Study on Shortened Radiation Therapy for Recurrent or Limited Spread Prostate Cancer

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT04190446

Provider View

This clinical trial is exploring whether a shorter course of radiation therapy, using either proton therapy or IMRT, can effectively treat prostate cancer that has returned or spread to a few areas, with fewer side effects.

Patient Parameters

Program Overview

This study is testing two types of radiation therapy—hypofractionated proton therapy and IMRT—to see how well they work and what side effects they cause in men whose prostate cancer has come back or spread to a limited number of sites after initial treatment. Hypofractionated proton therapy delivers smaller doses over time, which might kill more cancer cells and cause fewer side effects. IMRT uses high-energy x-rays to target and shrink tumors. The goal is to find out if a shorter course of radiation is better for patients with recurrent prostate cancer.

Description

The main goal of this study is to see if there are any serious side effects affecting the stomach or urinary system from the shorter radiation treatment, either with proton therapy or IMRT, within 3 to 24 months after treatment. The study also looks at less severe side effects and compares the two treatment schedules.

Participants are randomly assigned to one of two groups:

  • Group 1: Receives proton beam radiation therapy 5 days a week for 3 weeks. They will have PET scans, CT scans, MRI, and blood tests during the study.
  • Group 2: Receives IMRT 5 days a week for 5 weeks. They will also have PET scans, CT scans, MRI, and blood tests during the study.

After finishing the treatment, participants will have follow-up visits at 3-6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months to monitor their health and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Male, aged 18 years or older
  • Confirmed diagnosis of prostate adenocarcinoma
  • Prostate cancer has returned after initial radiation treatment
  • Cancer has spread to a limited number of lymph nodes, as shown by advanced imaging tests
  • Cancer is limited to pelvic and/or nearby lymph nodes
  • Good overall health with a performance score of 0 or 1
  • Signed informed consent to participate

Exclusion Criteria

  • Cancer has spread to bones or other organs
  • Cancer has spread beyond the pelvis or nearby lymph nodes
  • Cannot have radiation therapy due to certain medical conditions
  • Cannot have hormone therapy
  • Currently receiving chemotherapy
  • Had another cancer (except non-melanoma skin cancer) within the last 5 years
  • Cannot start radiation treatment within 6 months of joining the study
  • Medical or mental health issues that prevent understanding or following the study plan

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

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