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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
174

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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