NCT06985238Active, not recruiting
Stratagen Quantitative Prostate MRI Platform Pilot Study
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
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 22 Apr 2025
- Start date
- 24 Sept 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Stratagen Bio, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT06985238
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 24 Sept 2025 to the primary completion date, 30 Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Contraindication for MRI
- Unable to comply with the study requirements or follow up schedule
Who the study is looking for
- 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
Age in the registry: 40 years to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Urology Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Urology Clinic at Sawgrass Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.