Status:
COMPLETED
Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide and bicalutamide, may lessen the amount of androgens made by the body. Implant radiation the...
Detailed Description
OBJECTIVES: * Determine the feasibility and patient tolerance of interstitial brachytherapy combined with androgen-deprivation therapy for patients with locally recurrent prostate cancer after prior ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Biopsy-proven adenocarcinoma of the prostate
- Locally recurrent disease, defined by digital rectal examination and/or rising prostate-specific antigen (PSA)
- No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination, bone scan, or CT scan of the pelvis
- Clinical stage T1c-T3a disease at the time of recurrence
- PSA \< 10 ng/mL
- Prostate volume by transrectal ultrasonography \< 60 cc
- Received prior external beam radiotherapy
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- WBC ≥ 3,000/μL
- Platelet count ≥ 90,000/μL
- Hemoglobin ≥ 10 g/dL
- Alkaline phosphatase \< 2 times normal
- AST \< 2 times normal
- Normal prothrombin time and partial thromboplastin time
- No significant obstructive urinary symptoms (AUA score ≤ 16)
- No contraindication for general anesthesia
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior transurethral resection of the prostate
Exclusion
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00684905
Start Date
April 1 2000
End Date
October 1 2005
Last Update
November 12 2012
Active Locations (1)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259