Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: stereotactic body radiotherapy (SBRT)

• Registration Number: NCT04848909
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

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 patients are being referred post-operatively for radiotherapy, which creates an added burden on radiotherapy departments. Therefore, a strategy that could potentially decrease the number of radiotherapy fractions, yet maintain its efficacy, would be highly desirable for patient convenience, cost saving, and resource utilization as long as the toxicity profile is acceptable. This study will be conducted to asses the toxicity and efficacy of Stereotactic body radiotherapy (SBRT) in post-prostatectomy patients.

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-15
• Study First Posted: 2021-04-19
• Study Start: 2021-06-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2034-12
• Study Completion: 2034-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Men with prostate cancer post-prostatectomy	stereotactic body radiotherapy (SBRT)	Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Late Adverse Events/toxicities experienced by Participants	6.5 years	Incidence of late GU and GI toxicities (≥6 months) using CTCAE v5.0
Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire	6.5 years	Acute and late GU and GI quality of life (QoL) using the Expanded Prostate Cancer Index Composite questionnaire which evaluates participant's function and bother after prostate cancer treatment. Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.
Health Utilities using The Patient-Oriented Prostate Utility Scale	6.5years	Health utilities using The Patient-Oriented Prostate Utility Scale to measure health-related quality of life, whether it improves, deteriorates or stay the same. There are 10 questions, each questions has 5 possible answers, with 1 being the better outcome and 5 being the worst outcome.
Health Utilities using EuroQol- 5 Dimension Questionnaire	6.5years	Health utilities using the EuroQol- 5 Dimension Questionnaire determines 5 variables, each with 5 possible options, with the first being the best outcome and the last being the worst outcome. The 5 variables include: 1. Mobility; 2. Self-care; 3. Usual Activities; 4. Pain/discomfort; 5. Anxiety/depression
Biochemical disease-free survival	6.5 years	Biochemical disease-free survival (bDFS), defined as survival until first evidence of either biochemical progression (PSA of 0.4 ng/mL or greater) following postoperative radiotherapy, PSA of more than 2.0 ng/mL at any time after postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol hormone therapy, or death from prostate cancer

Trial Locations

Locations (1)

Sunnybrook Odette Cancer Centre; 🇨🇦 Toronto, Onatrio, Canada