Prostate CarcinomaNCT07859722
CT- Versus MRI-Based Planning for High-Dose-Rate Prostate Brachytherapy for Prostate Cancer
A study testing Magnetic Resonance Imaging and Questionnaire Administration in people with Prostate Carcinoma and Stage I Prostate Cancer AJCC v8, run by Emory University at 3 sites in United States.
Trial summary
This clinical trial studies the safety of a computed tomography (CT) scan, with or without a magnetic resonance imaging (MRI) scan, in planning for high-dose-rate (HDR) prostate brachytherapy treatment in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
- What is being tested?
- Magnetic Resonance Imaging and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Nov 2026to 31 May 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥ 18 years old
- Histopathologically confirmed prostate cancer
- No evidence of regional or distant metastases
- Plan to undergo curative-intent HDR brachytherapy with or without external beam radiation therapy
Who cannot join
- Prior pelvic radiation therapy
- No prior prostate MRI
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Emory Proton Therapy Center
Atlanta, Georgia, 30308
Ardith DeShay, 404-251-0743, ardith.deshay.deshay@emory.edu
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Ardith Deshay, 404-251-0743, ardith.deshay.deshay@emory.edu
Kamran Salari, MD
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Ardith Deshay, 404-251-0743, ardith.deshay.deshay@emory.edu
Kamran Salari, MD
About this study
Official title: A Randomized Pragmatic Study of CT- Versus MRI-Based Planning for High-Dose-Rate Prostate Brachytherapy for Prostate Cancer
This clinical trial studies the safety of a computed tomography (CT) scan, with or without a magnetic resonance imaging (MRI) scan, in planning for high-dose-rate (HDR) prostate brachytherapy treatment in patients with prostate cancer. Brachytherapy is a type of radiation therapy in which radioactive implants, such as pellets, seeds, ribbons, wires, needles, balloons, or capsules, are placed in the body, directly into or near the tumor. The radiation is delivered through a flexible tube called a catheter or a larger device called an applicator. Treatment planning, or simulation, is a process used to plan radiation therapy so that the target area is precisely located and marked. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. An MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. The addition of MRI to CT for HDR prostate brachytherapy treatment planning may help patients have less urine leakage and less pain after treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare acute changes in patient reported outcomes of urinary toxicity utilizing the Expanded Prostate Cancer Index Composite-26 (EPIC-26) Urinary Incontinence domain scores for patients undergoing prostate HDR brachytherapy planned with the utilization of an MRI versus no MRI.
SECONDARY OBJECTIVES:
- To compare acute and chronic changes in patient reported outcomes of toxicity utilizing the EPIC-26 Urinary Irritative/Obstructive, Bowel, and Sexual domain scores for patients undergoing prostate HDR brachytherapy planned with the utilization of an MRI versus no MRI.
II. To compare the cumulative incidence of physician reported Common Terminology Criteria for Adverse Events (CTCAE) acute and chronic grade 2+ genitourinary (GU) or gastrointestinal (GI) toxicity for patients undergoing prostate HDR brachytherapy planned with utilization of an MRI versus no MRI.
TERTIARY/EXPLORATORY OBJECTIVE:
- To compare treatment efficacy for patients undergoing prostate HDR brachytherapy planned with the utilization of an MRI versus no MRI.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo treatment planning with a CT scan for HDR brachytherapy.
ARM B: Patients undergo treatment planning with a CT scan and MRI scan for HDR brachytherapy.
After completion of study intervention, patients are followed up at 1, 3, 6, and 12 months.
- Conditions
- Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Being tested
- Magnetic Resonance Imaging, Questionnaire Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI scan
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (CT, SOC HDR brachytherapy) | Experimental | Patients undergo treatment planning with a CT scan for HDR brachytherapy. Receives: Other: Questionnaire Administration |
| Arm B (CT, MRI, SOC HDR brachytherapy) | Experimental | Patients undergo treatment planning with a CT scan and MRI scan for HDR brachytherapy. Receives: Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) Urinary Incontinence domain score
The primary analysis will be conducted using a mixed-effects model for repeated measures (MMRM) including fixed effects for treatment arm, categorical time, treatment-by-time interaction, baseline Expanded Prostate Cancer Index Composite-26 (EPIC-26) urinary incontinence score, age, comorbidity status, and the stratification factors of high-dose-rate treatment approach and rectal spacer use. EPIC-26 scores range 0-100 with higher scores meaning improved function or lower symptom bother. The primary treatment comparison will be the adjusted between-group difference at the 1-month time point derived from the treatment-by-time interaction using least-squares means, with corresponding two-sided 95% confidence intervals and p-values evaluated at a significance level of 0.05.
Measured: At 1 month following treatment
Secondary outcomes (3)
Mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) Urinary Incontinence domain score
Longitudinal analyses of Expanded Prostate Cancer Index Composite-26 (EPIC-26) urinary incontinence scores will be conducted using MMRM models analogous to the primary analysis, including the stratification factors as covariates. Adjusted mean scores and between-group differences at each time point will be reported with 95% confidence intervals. EPIC-26 scores range 0-100 with higher scores meaning improved function or lower symptom bother.
Measured: At 3, 6 and 12 months following treatment
Mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) Urinary Irritative/Obstructive, Bowel, and Sexual domain scores
Longitudinal analyses of Expanded Prostate Cancer Index Composite-26 (EPIC-26) urinary irritative/obstructive, bowel, and sexual domain scores will be conducted using MMRM models analogous to the primary analysis, including the stratification factors as covariates. Adjusted mean scores and between-group differences at each time point will be reported with 95% confidence intervals. EPIC-26 scores range 0-100 with higher scores meaning improved function or lower symptom bother.
Measured: At 1, 3, 6 and 12 months following treatment
Cumulative incidence of grade 2 or higher genitourinary or gastrointestinal adverse events
Will be analyzed using competing-risk methods to account for death as a competing event. Cumulative incidence functions will be estimated for each treatment arm and compared using Gray's test. Fine-Gray subdistribution hazard models, including stratification factors and relevant covariates, will be used to estimate adjusted hazard ratios with 95% confidence intervals. Adverse events will be coded using the Medical Dictionary for Regulatory Activities and graded according to Common Terminology Criteria for Adverse Events version 5.0. Safety analyses will summarize the frequency, severity, and relationship of adverse events to study treatment by System Organ Class and preferred term. Each adverse event will be counted once per participant at the maximum severity grade. Serious adverse events and events leading to treatment discontinuation will be summarized separately.
Measured: Within 12 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kamran Salari, Emory University
- Investigators
- Kamran Salari, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859722
- Sponsor's protocol ID
- 2026P000571
- Other IDs
- P30CA138292, NCI-2026-06309, 2026P000571, RAD6975-26
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No