Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy
NCT ID: NCT00684905
Last Updated: 2012-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2000-04-30
2005-10-31
Brief Summary
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PURPOSE: This phase II trial is studying the side effects of giving leuprolide and bicalutamide together with implant radiation therapy and to see how well it works in treating patients with locally recurrent prostate cancer after external-beam radiation therapy.
Detailed Description
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* Determine the feasibility and patient tolerance of interstitial brachytherapy combined with androgen-deprivation therapy for patients with locally recurrent prostate cancer after prior external-beam irradiation.
* Determine the toxicity of interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
* Determine the tumor response to interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
OUTLINE: Patients receive neoadjuvant therapy comprising leuprolide acetate intramuscularly for 3 months and oral bicalutamide once daily for 30 days, beginning on the first day of leuprolide acetate administration. Patients then undergo interstitial brachytherapy implantation with I-125. Following brachytherapy, patients receive adjuvant leuprolide acetate every 3 months for an additional 6 months.
Quality of life is assessed at baseline and at every treatment and follow-up visit.
After completion of study therapy, patients are followed every 3 months for 2 years, every to 4-6 months for 3 years, and then annually thereafter.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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bicalutamide
leuprolide acetate
adjuvant therapy
neoadjuvant therapy
quality-of-life assessment
brachytherapy
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic Cancer Center
Principal Investigators
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William W. Wong, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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Other Identifiers
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7-00
Identifier Type: OTHER
Identifier Source: secondary_id
7-00
Identifier Type: OTHER
Identifier Source: secondary_id
07-00
Identifier Type: -
Identifier Source: org_study_id
NCT00956995
Identifier Type: -
Identifier Source: nct_alias