A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer
- To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of
external-beam radiotherapy) as definitive treatment for patients with intermediate-risk
- To assess acceptable toxicity, defined as treatment related toxicity (urinary and
rectal), no worse than that seen by patients treated with conventional therapy (grade 3
urinary toxicity < 10% and grade 3 rectal toxicity < 10%).
- To achieve adequate dosimetric coverage of the prostate comparable to current
- To assess the effect of treatment on sexual function.
OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.
Patients complete bladder, bowel, sexual function, and quality of life questionnaires,
including the International Index of Erectile Function (IIEF) questionnaire, the
International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life
questionnaire at baseline and then at every follow-up visit.
After completion of study treatment, patients are followed every 3 months for 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
At scheduled 3 month intervals for one year
Josh Yamada, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|