A Phase 2 interventional study of MRI-guided Intensity-Modulated Radiation Therapy and Antiandrogen Therapy in Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8 and Stage IIIC Prostate Cancer AJCC v8, sponsored by Thomas Jefferson University. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Thomas Jefferson University · Phase 2, Interventional, and Treatment
This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects in patients with high risk prostate cancer. MRI-guided hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time directly to diseased tissue, reducing damage to healthy tissue. Using MRI-guided radiation therapy on areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared to the longer standard of care therapy and may reduce the number and/or duration of side effects.
PRIMARY OBJECTIVE:
I. Evaluate late grade 2+ genitourinary (GU) toxicity.
SECONDARY OBJECTIVE:
I. Evaluating acute GU and gastrointestinal (GI) toxicity, late GI toxicity, overall survival, prostate cancer specific survival, biochemical failure, and quality of life.
OUTLINE:
Patients undergo MRI-guided intensity-modulated radiation therapy (IMRT) on study and receive standard of care (SOC) antiandrogen therapy (ADT) throughout the trial. Patients may also undergo prostate specific membrane antigen (PSMA) positron emission tomography (PET), computed tomography (CT), MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for a total of 4 years.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 6 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
Procedure: MRI-guided Intensity-Modulated Radiation Therapy · Drug: Antiandrogen Therapy · Procedure: PSMA PET Scan · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Procedure: Bone Scan · Procedure: Biospecimen Collection · Other: Quality-of-Life Assessment
Undergo MRI-guided IMRT
Receive SOC ADT
Also known as: ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy
Undergo PSMA PET scan
Also known as: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography
Undergo CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography, CT, CT SCAN, tomography, Computerized axial tomography (procedure)
Undergo MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging, Magnetic resonance imaging (procedure)
Undergo bone scan
Also known as: Bone Scintigraphy
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Ancillary studies
Also known as: Quality of Life Assessment
Rate of late grade 2+ genitourinary (GU) toxicity
Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected.
Time frame: At 1 year
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time frame: At baseline
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time frame: At treatment completion, up to 10 days
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time frame: every 3 months after treatment until 1 year
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time frame: At baseline
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time frame: At treatment completion, up to 10 days
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time frame: every 3 months after treatment until 1 year
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Overall survival
Will be estimated using the Kaplan-Meier method.
Time frame: At baseline
Overall survival
Will be estimated using the Kaplan-Meier method.
Time frame: At treatment completion, up to 10 days
Overall survival
Will be estimated using the Kaplan-Meier method.
Time frame: every 3 months after treatment until 1 year
Overall survival
Will be estimated using the Kaplan-Meier method.
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Time frame: At baseline
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Time frame: At treatment completion, up to 10 days
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Time frame: every 3 months after treatment until 1 year
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Time frame: At baseline
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Time frame: At treatment completion, up to 10 days
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Time frame: every 3 months after treatment until 1 year
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Time frame: every 6 months beginning at year 2, assessed up to 4 years
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Time frame: At baseline
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Time frame: At treatment completion, up to 10 days
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Time frame: every 3 months after treatment until 1 year
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Time frame: every 6 months beginning at year 2, assessed up to 4 years
This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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