A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Adenocarcinoma of the Prostate
- Sponsor
- Jonsson Comprehensive Cancer Center
- Primary Endpoint
- Biochemical PSA control using the Phoenix definition of PSA nadir + 2
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- •Unilateral prostate cancer as determined by prostate biopsy
- •Less than or equal to 3 positive biopsy cores
- •No biopsy core \>= 50% positive for cancer
- •Karnofsky performance status (KPS) \>= 70
- •At least a 12 core prostate biopsy; if this was not performed then it will be repeated here at University of California at Los Angeles (UCLA)
- •Artemis guided biopsy of any suspicious target lesions as identified on multiparametric (mp)-magnetic resonance imaging (MRI)
- •Clinical stage T1c or T2a
- •PSA \< 10 ng/ml
- •Gleason score 3+3=6
Exclusion Criteria
- •Patients who have previously received radiation therapy to the pelvis
- •Refusal to sign the informed consent
- •Patients who are participating in a concurrent treatment protocol
Outcomes
Primary Outcomes
Biochemical PSA control using the Phoenix definition of PSA nadir + 2
Time Frame: 5 years
Secondary Outcomes
- Changes in HR-QOL as determined by IPSS scores(Up to 24 months)
- Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0(3 months)
- Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0(6 months)
- Changes in health related quality of life (HR-QOL) as determined by EPIC scores(Up to 24 months)
- Changes in HR-QOL as determined by IIEF scores(Up to 24 months)