Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer

February 20, 2024 updated by: Marc Gaudet, CSSS de Gatineau

Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Gatineau, Quebec, Canada, J8P 7H2
        • CSSS de Gatineau

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

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HDR brachytherapy monotherapy
Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments.
Radiation: HDR brachytherapy monotherapy

Radiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following:

Prostate :

  • V100 > 95%
  • V150 30-35%
  • V200 < 15%
  • D90 > 90% (12,15Gy)

Bladder

• V75 < 1cc

Rectum

• V75 < 1cc

Urethra

V125 = 0cc D10 < 120%

Treatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 5 years
Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genito-urinary (GU) toxicity
Time Frame: 6 weeks, 2 years and 5 years post treatment
Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires.
6 weeks, 2 years and 5 years post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
5 years
Gastro-Intestinal (GI) Toxicity
Time Frame: 6 weeks, 2 years and 5 years post treatment
Toxicity according to Expanded Prostate Index Composite (EPIC) questionnaires.
6 weeks, 2 years and 5 years post treatment

Collaborators and Investigators

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

Sponsor

CSSS de Gatineau

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

April 1, 2014

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 23, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimated)

March 4, 2014

Study Record Updates

Last Update Posted (Actual)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSSSG-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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