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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT07219303
Status
Recruiting
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Conditions

  • Prostate Cancer (Adenocarcinoma)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • adaptive stereotactic body radiation therapy (SBRT) with a SIB — RADIATION
    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.

Study Details

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

Key Dates

Start date
Sep 25, 2025
Status verified
Oct 2025
Primary completion
Aug 1, 2033
Completion
Nov 1, 2033

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose escalated adaptive stereotactic body radiation therapy (SBRT) with a SIB

Primary Outcome Measure

Severe (CTCAE grade ≥ 3) treatment-related (possibly, probably or definitely) toxicity occurring within 90 days of treatment. [ Time Frame: From initiation of treatment to 90 days after end of treatment, for a duration of ~100 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Mark A Hallman, MD, PhD
[email protected]
215-728-2581

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By research site
Fox Chase Cancer Center· Philadelphia, PA

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