NCT06625034RecruitingPhase 3
Radiation Therapy With RapidPlan Knowledge-based Planning vs Human-Driven Planning for Treatment of Prostate Cancer
Randomized Phase III Trial of Rapid-Plan Knowledge-Based Planning vs. Human-Driven Planning for Prostate Cancer Radiotherapy
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 1 Oct 2024
- Start date
- 2 Feb 2025
- Primary completion date
- 28 Mar 2027
- Lead sponsor
- Mayo Clinic
- Diseases
- Prostate cancer
- NCT number
- NCT06625034
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 108
- From 2 Feb 2025 to the primary completion date, 28 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiation \> 5 Gy
- Planned delivery of radiotherapy to pelvic lymph nodes
- Prior hip replacement or penile implant
Other illness
- 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)
- 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)
Other
- Planned delivery of brachytherapy of the prostate
- Indwelling or intermittent urinary catheter use
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Not yet recruiting |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.