Status:
RECRUITING
Stratagen Quantitative Prostate MRI Platform Pilot Study
Lead Sponsor:
Stratagen Bio, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
40-90 years
Phase:
NA
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 pr...
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
Key Trial Info
Start Date :
September 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06985238
Start Date
September 24 2025
End Date
October 31 2026
Last Update
October 21 2025
Active Locations (1)
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1
Urology Clinic at Sawgrass
Rochester, New York, United States, 14620