Status:
UNKNOWN
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Carcinoma of the Prostate
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 ris...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01890096
Start Date
May 1 2013
End Date
May 1 2020
Last Update
April 17 2018
Active Locations (1)
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1
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5