A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer

April 16, 2018 updated by: Dr. Gerard Morton, Sunnybrook Health Sciences Centre

A Randomized Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer

A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

174

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
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre, Sunnybrook Health Sciences Centre

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

Male

Description

Inclusion Criteria:

  • histologically confirmed diagnosis of adenocarcinoma of the prostate
  • low and intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA < 20ng/mL. PSA to be drawn within 60 days of registration
  • prostate volume < 60 cc as determined by ultrasound, CT or MRI
  • willing to give informed consent ot participate in this clinical trial
  • able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire

Exclusion Criteria:

  • documented nodal or distant metastases
  • previous pelvic radiotherapy
  • previous trans-urethral resection of prostate, previous prostatectomy or Highly Focused Ultrasound (HIFU)
  • use of androgen deprivation therapy. Use of 5-alpha reductase inhibitors is permitted
  • poor baseline urinary function defined as radiotherapy eg. connective tissue disease or inflammatory bowel disease
  • significant medical co-morbidity rendering patient unsuitable for general anaesthetic

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HDR 2 fractions
HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart
Radiation: HDR 2 Fraction
High dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin.
Experimental: HDR 1 fraction
HDR brachytherapy of 19 Gy delivered in a single fraction
Radiation: HDR 1 Fraction
High Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life (QoL)
Time Frame: 1 year
To demonstrate that health related QoL at 1 year in the urinary and bowel domains of the Expanded Prostate Index Composite (EPIC) for at least one HDR monotherapy arm is not worse than that following current standard treatment with single fraction HDR combined with supplemental external beam radiotherapy.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GU and GI toxicities
Time Frame: baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years
To determine genito-urinary (GU) and gastro-intestinal (GI) toxicities in both study arms according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years
Urinary Symptoms
Time Frame: baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years
To determine changes in urinary symptoms in both study arms as determined by the International Prostate Symptom Score (IPSS)
baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years
Serum PSA changes
Time Frame: baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years
To determine changes in serum prostate-specific antigen (PSA) in both arms
baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years
Biochemical failure and disease free survival rates
Time Frame: 5 years
To determine PSA failure and disease free survival rates in both study arms
5 years
Erectile function
Time Frame: 5 year
To determine changes in erectile function in both study arms assessed using the International Index of Erectile Function (IIEF) scale
5 year
Associations between dosimetric parameters and toxicity/EPIC domains
Time Frame: 5 years
To explore association between dosimetric parameters and toxicity/EPIC domain change
5 years

Collaborators and Investigators

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

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Gerard Morton, MD, Sunnybrook Health Sciences Centre

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

May 1, 2013

Primary Completion (Actual)

May 1, 2017

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (Estimate)

July 1, 2013

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMOR_HDR Monotherapy RCT

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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