Adenocarcinoma of the Prostate Clinical Trial
Official title:
A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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 (IPSS)
questionnaire.
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
radiation treatment.
OUTLINE:
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.
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