Description:
The standard options for men with very low risk prostate cancer include active surveillance
and the standard treatment options for low risk disease, i.e. radical prostatectomy, external
beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks to
evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk
prostate cancer. The goals of the study are to determine the biochemical disease free
survival at five years in these patients, as well as to determine the acute and late urinary,
bowel, and sexual toxicity associated with focal prostate brachytherapy using Cesium 131.
Patients eligible for the study will be men with histologically confirmed adenocarcinoma of
the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6, prostate specific
antigen(PSA) <10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum
of 12 cores sampled. Additionally, patients must have a single, dominant index lesion on MRI.
The study is a phase II study. Patients will be followed prospectively. Dosimetry will be
evaluated post-procedure, and PSAs will be obtained every three months in year one and every
six months from year two through year five. Urinary, bowel, and sexual morbidity will be
assessed by patient survey prior to treatment , two weeks, after treatment, at three month
intervals in year one and at six month intervals in years two through five.
Title
- Brief Title: Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer
- Official Title: Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
PRO14020322
- NCT ID:
NCT02290366
Conditions
Purpose
The standard options for men with very low risk prostate cancer include active surveillance
and the standard treatment options for low risk disease, i.e. radical prostatectomy, external
beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks to
evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk
prostate cancer. The goals of the study are to determine the biochemical disease free
survival at five years in these patients, as well as to determine the acute and late urinary,
bowel, and sexual toxicity associated with focal prostate brachytherapy using Cesium 131.
Patients eligible for the study will be men with histologically confirmed adenocarcinoma of
the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6, prostate specific
antigen(PSA) <10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum
of 12 cores sampled. Additionally, patients must have a single, dominant index lesion on MRI.
The study is a phase II study. Patients will be followed prospectively. Dosimetry will be
evaluated post-procedure, and PSAs will be obtained every three months in year one and every
six months from year two through year five. Urinary, bowel, and sexual morbidity will be
assessed by patient survey prior to treatment , two weeks, after treatment, at three month
intervals in year one and at six month intervals in years two through five.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Focal Therapy | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1c-T2aN0M0
- Gleason score <= 3+3=6
- prostate specific antigen (PSA) <10 ng/ml
- <= 2 cores positive out of a minimum of 12 cores sampled
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | N/A |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | biochemical disease free survival |
| Time Frame: | five years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Ronald M. Benoit, MD |
Last Updated
February 15, 2021
