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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Finnish Prostate Cancer Group
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00293670
First received: February 16, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

Resource links provided by NLM:


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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Tampere

Additional 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
Study First Received: February 16, 2006
Last Updated: February 16, 2006
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on October 23, 2014