Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Early Adverse Events/toxicities experience by Participants
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Chia-Lin (Eric) Tseng
Principal Investigator, Assistant Professor, Dept of Radiation Oncology Sunnybrook Odette Cancer Centre
Sunnybrook Health Sciences Centre
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Early Adverse Events/toxicities experience by Participants
Time Frame: 6.5 years
Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Secondary Outcomes
- 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)
- Health Utilities using The Patient-Oriented Prostate Utility Scale(6.5years)
- Health Utilities using EuroQol- 5 Dimension Questionnaire(6.5years)
- Biochemical disease-free survival(6.5 years)