Internal Radiation Therapy in Treating Patients With Low-Risk Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients

Conditions
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Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Intervention / Treatment
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* Radiation: brachytherapy
* Radiation: image-guided radiation therapy
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (image-guided HDR brachytherapy)<br>Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days. | Radiation: brachytherapy<br>* Undergo image-guided HDR brachytherapy<br>* Other names: therapy, low-LET implant;Radiation: image-guided radiation therapy<br>* Undergo image-guided HDR brachytherapy<br>Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical PSA control using the Phoenix definition of PSA nadir + 2 |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Changes in HR-QOL as determined by IPSS scores |  | Up to 24 months |