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

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ClinicalTrials.gov Identifier: NCT00293670
Recruitment Status : Unknown
Verified February 2006 by University of Tampere.
Recruitment status was:  Active, not recruiting
First Posted : February 17, 2006
Last Update Posted : February 17, 2006
Sponsor:
Collaborator:
Finnish Prostate Cancer Group
Information provided by:
University of Tampere

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

Condition or disease Intervention/treatment Phase
Patients With T1-4 Advanced Prostate Cancer Drug: Goserelin (Zoladex) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 573 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
Study Start Date : May 1997
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Goserelin
U.S. FDA Resources




Primary Outcome Measures :
  1. Time To Progression (TTP)

Secondary Outcome Measures :
  1. Overall and prostate cancer-specific survival, time to treatment failure, quality of life


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00293670     History of Changes
Other Study ID Numbers: 9393FN/0001
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: February 17, 2006
Last Verified: February 2006

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Goserelin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents