Clinical trial · Observational
Prostate Assessment with Restriction Spectrum Imaging (RSI) MRI
Quantitative Diffusion MRI for Prostate Cancer Detection and Monitoring
NCT04992728CI-TRIAL-00085599recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This single-center study will enroll 40 male participants to complete 2 diffusion magnetic resonance images within 30 days of each other.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Restricted Spectrum Magnetic Resonance Imagining | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Male Prostate Patients
- description
- Adult male patients with fair to good performance status and who (1) have undergone an MRI of the prostate for suspected or known prostate cancer and/or (2) are planning to undergo radical prostatectomy for prostate cancer.
- interventionNames
- Other: Restricted Spectrum Magnetic Resonance Imagining
Primary outcomes (1)
- measure
- Detection of grade group ≥2 prostate cancer on histopathology
- timeFrame
- 30 days
- description
- To determine an optimal quantitative dMRI technique for csPCa detection, we will implement an expanded dMRI protocol that will permit exploration of six different approaches, each with published evidence of advantages over conventional ADC. Accuracy will be evaluated using histopathology as the gold standard.
Secondary outcomes (1)
- measure
- Inter-scan reliability
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate * Has already undergone prostate MRI and/or scheduled to undergo clinically indicated radical prostatectomy (to permit whole-mount histopathology correlation). * Intended treatment and follow-up according to standard of care for prostate cancer * In good general health as evidenced by medical history and ECOG performance status 0-2 * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy) * Hip prosthesis * Contraindication to MRI, per institutional requirements * Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.