Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

October 6, 2017

Study Completion Date

October 6, 2017

Conditions
Prostate Cancer
Interventions
OTHER

Prostate Biopsy, Focal Brachytherapy , Assessment of QOL

A re-staging transrectal or transperineal ultrasound-guided prostate biopsy as currently performed at participating institutions. Focal brachytherapy will be performed at 8 weeks following the transrectal or transperineal biopsy or sooner if the patient has recovered from the repeat biopsy and the treating physician determines it is safe to proceed with treatment. The regions will be targeted with the prescription dose and receive 144 Gy of Iodine-125 (I-125). The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment.

Trial Locations (3)

10065

Memorial Sloan Kettering Cancer Center, New York

11040

North Shore LIJ, New Hyde Park

77030

Md Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Colorado, Denver

OTHER

collaborator

M.D. Anderson Cancer Center

OTHER

collaborator

Northwell Health

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER