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

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.

Study Overview

• Status: Withdrawn
• Conditions: Recurrent Prostate Cancer; Stage I Prostate Cancer; Adenocarcinoma of the Prostate; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Radiation: brachytherapy; Radiation: image-guided radiation therapy

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (ESTIMATE): May 22, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 11-003235; NCI-2013-00647 (REGISTRY: CTRP (Clinical Trial Reporting Program))