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Procedure

Radiation Therapy Planning for Prostate Cancer

Phase 3

Waitlist Available

Led By Nathan Y. Yu, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned definitive dose radiotherapy to the prostate or prostate bed

Clinical or pathologic stages T1c-T3b, Nx or N0-1, M0-1 (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed])

Must not have

Planned delivery of brachytherapy of the prostate

Planned delivery of radiotherapy to pelvic lymph nodes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months post-radiotherapy

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial compares using a computer-based planning system called RapidPlan to plan radiation therapy for prostate cancer patients, versus the traditional method which involves human-driven planning. The computer-based system automatically creates a treatment plan

Who is the study for?

This trial is for individuals with prostate cancer. Participants must be suitable for radiation therapy and willing to undergo various imaging procedures like MRI and PET scans, as well as provide biospecimens. Specific details about inclusion or exclusion criteria are not provided.

What is being tested?

The study compares two methods of planning radiation therapy: RapidPlan knowledge-based planning versus traditional human-driven planning. The goal is to see if the new RapidPlan method can match or reduce side effects compared to the standard approach.

What are the potential side effects?

Potential side effects from radiation therapy may include skin changes, fatigue, urinary issues, bowel problems, and sexual dysfunction. It's unclear if there's a difference in side effects between the two planning methods; this is what the trial aims to find out.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for targeted radiation therapy to my prostate or the area where my prostate was.

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My breast cancer is at a specific stage according to AJCC criteria.

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I am 18 years old or older.

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My prostate cancer diagnosis was confirmed through a tissue examination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for internal radiation therapy for prostate cancer.

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I am scheduled for radiation therapy targeting my pelvic lymph nodes.

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I have received more than 5 Gy of radiation to my pelvis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months post-radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months post-radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months post-radiotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events (AEs)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (RapidPlan treatment planning, radiation therapy)Experimental Treatment6 Interventions

Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.

Group II: Arm A (human-driven treatment planning, radiation therapy)Active Control6 Interventions

Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180