NCT07219303

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prostate Cancer (Adenocarcinoma)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-25
• Primary completion: 2033-08-01
• Completion: 2033-11-01
• First posted: 2025-10-21
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States