Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer
|Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer||Radiation: brachytherapy Radiation: image-guided radiation therapy Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients|
- Biochemical PSA control using the Phoenix definition of PSA nadir + 2 [ Time Frame: 5 years ]
- Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0 [ Time Frame: 3 months ]
- Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0 [ Time Frame: 6 months ]
- Changes in health related quality of life (HR-QOL) as determined by EPIC scores [ Time Frame: Up to 24 months ]
- Changes in HR-QOL as determined by IIEF scores [ Time Frame: Up to 24 months ]
- Changes in HR-QOL as determined by IPSS scores [ Time Frame: Up to 24 months ]
|Study Start Date:||March 2012|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (image-guided HDR brachytherapy)
Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
Undergo image-guided HDR brachytherapy
Other Names:Radiation: image-guided radiation therapy
Undergo image-guided HDR brachytherapyOther: laboratory biomarker analysis
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 (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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01859689
|Principal Investigator:||Mitchell Kamrava||Jonsson Comprehensive Cancer Center|