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

NCT05313815 · tracked via the Priya Life Science Canada tracker

Sponsor

University Health Network, Toronto

Phase

Not applicable

Started

2022-07-18

Last updated

2026-06-05

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)

Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy): External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes

Study 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.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age \> 18 years. * Able to provide informed consent. * Histologic diagnosis of prostate adenocarcinoma. * ECOG performance status 0-1. * 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

Primary outcome measure(s)

Acute Grade >2 Gastrointestinal Toxicity — 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.

Trial sites (1)

Facility	City	Region	Status
Princess Margaret Cancer Center	Toronto	Ontario	Recruiting

More University Health Network, Toronto trials in Canada

Ted Rogers Understanding of Exacerbations in Heart Failure 2: Monitor Recruiting

Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE) Recruiting

Cabozantinib to Treat Recurrent Liver Cancer Post Transplant Recruiting

Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus Starting soon

CfDNA in Hereditary And High-risk Malignancies 2 Recruiting

Other trials for the same condition

Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer Recruiting

PSMA-PET Directed Radiation Therapy for High-Risk Prostate Cancer Starting soon

Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer Starting soon

Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era Recruiting

Micro-Ultrasound for Detecting Clinically Significant Prostate Cancer in Active Surveillance Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05313815 on ClinicalTrials.gov ↗ ← All trials in Canada