A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
Primary Purpose
Carcinoma of the Prostate
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
HDR 2 Fraction
HDR 1 Fraction
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma of the Prostate focused on measuring HDR, monotherapy, low, intermediate, prostate cancer
Eligibility Criteria
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
Sites / Locations
- Odette Cancer Centre, Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HDR 2 fractions
HDR 1 fraction
Arm Description
HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart
HDR brachytherapy of 19 Gy delivered in a single fraction
Outcomes
Primary Outcome Measures
Health related quality of life (QoL)
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.
Secondary Outcome Measures
GU and GI toxicities
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
Urinary Symptoms
To determine changes in urinary symptoms in both study arms as determined by the International Prostate Symptom Score (IPSS)
Serum PSA changes
To determine changes in serum prostate-specific antigen (PSA) in both arms
Biochemical failure and disease free survival rates
To determine PSA failure and disease free survival rates in both study arms
Erectile function
To determine changes in erectile function in both study arms assessed using the International Index of Erectile Function (IIEF) scale
Associations between dosimetric parameters and toxicity/EPIC domains
To explore association between dosimetric parameters and toxicity/EPIC domain change
Full Information
NCT ID
NCT01890096
First Posted
June 26, 2013
Last Updated
April 16, 2018
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01890096
Brief Title
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
Official Title
A Randomized Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of the Prostate
Keywords
HDR, monotherapy, low, intermediate, prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HDR 2 fractions
Arm Type
Experimental
Arm Description
HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart
Arm Title
HDR 1 fraction
Arm Type
Experimental
Arm Description
HDR brachytherapy of 19 Gy delivered in a single fraction
Intervention Type
Radiation
Intervention Name(s)
HDR 2 Fraction
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
HDR 1 Fraction
Intervention Description
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
Primary Outcome Measure Information:
Title
Health related quality of life (QoL)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
GU and GI toxicities
Description
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
Time Frame
baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years
Title
Urinary Symptoms
Description
To determine changes in urinary symptoms in both study arms as determined by the International Prostate Symptom Score (IPSS)
Time Frame
baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years
Title
Serum PSA changes
Description
To determine changes in serum prostate-specific antigen (PSA) in both arms
Time Frame
baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years
Title
Biochemical failure and disease free survival rates
Description
To determine PSA failure and disease free survival rates in both study arms
Time Frame
5 years
Title
Erectile function
Description
To determine changes in erectile function in both study arms assessed using the International Index of Erectile Function (IIEF) scale
Time Frame
5 year
Title
Associations between dosimetric parameters and toxicity/EPIC domains
Description
To explore association between dosimetric parameters and toxicity/EPIC domain change
Time Frame
5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Morton, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odette Cancer Centre, Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
We'll reach out to this number within 24 hrs