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

NCT07219303 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-10-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Mark A Hallman, MD, PhD · FCCC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-25
Primary Completion
2033-08-01
Completion
2033-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07219303 on ClinicalTrials.gov