NCT06625034 Radiation Therapy With RapidPlan Knowledge-based Planning vs Human-Driven Planning for Treatment of Prostate Cancer
| NCT ID | NCT06625034 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mayo Clinic |
| Condition | Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2025-02-02 |
| Primary Completion | 2028-05-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 108 participants in total. It began in 2025-02-02 with a primary completion date of 2028-05-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Nathan Y. Yu, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT06625034 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06625034 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 108 participants.
Is NCT06625034 currently recruiting?
Yes, NCT06625034 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06625034 trial being conducted?
This trial is being conducted at Scottsdale, United States.
Who is sponsoring the NCT06625034 clinical trial?
NCT06625034 is sponsored by Mayo Clinic. The principal investigator is Nathan Y. Yu, MD at Mayo Clinic. The trial plans to enroll 108 participants.