Rapid-Plan Knowledge-Based Planning vs. Human-Driven Planning for Prostate Cancer Radiotherapy

Overview

About this study

The purpose of this study is to determine if RapidPlan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) at 3 months post-radiotherapy for prostate cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:
1. Patients must be at least 18 years old.
2. Histologically confirmed prostate cancer.
3. Clinical or pathologic stages T1c-T3b, Nx or N0-1, M0-1 (AJCC Criteria 8th Ed.- appendix II).
4. Planned definitive dose radiotherapy to the prostate or prostate bed.
5. ECOG performance status 0-2 (appendix II) assessed within 90 days of enrollment.
6. Patients must sign IRB approved study specific informed consent.
7. Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
8. Patients must be able to start treatment (radiation) within 120 days of study registration.

Exclusion Criteria:
1. Previous pelvic radiation > 5 Gy
2. Planned delivery of radiotherapy to pelvic lymph nodes
3. Planned delivery of brachytherapy of the prostate
4. 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).
5. History of proximal urethral stricture requiring dilatation.
6. 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).           
7. Indwelling or intermittent urinary catheter use

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/4/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Nathan Yu, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20577058

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