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

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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)

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)

Trial contacts and locations

1

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Central trial contact

Rachel Glicksman, MD

Data sourced from clinicaltrials.gov

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