Status:
COMPLETED
Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Sanofi
Conditions:
Prostate Cancer
Eligibility:
MALE
21+ years
Phase:
PHASE2
Brief Summary
This study was a prospective analysis in men with localized prostate cancer who had rising Prostate Specific Antigen (PSA) levels after definitive treatment with surgery or radiation. Patients receive...
Detailed Description
The standard first line treatment for men with early stage newly diagnosed localized prostate cancer is a surgical removal of the prostate, localized external beam radiation, brachytherapy, or a combi...
Eligibility Criteria
Inclusion
- Biochemical relapse (rising PSA) after initial treatment (radiation therapy, brachytherapy, or radical prostatectomy) for histologically or cytologically confirmed adenocarcinoma of the prostate
- Clinical stage A2, B, C, D1
- Age: older than 21 years old
- Performance status of 0 or 1
- Pretreatment serum testosterone, normal range (or no clinical evidence of testosterone deficiency).
- If less than 30 months since completion of radiation therapy, biopsy of prostate suggested within 6 months of study entry. If more than or equal to 30 months since completion of radiation therapy, biopsy of prostate suggested within 1 year.
- Written informed consent.
Exclusion
- Abnormal bone scan suggestive of metastatic osseous disease.
- Previous hormonal manipulation including orchiectomy or any medication with significant antiandrogenic activity (combined androgen suppression over 9 months, monotherapy antiandrogens, estrogens, ketoconazole). \*Neoadjuvant androgen suppression therapy of less than or equal to 3 months is allowed, if this androgen suppression therapy was completed more than or equal to 1 year prior to study enrollment AND if the Testosterone level is within the normal ranges.
- Any systemic chemotherapy or curative radiotherapy within 6 months.
- Hepatic dysfunction:
- Total bilirubin greater than 2.0 mg/dl
- Aspartate transaminase (AST; SGOT) greater than 3 times the upper limit of normal range
- Lactate dehydrogenase (LDH) greater than 3 times the upper limit of normal range).
- Renal dysfunction:
- Blood urea nitrogen (BUN) greater than 40 mg/dl
- Serum Creatinine greater than 2.0 mg/dl.
- History or presence of other malignancy within the last 5 years (except treated squamous/basal cell carcinoma of the skin or superficial bladder carcinoma).
- Hypersensitivity to flutamide or leuprolide.
Key Trial Info
Start Date :
January 8 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2012
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00223665
Start Date
January 8 1997
End Date
September 6 2012
Last Update
August 7 2018
Active Locations (1)
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1
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109