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

This study is ongoing, but not recruiting participants.

First Received: February 16, 2006 No Changes Posted

Sponsors and Collaborators:	University of Tampere Finnish Prostate Cancer Group
Information provided by:	University of Tampere
ClinicalTrials.gov Identifier:	NCT00293670

Purpose

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

Condition	Intervention	Phase
Patients With T1-4 Advanced Prostate Cancer	Drug: Goserelin (Zoladex)	Phase IV

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

Further study details as provided by University of Tampere:

Primary Outcome Measures:

Time To Progression (TTP)

Secondary Outcome Measures:

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

Estimated Enrollment:	573
Study Start Date:	May 1997
Estimated Study Completion Date:	April 2015

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293670

Locations

Finland
TUCH (Tampere University Central Hospital)
Tampere, Finland, 33521

Sponsors and Collaborators

University of Tampere

Finnish Prostate Cancer Group

Investigators

Principal Investigator:

Teuvo L Tammela, Professor

Tampere University Central Hospital, Finland

More Information

No publications provided

Study ID Numbers:	9393FN/0001
Study First Received:	February 16, 2006
Last Updated:	February 16, 2006
ClinicalTrials.gov Identifier:	NCT00293670 History of Changes
Health Authority:	Finland: Ethics Committee

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Goserelin
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009