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Sponsors and Collaborators: |
University of Tampere Finnish Prostate Cancer Group |
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Information provided by: | University of Tampere |
ClinicalTrials.gov Identifier: | NCT00293670 |
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)
Condition | Intervention | Phase |
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Patients With T1-4 Advanced Prostate Cancer |
Drug: Goserelin (Zoladex) |
Phase IV |
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 |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
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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Finland | |
TUCH (Tampere University Central Hospital) | |
Tampere, Finland, 33521 |
Principal Investigator: | Teuvo L Tammela, Professor | Tampere University Central Hospital, Finland |
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 |
Prostatic Diseases Genital Neoplasms, Male Goserelin Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Androgens |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |