Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer

University Health Network, Toronto1 site in 1 country100 target enrollmentJuly 18, 2022

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: University Health Network, Toronto
Enrollment: 100
Locations: 1
Primary Endpoint: Acute Grade >2 Gastrointestinal Toxicity
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.

Registry

clinicaltrials.gov

Start Date

July 18, 2022

End Date

July 2030

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years.
•Able to provide informed consent.
•Histologic diagnosis of prostate adenocarcinoma.
•ECOG performance status 0-
•High-risk localized disease by NCCN criteria (\>cT3, Grade group \>4, or PSA \>20 ng/mL) or clinical N1 disease.
•Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))

Exclusion Criteria

•Prior pelvic radiotherapy.
•Contraindications to radiotherapy

Outcomes

Primary Outcomes

Acute Grade >2 Gastrointestinal Toxicity

Time Frame: Baseline to 5-year follow-up

Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Secondary Outcomes

Overall survival(Baseline to 5-year Follow-up)
Patient-reported quality-of-life assessed by EPIC-26(Baseline to 5-year Follow-up)
Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity(Baseline to 5-year Follow-up)
Measure of oncologic outcomes(Baseline to 5-year Follow-up)
Measure the severity of lower urinary tract symptoms during the study(Baseline to 5-year Follow-up)
Prostate cancer specific survival based on death from prostate cancer(Baseline to 5-year Follow-up)
Measure of onocologic outcomes(Baseline to 5-year Follow-up)