Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation
N/A
N/A
Male
Prostate Cancer
Trial Information
Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation
OBJECTIVES:
- 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Feasibility
Safety Issue:
No
Principal Investigator
William W. Wong, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
07-00
NCT ID:
NCT00684905
Start Date:
April 2000
Completion Date:
October 2005
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- recurrent prostate cancer
- stage I prostate cancer
- stage II prostate cancer
- stage III prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
