A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
I. To determine long term 5 year prostate specific cancer (PSA) biochemical control using
the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.
I. To assess acute and late toxicity outcomes following targeted brachytherapy according to
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
II. To determine changes from baseline in health-related quality of life indicators using
the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International
Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score
III. To assess the potential value of multiparametric magnetic resonance imaging, including
dynamic contrast enhancement perfusion imaging and diffusion tensor neurovascular
tactographic imaging in predicting the development of equivocal disease (ED) following
Patients undergo 3 fractions of image-guided high-dose rate (HDR) brachytherapy over 2 days.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Biochemical PSA control using the Phoenix definition of PSA nadir + 2
Jonsson Comprehensive Cancer Center
United States: Institutional Review Board
|Jonsson Comprehensive Cancer Center||Los Angeles, California 90095|