RecruitingNot ApplicableNCT05313815

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


Sponsor

University Health Network, Toronto

Enrollment

100 participants

Start Date

Jul 18, 2022

Study Type

INTERVENTIONAL

Conditions

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: MALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria2

  • Prior pelvic radiotherapy.
  • Contraindications to radiotherapy

Interventions

RADIATIONModerate 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


Locations(1)

Princess Margaret Cancer Center

Toronto, Ontario, Canada

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NCT05313815


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