Study information
Verified date February 2006
Source University of Tampere
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 573
Est. completion date April 2015
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility • 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Goserelin (Zoladex)

Locations
Country Name City State
Finland TUCH (Tampere University Central Hospital) Tampere

Sponsors (2)
Lead Sponsor Collaborator
University of Tampere Finnish Prostate Cancer Group

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time To Progression (TTP)
Secondary Overall and prostate cancer-specific survival, time to treatment failure, quality of life