Stratagen quantitative prostate MRI platform pilot
A Pilot Study to Determine Safety and Feasibility of the Stratagen Quantitative Prostate MRI Platform as an Adjunct to Standard of Care MRI When Evaluating for Clinically Significant Prostate Cancer
NA · Stratagen Bio, Inc. · NCT06985238
This pilot tests whether adding the Stratagen quantitative MRI scan to routine prostate MRI is safe and can collect useful measurement data for men being considered for prostate biopsy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | Male |
| Sponsor | Stratagen Bio, Inc. (industry) |
| Locations | 2 sites (Rochester, New York and 1 other locations) |
| Trial ID | NCT06985238 on ClinicalTrials.gov |
What this trial studies
This pilot adds up to 15 minutes of extra imaging using the Stratagen quantitative prostate MRI platform to participants' routine prostate MRI sessions to check safety and data quality. Participants are men aged 40–90 with PSA ≥2.5 whose prostates are being considered for biopsy, and those with recent biopsy, pelvic implants, prior prostate therapy, or MRI contraindications are excluded. The study records any severe problems related to the platform and analyzes the images to determine whether quantitative MRI parameters can be derived. Enrollment occurs at two U.S. urology clinics and the extra sequences are performed during participants' scheduled clinical MRI visit.
Who should consider this trial
Good fit: Men aged 40–90 with PSA ≥2.5 whose prostate is being considered for biopsy and who can safely undergo MRI.
Not a fit: People who cannot have MRI, have a recent prostate biopsy, pelvic implants that cause MRI artifact, prior prostate treatments, or are in conflicting investigational studies are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the platform could add quantitative MRI measurements to routine scans that help guide biopsy decisions or monitoring with little extra scan time.
How similar studies have performed: Prior research into quantitative prostate MRI techniques has shown promising ability to measure tissue properties, but commercial platforms and routine clinical use remain under active investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject has a prostate that would be considered for biopsy * Age 40-90 years * PSA ≥ 2.5 * Subject has been informed of the nature of the study and has provided written informed consent Exclusion Criteria: * Contraindication for MRI * Prostate biopsy within the previous 12 weeks * Implant in the pelvis that may cause artifact on MRI (e.g. hip replacement) * History of prostatectomy or other local prostate cancer therapy (e.g., cryotherapy or brachytherapy), or previous pelvic irradiation * Currently enrolled in another investigational drug or device study that clinically interferes with this study * Unable to comply with the study requirements or follow up schedule * Any condition the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject
Where this trial is running
Rochester, New York and 1 other locations
- Urology Clinic at Sawgrass — Rochester, New York, United States (RECRUITING)
- Virginia Urology — Richmond, Virginia, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer