RecruitingNot ApplicableNCT07219303

Adaptive Radiation Therapy for Men With Intermediate- or High-Risk Prostate Cancer

Dose Escalated CT-Based Adaptive Stereotactic Body Radiation Therapy Among Patients With Intermediate- and Favorable High- Risk Prostate Cancer (DE-CART)


Sponsor

Fox Chase Cancer Center

Enrollment

80 participants

Start Date

Sep 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate if adaptive stereotactic body radiation therapy (SBRT) is a safe and effective way to treat prostate cancer in adults. It will assess the safety profile of adaptive SBRT over time. The main questions this trial aims to answer are: * What is highest dose of adaptive SBRT without causing serious side effects? * Can adaptive SBRT more precisely targeting the prostate while reducing radiation exposure to nearby organs? * What side effects do participants experience during treatment, right after treatment, and over the five years post-treatment? * Can adaptive SBRT reduce urination-related side effects and support quality of life during and after treatment? Participants will: * Receive adaptive SBRT treatment every other day, for a total of 5 treatment sessions (called fractions). The full course of treatment typically takes 2 to 3 weeks. * Have a follow-up phone call about 6 weeks after treatment to check on side effects and overall wellbeing. * Visit the clinic for check-ups and tests: * At 90 days (about 3 months) after treatment * Then every 3 months for the first year * Then every 6 months after that


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing adaptive radiation therapy — a form of radiation that is adjusted in real time based on changes in the patient's anatomy — for men with intermediate- or high-risk prostate cancer. Traditional radiation delivers a set plan that doesn't account for daily changes in the body, so this adaptive approach aims to be more precise and reduce side effects. **You may be eligible if...** - You are a man over 18 with confirmed intermediate- or favorable high-risk prostate cancer - Your prostate is not too large (volume of 100 cc or less) - You had a diagnostic MRI showing specific findings, or a PSMA PET scan within the past year - Your urinary symptoms at baseline are manageable (IPSS score of 15 or less) **You may NOT be eligible if...** - You have already received radiation to the pelvis - You have lymph node involvement (node-positive disease) - You have had prior ablative treatments such as cryosurgery, HIFU, or nanoknife for prostate cancer - You have severe urinary or bowel symptoms (CTCAE Grade 3 or higher) - You have extraprostatic extension of the cancer on MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONadaptive stereotactic body radiation therapy (SBRT) with a SIB

This is a phase 1 dose finding study investigating escalated doses of adaptive prostate SBRT for patients with intermediate and favorable high risk prostate cancer. There will be a Bayseian Optimal Interval Design (BOIN) defining the dose escalation parameters and the dose will escalate as per Section 5.0. Treatment is 5 fractions every other day and will be expected to be typically completed in 2-3 calendar weeks.


Locations(1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

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NCT07219303


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