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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2006 by University of Tampere.
Recruitment status was:  Active, not recruiting
Finnish Prostate Cancer Group
Information provided by:
University of Tampere Identifier:
First received: February 16, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
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
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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

• 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
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Please refer to this study by its identifier: NCT00293670

TUCH (Tampere University Central Hospital)
Tampere, Finland, 33521
Sponsors and Collaborators
University of Tampere
Finnish Prostate Cancer Group
Principal Investigator: Teuvo L Tammela, Professor Tampere University Central Hospital, Finland
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00293670     History of Changes
Other Study ID Numbers: 9393FN/0001
Study First Received: February 16, 2006
Last Updated: February 16, 2006

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on June 23, 2017