MRI for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Stratagen Bio, Inc.

Disqualifiers: Prostate biopsy, Pelvic implant, Prostatectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Stratagen Quantitative Prostate MRI Platform is safe and beneficial during prostate scans. Researchers seek to find out if this tool can safely offer additional information about the prostate. Participants will have 15 extra minutes added to their regular MRI scans. This trial suits individuals considering a prostate biopsy with a PSA (prostate-specific antigen) level of 2.5 or higher. As an unphased trial, it provides participants the chance to contribute to innovative research that could improve prostate imaging techniques.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Stratagen Quantitative Prostate MRI Platform is safe?

Research has shown that the Stratagen Quantitative Prostate MRI Platform is safe to use. In past studies, no serious medical problems were linked to this MRI platform, indicating that users did not experience major health issues as a result.

The platform adds up to 15 minutes to the usual MRI scan. This extra time allows for more detailed images, helping doctors see the prostate more clearly. The information collected can measure specific MRI details, providing more precise data about the prostate, which could aid in better diagnosis and treatment planning.

Overall, the Stratagen Quantitative Prostate MRI Platform appears to be well-tolerated without causing serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stratagen Quantitative Prostate MRI Platform because it offers a cutting-edge approach to diagnosing prostate cancer. Unlike traditional methods like biopsies or standard MRIs, this platform provides enhanced imaging that can quantify tumor characteristics with greater precision. This means it could potentially lead to earlier and more accurate detection of prostate cancer, allowing for more personalized treatment plans. The platform's ability to provide detailed assessments without invasive procedures is a game-changer, making the diagnostic process safer and more comfortable for patients.

What evidence suggests that the Stratagen Quantitative Prostate MRI Platform is effective for prostate cancer?

Research has shown that the Stratagen Quantitative Prostate MRI Platform, tested in this trial, could enhance the effectiveness of prostate MRI scans. This platform provides specific numerical data, making the scans clearer and more informative. Previous studies suggest that these numbers may improve the performance of prostate MRI by offering more detailed insights. Currently, the trial is testing whether the platform can be safely and easily integrated into regular MRI procedures. The goal is to determine if it can reliably measure these numbers without causing major issues. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

Men aged 40-90 with a prostate that may need biopsy and a PSA level of at least 2.5 are eligible for this trial. They must understand the study's nature and provide written consent to participate.

Inclusion Criteria

I am between 40 and 90 years old.

* PSA ≥ 2.5

* Subject has been informed of the nature of the study and has provided written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Scan

Participants receive up to 15 minutes of additional MRI scan time during the existing prostate MRI imaging session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the MRI scan

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stratagen Quantitative Prostate MRI Platform

Trial Overview This pilot study is testing the Stratagen Quantitative Prostate MRI Platform, which involves up to an extra 15 minutes of MRI scanning during standard prostate MRI sessions, to see if it's safe and can measure specific MRI parameters accurately.

How Is the Trial Designed?

Group I: Stratagen Quantitative Prostate MRI Platform Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stratagen Bio, Inc.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06985238

Stratagen Quantitative Prostate MRI Platform Pilot Study 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/424bdf58d4ebec79/nct06985238-stratagen-prostate-mri-cancer

Stratagen Quantitative Prostate MRI Platform Pilot Study The goal of this clinical trial is to assess the safety and feasibility of the Stratagen Quantitative Prostate MRI Platform when used in addition...

3. withpower.com withpower.com/trial/phase-prostatic-neoplasms-5-2025-1ef11

MRI for Prostate Cancer · Info for Participants 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11961719/

Quantitative Prostate MRI, From the AJR Special Series on ... Prostate MRI has traditionally relied on qualitative interpretation. However, quantitative components hold the potential to markedly improve performance.

5. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLVspLrShR0lHycw4xMDUxMDA1NFLS0bWEARxMCz0zC3MDSx1DcxMzA1NzMwMQ0FHKSy4xMLO0MDUytlCKBQDBXRRu

Save Selected 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 ...

6. ancora.ai ancora.ai/en/details/NCT06985238

Stratagen Quantitative Prostate MRI Platform Pilot Study The goal of this clinical trial is to assess the safety and feasibility of the Stratagen Quantitative Prostate MRI Platform when used in ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT06985238

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