Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.
In calender year 2005, 220, 000 men will be diagnosed with prostate cancer and approximately 30,000 will subsequently die of metastatic disease. Although the vast majority of men will be diagnosed with clinically localized and potentially curable disease, the selection of one local modality over another remains a focus of significant controversy within the uro-oncology community. However, patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy. Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities. Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy, favorable long-term biochemical outcomes have been reported for patients with low, intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities (1,2). Several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy (65-70 Gy)results in improvement in disease-free and overall survival in patients with locally advanced prostate cancer (3,4).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant
9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).
9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).
Seattle Prostate Institute
Seattle, Washington, United States
Groupe Health Cooperative, Veterans Adminstration Hospital and University of Washington
Seattle, Washington, United States
Schiffler Cancer Center
Wheeling, West Virginia, United States
PSA 3 and 6 months following implantation then every 6 months.
PSA 3 and 6 months following implantation then every 6 months.
Time frame: 3 and 6 months following implantation then every 6 months
Serum testosterone levels at 3 and 6 months in hormonally manipulated patients.
Serum testosterone levels at 3 and 6 months in hormonally manipulated patients
Time frame: 3 and 6 months
Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.
Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.
Time frame: as needed
EPIC on 6 and 12 months and then annually.
EPIC on 6 and 12 months and then annually.
Time frame: 6 and 12 months and then annually.
Hormonally manipulated patients will obtain a DEXA scan.
Hormonally manipulated patients will obtain a DEXA scan.
Time frame: as needed
For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.
For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.
Time frame: every 3 months is recommended.
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