Comparing RapidPlan and human-driven planning for prostate cancer radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Not yet 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.