5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5

• Registration Number: NCT04245670
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-31
• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Primary Completion: 2021-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5	Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5	Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

Primary Outcome Measures

Name	Time	Method
Acute Toxicity	Baseline to 3 months post completion of treatment	To document the acute bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria

Secondary Outcome Measures

Name	Time	Method
Economic analysis	Baseline to end of 5 year follow up	Cost effectiveness of treatment.Quality of life and cost estimates will be captured for each patient from time of the initiation of treatment until death. The effectiveness endpoints will be biochemical disease free survival and quality-adjusted life years (QALYs). QALY will be calculated by survival (in years) multiplied by a utility weight associated with a certain condition.
Quality of Life outcome	Baseline to end of 5 year follow up	Measuring quality of life using Expanded Prostate Index Composite (EPIC)
Biochemical disease-free survival	Baseline to end of 5 year follow up	Biochemical disease-free survival
Quality of life outcome	Baseline to end of 5 year follow up	Health utilities using PORPUS-U Quality of Life Questionnaire tool

Trial Locations

Locations (1)

Sunnybrook Health Sciences Center; 🇨🇦 Toronto, Ontairo, Canada