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

July 23, 2020 updated by: Jonsson Comprehensive Cancer Center

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Withdrawn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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 5 years
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
Time Frame: 3 months
3 months
Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0
Time Frame: 6 months
6 months
Changes in health related quality of life (HR-QOL) as determined by EPIC scores
Time Frame: Up to 24 months
Up to 24 months
Changes in HR-QOL as determined by IIEF scores
Time Frame: Up to 24 months
Up to 24 months
Changes in HR-QOL as determined by IPSS scores
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 11-003235
  • NCI-2013-00647 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe