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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00293670 |
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Date of registration:
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16/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
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Scientific title:
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Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer |
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Date of first enrolment:
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May 1997 |
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Target sample size:
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573 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00293670 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Finland
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Contacts
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Name:
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Teuvo L Tammela, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tampere University Central Hospital, Finland |
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Key inclusion & exclusion criteria
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• 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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Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Patients With T1-4 Advanced Prostate Cancer
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Intervention(s)
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Drug: Goserelin (Zoladex)
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Primary Outcome(s)
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Time To Progression (TTP)
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Secondary Outcome(s)
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Overall and prostate cancer-specific survival, time to treatment failure, quality of life
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Secondary ID(s)
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9393FN/0001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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