Stratagen Quantitative Prostate MRI Platform Pilot Study

This study is testing a new tool called the Stratagen Quantitative Prostate MRI Platform. It adds up to 15 minutes of extra scanning time to a regular prostate MRI. The main goals are to see if this new platform is safe (meaning no serious problems happen because of it) and if it can successfully collect specific data to create detailed images of the prostate. You might be able to join if you are a man between 40 and 90 years old, have a PSA (Prostate-Specific Antigen) level of 2.5 or higher, and your doctor is considering a prostate biopsy. The study is looking to enroll 75 participants.

Study design: This is an interventional study, meaning participants will receive a specific intervention. It aims to enroll 75 participants.
What's involved: You will receive up to 15 minutes of additional MRI scan time during your existing prostate MRI imaging session.
Compensation: Not stated in the trial record.
Follow-up: Safety and feasibility are measured from the beginning to the end of the MRI scan (MRI Scan Visit, Day 0).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Stratagen Quantitative Prostate MRI Platform Pilot Study

Recruiting

NAAges 40–90InterventionalDevice feasibility

Stratagen Bio, Inc.

~75 participants

Updated 2026-03-06 on ClinicalTrials.gov

What's tested:MRI

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines

Measured over Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)

+1 more outcome measured

Conditions

Prostate Cancer

Where it's being run

2 sites across 2 states

New York1

Virginia1

Who to contact

Austin Jackson

[email protected]

585-275-0126

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelinesBeginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
All serious adverse events attributable to the Stratagen Quantitative Prostate MRI Platform will be reported.
• Feasibility: collection of the data necessary to produce measurable quantitative T1 and T2 relaxation times (milliseconds) maps (images) for at least 80% of pixels fully contained within the prostate for at least 80% of subjectsBeginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)

Trialytics