Hormone Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00003323|
Recruitment Status : Completed
First Posted : August 13, 2003
Last Update Posted : July 4, 2016
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer Sexual Dysfunction and Infertility||Drug: finasteride Drug: flutamide Other: quality-of-life assessment||Phase 2|
- Determine the efficacy of finasteride and flutamide in suppressing prostate specific antigen (PSA) levels in patients with elevated PSA after definitive radiation therapy or radical prostatectomy for prostate cancer.
- Assess sexual function and other quality of life issues during this therapy.
- Estimate the response to flutamide withdrawal in this group of patients who have not had a major reduction in circulating testosterone levels.
- Measure the response rate to further hormonal manipulation with combined androgen blockade after the failure of this therapy.
- Obtain data that may predict more aggressive disease.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 1998|
|Actual Primary Completion Date :||May 2002|
|Actual Study Completion Date :||March 2010|
Experimental: Hormone Therapy
Treatment of prostate cancer pts post radiation or surgery with potency sparing hormones
5 mg/d PODrug: flutamide
250 mg PO tidOther: quality-of-life assessment
Assessment survey administered at baseline, and 3 & 6 months post initiation of treatment
- PSA levels [ Time Frame: 1 year post treatment ]
- QOL issues associated with treatment protocol [ Time Frame: 3 & 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003323
Show 43 Study Locations
|Study Chair:||Joel Picus, MD||Washington University Siteman Cancer Center|