Actively Recruiting
Adaptive Radiation Therapy for Men With Intermediate- or High-Risk Prostate Cancer
Led by Fox Chase Cancer Center · Updated on 2025-10-29
80
Participants Needed
1
Research Sites
422 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Adaptive Radiation Therapy for Men With Intermediate- or High-Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed intermediate- and favorable high-risk adenocarcinoma of the prostate (AJCC 8th ed stage IIA-IIC)
- Age over 18 years
- ECOG performance status 2 or less
- Prostate volume 100 cc or less by MRI or ultrasound within 24 months if not on ADT, or within 6 months if on ADT
- Pre-treatment diagnostic multiparametric MRI showing PI-RADS 3, 4, or 5 lesion or 68Ga-/18F-PSMA PET/CT within 12 months
- Baseline International Prostate Symptom Score (IPSS) of 15 or less; alpha blocker use allowed
- Ability to understand and sign informed consent
You will not qualify if you...
- Current grade 3 or higher genitourinary or gastrointestinal toxicity at baseline
- Receiving other investigational agents
- Prior pelvic radiation therapy
- Node-positive prostate cancer
- Extraprostatic extension by MRI within 24 months; for ADT patients MRI must be before ADT start
- Prior ablative therapies for prostate cancer such as cryosurgery, HIFU, or nanoknife
- Prior simple prostatectomy; prior TURP or laser enucleation allowed
- Receiving other antineoplastic agents like methotrexate
- Prior ADT over 6 months ago with testosterone recovered to at least 100 ng/dL allowed
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, psychiatric illness limiting compliance
- Any condition preventing safe delivery of SBRT as judged by physician
- Active inflammatory bowel disease or collagen vascular disorder
- Unable to undergo prostate fiducial marker placement
- Unable to have rectal spacer placement (iodine contrast preferred; non-contrast allowed if allergic)
- Unable to undergo prostate MRI
- Bilateral prosthetic hips; unilateral hips allowed if treatment plan meets requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
M
Mark A Hallman, MD, PhD
CONTACT
J
Jianli Hu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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