RTOG-0526

A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy

Principal Investigator

Juanita Crook

Status

Disease Site

Genitourinary [GU] Other

Phase

II

Developmental Therapeutics

No

Primary 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

Data Collection Notice:

Data for this trial is being collected via the NRG/RTOG Data Center.

Patient Population

 
• Biopsy-documented locally recurrent prostatic adenocarcinoma > 30 months after the completion of EBRT, biopsied < = 180 days prior to  registration and with diagnosis confirmed by central pathology review.

 

• Disease-related characteristics at initial diagnosis (i.e., prior to EBRT) that fit the following criteria (Appendix III):  
     
  • Stages T1-T2c, Gleason scores 2-7, and PSA < = 20 ng/mL

   

   

 

• Baseline serum PSA value < 10 ng/mL performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 8 weeks prior to registration. PSA should not be performed within 10 days of a prior prostate biopsy, and if the patient has been started on hormonal therapy, the PSA should be performed within 8 weeks prior to the commencement of hormonal therapy.

Target Accrual

96