Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
Conditions
Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
Brachytherapy, Monotherapy, HDR
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: HDR brachytherapy monotherapy
Type: Radiation
Overall Status
Recruiting
Summary
The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Male
Criteria: Inclusion Criteria:

- Biopsy proven Adenocarcinoma of the Prostate

- Clinical stage T1c, T2a or T2b

- PSA less than 20 ng/ml

- Gleason Score 6 or 7

Exclusion Criteria:

- Age less than 18 years

- Clinical stage T2c, T3 ou T4

- Clinical Stage N1

- Clinical Stage M1

- Prostate Specific Antigen (PSA) more than 20 ng/ml

- Gleason score 8 or higher

- IPSS score 19 or higher with alpha-blockers

- Past radiation therapy to the pelvis

- History of Collagen Vascular Disease

- History of Inflammatory Bowel Disease

- Bilateral Hip Prosthesis
Location
CSSS de Gatineau
Gatineau, Quebec, Canada
Status: Recruiting
Start Date
April 2014
Completion Date
September 2022
Sponsors
CSSS de Gatineau
Source
CSSS de Gatineau
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page