| Protocol No. | RTOG-0526 | Principal Investigator | Roach III, Mack |
| Phase | II (Cancer Control) |
| Age Group | Adult | Scope | National |
| Title | A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy |
| Objective | --To evaluate the late treatment-related gastrointestinal (GI)/genitourinary (GU) adverse events of brachytherapy in patients with local tumor recurrence following EBRT for clinically localized prostate adenocarcinoma |
| Key Eligibility | * Histologically confirmed adenocarcinoma of the prostate meeting the following criteria:
- Stage I-II disease (T1-T2c) at initial diagnosis (prior to external-beam radiotherapy), meeting one of the following criteria:
-- Gleason score 7 and prostate-specific antigen (PSA) less than or equal to 10 ng/mL
-- Gleason score 2-7 and PSA less than or equal to 20 ng/mL
- Locally recurrent disease > 30 months after completion of prior external-beam radiotherapy
-- Has undergone prostate biopsy within the past 180 days
* Prostate volume </= 45 mL as measured by transrectal ultrasound or pubic arch interference ruled out
* American Urological Association (AUA) Symptom Index Score < 15 |
| Applicable Disease Sites | Prostate |
| Therapies Involved | Radiotherapy |
| Status | Open |
| Participating Institutions | Parnassus : Marilyn Robinson University of California San Francisco : Marilyn Robinson |
| Eligibility Document | RTOG-0526_CTGovEligibility_NCT00450411.doc |
| Contact | Marilyn Robinson |
Phone:415-353-4294
Pager:
Email:robinsonmg@radonc.ucsf.edu |