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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003323 |
RATIONALE: Male hormones can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide and finasteride may fight prostate cancer by reducing the production of male hormones.
PURPOSE: Phase II trial to study the effectiveness of flutamide and finasteride in treating prostate cancer patients with high PSA levels who were previously treated with radiation therapy or radical prostatectomy.
Condition | Intervention | Phase |
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Prostate Cancer Sexual Dysfunction and Infertility |
Drug: finasteride Drug: flutamide Procedure: quality-of-life assessment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | May 1998 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive finasteride and flutamide by mouth three times a day. Patients experiencing recurrence or a greater than 4 nu/mL (above 50%) increase in PSA level will discontinue flutamide treatments. Otherwise, patients continue therapy in the absence of unacceptable toxicity or disease progression.
Quality of life is assessed prior to therapy and at 3 and 6 months.
Patients are followed every 3 months for one year and every 6 months thereafter.
PROJECTED ACCRUAL: This study will accrue 100 patients over 2 years.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Prior definitive therapy must have occurred at least 6 months, but no more than 10 years, prior to study
Definitive therapy is defined as one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Joel Picus, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Study ID Numbers: | CDR0000066274, CLB-9782 |
Study First Received: | November 1, 1999 |
Last Updated: | August 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00003323 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer sexual dysfunction and infertility |
Finasteride Genital Diseases, Female Infertility Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Flutamide Genital Diseases, Male Adenocarcinoma Hormones Prostatic Neoplasms Recurrence |
Infertility Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Urogenital Neoplasms Enzyme Inhibitors Genital Diseases, Male |
Pharmacologic Actions Genital Diseases, Female Finasteride Neoplasms Neoplasms by Site Prostatic Neoplasms |