Study Comparing Radiation Therapy Planning Methods for Prostate Cancer Treatment

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06625034

Provider View

This clinical trial is comparing two methods of planning radiation therapy for prostate cancer: a new automated system called RapidPlan and the traditional human-driven planning. The study aims to see if the new method is as effective and safe as the current standard.

Patient Parameters

Program Overview

This study is testing two different ways to plan radiation therapy for prostate cancer. Radiation therapy uses high-energy rays to kill cancer cells. The planning process decides how and where the radiation will be delivered. The new method, RapidPlan, uses a computer program to create a treatment plan automatically, while the traditional method relies on a specialist to do it manually. The study will compare the side effects and effectiveness of both methods to see if RapidPlan can provide similar or better results with fewer side effects.

Description

The main goal of this study is to find out if the RapidPlan method of planning radiation therapy is as good as the traditional human-driven method in terms of side effects related to urinary and digestive systems three months after treatment.

The study will also look at:

  • The occurrence of moderate side effects three months after treatment.
  • The quality of life of patients three months after treatment.
  • How well the treatment plans meet specific radiation dose guidelines.

Participants will be randomly assigned to one of two groups:

  • Group A (Human-Driven Planning): Participants will receive radiation therapy planned by a specialist. They will also have MRI scans, blood tests, and PET scans during the study.

  • Group B (RapidPlan Planning): Participants will receive radiation therapy planned by the RapidPlan system. They will also have MRI scans, blood tests, and PET scans during the study.

After finishing the treatment, participants will have follow-up visits at 3 and 12 months, and then once a year for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of prostate cancer.
  • Cancer stage must be between T1c and T3b, with no spread beyond the prostate or nearby lymph nodes.
  • Plan to receive radiation therapy to the prostate or prostate area.
  • Be in good general health with an ECOG performance status of 0 to 2.
  • Must agree to participate and sign a consent form.
  • Complete all necessary tests before starting the study.
  • Be able to start radiation treatment within 180 days of joining the study.

Exclusion Criteria

  • Have had previous radiation to the pelvic area over 5 Gy.
  • Plan to receive radiation to pelvic lymph nodes.
  • Plan to receive brachytherapy (internal radiation) for the prostate.
  • Have active rectal conditions like diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.
  • Have had a hip replacement or penile implant.
  • Have major medical, psychiatric, or addiction issues that could interfere with the study.
  • Use a urinary catheter regularly.

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