Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer (MOB-RT)

University Health Network, Toronto

Status: Enrolling

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05313815

22-5218

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy

Experimental group

Description:

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

Treatment:

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