A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
Principal Investigator
Juanita Crook, MD
Status
Terminated
Date of Study Termination
May 20 2022
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.