Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy

NCT04848909 | Active Not Recruiting DMC

• 1 other identifier: 3596
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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-prostatectomy radiation.

Conditions

Prostate Cancer

Keywords

SBRT; Ultrahypofractionated Radiotherapy; Localized Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Early Adverse Events/toxicities experience by Participants

  Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  6.5 years

Secondary Outcomes (5)

• Late Adverse Events/toxicities experienced by Participants

  6.5 years

• Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire

  6.5 years

• Biochemical disease-free survival

  6.5 years

• Health Utilities using The Patient-Oriented Prostate Utility Scale

  6.5years

• Health Utilities using EuroQol- 5 Dimension Questionnaire

  6.5years

Study Arms (1)

Men with prostate cancer post-prostatectomy

EXPERIMENTAL

Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Radiation: stereotactic body radiotherapy (SBRT)

Interventions

stereotactic body radiotherapy (SBRT) RADIATION

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.

Men with prostate cancer post-prostatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Royal Victoria Regional Health Centre: collaborator
• Princess Margaret Hospital, Canada: collaborator
• Credit Valley Hospital: collaborator

Study Sites (1)

Sunnybrook Odette Cancer Centre

Toronto, Onatrio, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dr. Chia-Lin Tseng, MD, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor, Dept of Radiation Oncology Sunnybrook Odette Cancer Centre

Model Details: men diagnosed with prostate cancer post-prostatectomy

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: June 3, 2021
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)