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RECRUITING
NCT07219303
NA

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

Sponsor: Fox Chase Cancer Center

View on ClinicalTrials.gov

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

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-09-25

Completion Date

2033-11-01

Last Updated

2025-10-29

Healthy Volunteers

No

Interventions

RADIATION

adaptive 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