Actively Recruiting
Dose Escalated CT-Based Adaptive Stereotactic Body Radiation Therapy for Intermediate- and Favorable High-Risk Prostate Cancer
Led by Fox Chase Cancer Center · Updated on 2025-10-29
80
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating adaptive stereotactic body radiation therapy (SBRT) as a treatment for adults with intermediate- and favorable high-risk prostate cancer. This study aims to determine the highest safe dose of adaptive SBRT, how well it targets the prostate while reducing radiation to nearby organs, and its effects on side effects and quality of life during and after treatment over a five-year period. Participants will receive adaptive SBRT every other day for a total of 5 treatment sessions, usually completed within 2 to 3 weeks. After treatment, there will be a follow-up phone call at about 6 weeks to check on side effects and wellbeing. Participants will also have clinic visits for tests and check-ups at 90 days post-treatment, then every 3 months for the first year, and every 6 months thereafter. Throughout the study, researchers will assess treatment-related toxicities occurring within 90 days, biochemical progression, local failure, distant metastasis, and PSA response up to 5 years. They will also monitor urinary, bowel, and sexual function changes using EPIC-26 scores at various intervals. Safety monitoring includes evaluating treatment planning criteria and side effects during and after treatment, with participant involvement lasting up to 5 years.
CONDITIONS
Brief 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 edition stage IIA-IIC)
- Age over 18 years
- ECOG performance status of 2 or less
- Prostate volume of 100 cc or less determined by MRI and/or ultrasound within specified timeframes
- Pre-treatment diagnostic multiparametric MRI showing PI-RADS 3, 4, or 5 lesion or a PSMA PET/CT within 12 months before registration
- Baseline International Prostate Symptom Score (IPSS) of 15 or less; baseline alpha blocker use allowed
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Experiencing grade 3 or higher genitourinary or gastrointestinal toxicity at baseline
- Receiving any other investigational agents
- Prior pelvic radiation therapy
- Node-positive disease
- Extraprostatic extension determined by MRI within 24 months before treatment
- Prior ablative therapies for prostate cancer such as cryosurgery, HIFU, or nanoknife
- Prior simple prostatectomy
- Receiving other antineoplastic agents including methotrexate
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues
- Conditions preventing safe delivery of SBRT
- Active inflammatory bowel disease or collagen vascular disorder
- Unable to undergo prostate fiducial or rectal spacer placement
- Unable to undergo prostate MRI
- Bilateral prosthetic hips; unilateral prosthetic hips allowed only if treatment plan meets criteria without violations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Typically completed in 2-3 calendar weeks
Participants receive adaptive stereotactic body radiation therapy (SBRT) with a simultaneous integrated boost (SIB) over 5 fractions every other day.
5 treatment visits every other day
Duration - Up to 5 years
Participants are monitored for treatment-related toxicity and prostate cancer progression for up to 5 years after treatment ends.
Periodic visits for assessments up to 5 years
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
J
Jianli Hu, MD, PhD
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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