stereotactic body radiotherapy (SBRT): Stereotactic body or external-beam radiation therapy (SBRT) is a method of delivery of radiation in precision manner to the prostate bed in this study. The SBRT dose prescription will be 3000 cGy in 5 fractions to the prostate bed and 2500 cGy in 5 fractions to the pelvic nodes if elective nodal irradiation (ENI) is used, delivered every other business day.
Study 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-prostatectomy radiation.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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)
Primary outcome measure(s)
Early Adverse Events/toxicities experience by Participants — 6.5 years Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Trial sites (1)
Facility
City
Region
Status
Sunnybrook Odette Cancer Centre
Toronto
Onatrio
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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