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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)

• Registration Number: NCT05313815
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-06
• Study Start: 2022-07-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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))

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Exclusion Criteria

• Prior pelvic radiotherapy.
• Contraindications to radiotherapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy	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

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	Baseline to 5-year Follow-up	Safety will be evaluated by recording overall mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary).
Patient-reported quality-of-life assessed by EPIC-26	Baseline to 5-year Follow-up	Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)
Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity	Baseline to 5-year Follow-up	Acute (less than or equal to 90 days) and long-term (greater than 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.
Measure of oncologic outcomes	Baseline to 5-year Follow-up	Biochemical control rate will be assessed at baseline and at each follow-up visit (3 weeks after treatment then every 6 months until 5 years or more frequently if clinically necessary) by the blood level of prostate-specific antigen (PSA) levels
Measure the severity of lower urinary tract symptoms during the study	Baseline to 5-year Follow-up	Patient-Reported symptoms will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: International Prostate Symptom Score (IPSS)
Prostate cancer specific survival based on death from prostate cancer	Baseline to 5-year Follow-up	Safety will be evaluated by recording prostate cancer mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary)
Measure of onocologic outcomes	Baseline to 5-year Follow-up	Radiographic control rate will be assess at baseline and weekly during the radiotherapy intervention using cone beam CT or bone scan.

Trial Locations

Locations (1)

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada