Status:
ACTIVE_NOT_RECRUITING
Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Royal Victoria Regional Health Centre
Princess Margaret Hospital, Canada
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectom...
Detailed Description
Radical prostatectomy is a common treatment for localized prostate cancer, patients with a detectable and/or rising PSA after radical prostatectomy may be offered radiation. An increasing number of pa...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy
- Completed written informed consent
- Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires
- A detectable PSA ≤ 2.0 ng/ml
- Two consecutive rises in PSA and final PSA \> 0.1 ng/ml OR three or more consecutive rises in PSA
Exclusion
- Gross residual disease (per conventional imaging, i.e. CT and/or MRI)
- Histological or radiological node +ve (N1) or distant metastases (M1)
- Prior pelvic radiotherapy
- Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2034
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04848909
Start Date
June 3 2021
End Date
December 1 2034
Last Update
May 15 2025
Active Locations (1)
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1
Sunnybrook Odette Cancer Centre
Toronto, Onatrio, Canada, M4N 3M5