Prostate CancerNCT06985238
Stratagen Quantitative Prostate MRI Platform Pilot Study
A study testing MRI in people with Prostate Cancer, run by Stratagen Bio, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Sep 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Urology
Richmond, Virginia, 23235
Urology Clinic at Sawgrass
Rochester, New York, 14620
About this study
Official title: 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
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.
- Conditions
- Prostate Cancer
- Being tested
- MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Will receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session.
| Study group | Role | What they receive |
|---|---|---|
| Stratagen Quantitative Prostate MRI Platform | Experimental | Not described Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines
All serious adverse events attributable to the Stratagen Quantitative Prostate MRI Platform will be reported.
Measured: Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
• 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
Measured: Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start24 Sep 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stratagen Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985238
- Sponsor's protocol ID
- ST-25-001
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06985238
- Acronym / sponsor ID
- ST-25-001
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Stratagen Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stratagen Quantitative Prostate MRI Platform | Experimental | Device: MRI |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIWill receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session. | Device | Stratagen Quantitative Prostate MRI Platform |
Primary outcome
Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines
Time frame: 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
Time frame: Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Prostate Cancer, run by Stratagen Bio, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: no SAEs attributable to the Stratagen Quantitative Prostate MRI Platform, as determined by participating Investigator according to CTCAE guidelines (time frame: Beginning of MRI Scan to end of MRI scan (MRI Scan Visit, Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.