Stratagen Quantitative Prostate MRI Platform Pilot Study

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06985238
• Lead Sponsor: Stratagen Bio, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-22
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Study Start: 2025-06-01
• Primary Completion: 2025-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines	Beginning 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 subjects	Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)