MRI Screening for Prostate Cancer

Overseen By Danny Vesprini, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Toronto Sunnybrook Regional Cancer Centre

Disqualifiers: Claustrophobia, MRI contraindication, Prostate cancer, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether MRI scans (referred to as MS3TMRI) can detect prostate cancer earlier in men with a BRCA1 or BRCA2 mutation. These men have a higher risk of aggressive prostate cancer, and standard tests might not detect it early enough. The study compares MRI results to standard screenings like PSA tests and digital rectal exams. Men who have tested positive for BRCA mutations and are willing to undergo a biopsy after an MRI might be suitable participants. This research could determine if MRIs are a more effective method for early detection of prostate cancer in high-risk individuals. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance early detection methods for those at high risk.

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

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

What prior data suggests that MRI screening is safe for detecting prostate cancer in men with BRCA mutations?

Research has shown that using MRI (magnetic resonance imaging) for prostate cancer screening is generally safe. In a study of 216 men over five years, none of the deaths resulted from prostate cancer, suggesting that MRI is a safe tool for screening and monitoring. Another study found that MRI helps doctors detect prostate cancer more accurately, reducing unnecessary procedures.

These studies indicate that patients generally tolerate MRI well as a screening method. No major safety concerns were reported, making MRI a reliable option for early detection of prostate cancer, especially in men at higher risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MS3TMRI technique for prostate cancer detection because it offers a non-invasive alternative to traditional methods like the TRUS-guided biopsy. Unlike the standard biopsy, which is invasive and can sometimes miss cancerous areas, MS3TMRI uses advanced MRI technology to provide detailed imaging of the prostate. This could lead to more accurate detection of cancerous tissues, potentially reducing unnecessary biopsies and improving early diagnosis rates. By enhancing precision in screening, MS3TMRI has the potential to transform how prostate cancer is detected and managed.

What evidence suggests that MRI screening is effective for detecting prostate cancer in men with a BRCA mutation?

Research has shown that MRI scans, such as the MS3TMRI used in this trial, can be very effective for prostate cancer screening. Studies have found that MRI scans can detect more serious prostate cancers earlier while reducing the detection of less serious ones. This method can also help avoid unnecessary biopsies, with evidence indicating that up to 41% of men could skip this invasive procedure without missing cancer. MRI scans have been found to add more quality years to life compared to traditional PSA tests. Overall, MRI screening appears promising for improving early detection, especially for high-risk groups like those with BRCA mutations. Participants in this trial will undergo MS3TMRI screening, and some may also receive a TRUS Guided Biopsy as part of the study protocol. ^{3 6 7 8 9}

Who Is on the Research Team?

Danny J Vesprini, MD, MSc, FRCPC

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for men over 50 who are part of the Male Hereditary Cancer Research Program, have a BRCA1 or BRCA2 mutation, and can undergo an ultrasound biopsy. It's not for those with claustrophobia, MRI contraindications, contrast agent issues, or previous prostate cancer diagnosis.

Inclusion Criteria

Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center

I am 50 years old or older.

I am willing and able to have an ultrasound biopsy within 4 weeks after my MRI.

Exclusion Criteria

Claustrophobia

I cannot have MRI contrast due to a medical reason.

I have been diagnosed with prostate cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Screening

Participants undergo Multispectral 3T MRI to assess its value as a screening tool for prostate cancer

2 years

Regular MRI visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after MRI screening

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MS3TMRI
• TRUS Guided Biopsy

Trial Overview The study tests if using MRI as a screening tool helps detect prostate cancer earlier in men at high risk due to BRCA mutations. This is compared to standard PSA testing and digital rectal examination.

How Is the Trial Designed?

Group I: MS3TMRI / TRUS Guided Biopsy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Toronto Sunnybrook Regional Cancer Centre

Lead Sponsor

Trials

10

Recruited

950+

Women's College Hospital

Collaborator

Trials

108

Recruited

43,700+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39321360/

Results after Four Years of Screening for Prostate Cancer ... In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02799303

MRI Versus PSA in Prostate Cancer Screening Unlike the USPSTF, the ASCO panel placed greater weight on the results of the ERSPC, demonstrating a significant reduction in the risk of prostate cancer death ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9644313/

Prostate MRI versus PSA screening for prostate cancer ... MRI-based prostate cancer screening resulted in more years of life gained and quality-adjusted life-years (QALY) by 3 and 3.5 years per 1000 ...

4. youtube.com youtube.com/watch?v=agcxD8bVYyk

Can MRI Safely Skip Prostate Biopsies? 3-Year Study Results The results? A striking 41% of men avoided biopsies over three years, backed by a 96% negative predictive value (NPV) for clinically ...

5. researchgate.net researchgate.net/publication/379874962_The_impact_of_pre-biopsy_MRI_and_additional_testing_on_prostate_cancer_screening_outcomes_A_rapid_review

(PDF) The impact of pre‐biopsy MRI and additional testing ... Prostate‐specific antigen (PSA)‐based screening led to the increased detection of low‐grade cancer and reduction of advanced/metastatic disease ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01896713

The Value of MultiSpectral 3 Tesla MRI in Active ... Outcome Measure, Measure Description, Time Frame. The number of cores required for diagnosis of prostate cancer for MS3TMRI-TRUSBx versus TRUSBx alone, The ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7443696/

Five-year Outcomes of Magnetic Resonance Imaging–based ... In total, 216 men were treated. There were 24 deaths, none of which was prostate cancer related (6.3/1000 py; 95% CI: 4.1–9.5). Metastases developed in ...

8. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(16)32401-1/fulltext

Diagnostic accuracy of multi-parametric MRI and TRUS ... Over three-quarters of men in PROTECT had low risk disease, exemplifying the problem of over-diagnosis from a TRUS biopsy in all strategy and ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38324313/

A Secondary Analysis of the STHLM3-MRI Randomized ... Main outcomes and measures: The primary outcome was clinically significant prostate cancer (Gleason score of ≥3 + 4). Secondary outcomes ...