Stratagen Quantitative Prostate MRI Platform Pilot Study

Recruiting

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

Who can join

Ages 40 to 90 · Men

Full eligibility 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

About the study

The goal of this clinical trial is to assess the safety and feasibility of the Stratagen Quantitative Prostate MRI Platform when used in addition to the standard scans conducted during the existing prostate MRI sessions.

* What severe problems, if any, occur because of the use of the Stratagen Quantitative Prostate MRI Platform? * Can the data collected be used to measure quantitative MRI parameters?

Participants will:

\- Receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session.

What is being tested

MRI (device)

Sponsor: Stratagen Bio, Inc. · Participants: 75 · Started: Sep 24, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06985238

Locations in the U.S.

New York	Urology Clinic at Sawgrass, Rochester
Virginia	Virginia Urology, Richmond

Conditions

Prostate Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.