Comparing RapidPlan and human-driven planning for prostate cancer radiation therapy
Randomized Phase III Trial of Rapid-Plan Knowledge-Based Planning vs. Human-Driven Planning for Prostate Cancer Radiotherapy
This study is testing if a new computer-based tool for planning radiation therapy can work as well as traditional methods for prostate cancer patients while causing fewer side effects.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT06625034 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the effectiveness of RapidPlan, a knowledge-based planning tool, against traditional human-driven planning in delivering radiation therapy to prostate cancer patients. The study aims to determine if RapidPlan can achieve similar or fewer adverse effects related to genitourinary and gastrointestinal systems compared to the standard method. Patients will be randomized into two groups, one receiving human-driven planning and the other using RapidPlan, with follow-up assessments at 3 and 12 months post-treatment. The trial also explores quality of life and dose-volume constraints associated with each planning method.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 and older with histologically confirmed prostate cancer at specific clinical stages.
Not a fit: Patients with a history of previous pelvic radiation exceeding 5 Gy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient and potentially safer radiation therapy planning for prostate cancer patients.
How similar studies have performed: While knowledge-based planning is gaining traction, this specific comparison of RapidPlan to human-driven planning is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scottsdale, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Nathan Y. Yu, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.