Recruiting
Phase 3

Radiation Therapy vs. Human-Driven Planning

Sponsor:

Mayo Clinic

Code:

NCT06625034

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Magnetic Resonance Imaging

Photon Beam Radiation Therapy

Positron Emission Tomography

Questionnaire Administration

Study Details

Brief summary:

This phase III trial compares the effects of radiation therapy using RapidPlan, trademark, knowledge-based planning to human-driven planning in treating patients with prostate cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Successful delivery of radiation requires planning to develop a treatment plan for how and where the radiation is to be delivered. RapidPlan is a knowledge-based treatment planning tool that automatically creates an optimal treatment plan based on identified targets and organs at risk for radiation exposure. Human-driven treatment planning by a dosimetrist, the current standard of care, requires significant resources and time and may vary within and among radiation centers. Giving radiation therapy with RapidPlan knowledge-based planning may have similar or less side effects compared to human-driven planning in treating patients with prostate cancer.

Conditions

Prostate Carcinoma

Study ID

NCT06625034

Start date

Feb 2, 2025

Status verified date

Jun, 2026

Completion date

May 28, 2033

Anticipated

Primary completion date

May 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must be at least 18 years old
  • Histologically confirmed prostate cancer
  • Clinical or pathologic stages T1c-T3b, Nx or N0-1, M0-1 (American Joint Committee on Cancer \[AJCC\] criteria 8th edition \[Ed\])
  • Planned definitive dose radiotherapy to the prostate or prostate bed
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment
  • Patients must sign Institutional Review Board (IRB) approved study specific informed consent
  • Patients must complete all required pre-entry tests within the specified time frames
  • Patients must be able to start treatment (radiation) within 180 days of study registration
  • In case of confusion about the eligibility or ineligibility of an individual patient, the principal investigator (PI) can be used as the arbiter and a note to file will be added to the subject's regulatory binder to document outcome

Exclusion Criteria:

  • Previous pelvic radiation > 5 Gy
  • Planned delivery of radiotherapy to pelvic lymph nodes
  • Planned delivery of brachytherapy of the prostate
  • Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
  • Prior hip replacement or penile implant
  • Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (consent by legal authorized representative is not permitted for this study)
  • Indwelling or intermittent urinary catheter use

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A (human-driven treatment planning, radiation therapy)

Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.

experimental: Arm B (RapidPlan treatment planning, radiation therapy)

Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.

Interventions

Biospecimen Collection

Undergo blood sample collection

Magnetic Resonance Imaging

Undergo MRI

Photon Beam Radiation Therapy

Undergo radiation therapy

Positron Emission Tomography

Undergo PET

Questionnaire Administration

Ancillary studies

Radiation Therapy Treatment Planning and Simulation

Receive human-driven treatment planning

Radiation Therapy Treatment Planning and Simulation

Receive RapidPlan treatment planning

Primary outcome measure

  • Incidence of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events (AEs) [ Time Frame: Up to 3 months post-radiotherapy ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Cancer Clinical Trials Referral Office

507-293-6386

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Cancer Clinical Trials Referral Office

507-293-6386

Principal Investigator:

Nathan Y. Yu, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-18.