MRI Scans for Prostate Cancer

(PRIME Trial)

Not currently recruiting at 44 trial locations

Overseen By Pramit Khetrapal, MBBS PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University College, London

Disqualifiers: Prior biopsy, Prior treatment, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates whether MRI scans without an injection (biparametric MRI) are as effective as the current standard scans with an injection (multiparametric MRI) in detecting significant prostate cancer. The aim is to determine if the simpler scan is equally effective, potentially making the process easier and more comfortable. Suitable candidates for this trial are men who have been advised they might have prostate cancer and have not yet undergone a biopsy or treatment. As an unphased trial, this study provides an opportunity to contribute to research that could simplify prostate cancer detection for future patients.

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 these MRI techniques are safe for prostate cancer detection?

Research has shown that biparametric MRI (bpMRI) is generally safe and well-tolerated. Studies suggest it reduces MRI scan time from about 40 minutes to just 20, decreasing exposure to potential risks and making it safer for many patients. Notably, bpMRI does not require contrast dye, which can sometimes cause allergic reactions.

For multiparametric MRI (mpMRI), research indicates it is a valuable tool for detecting prostate cancer. Although it involves an injection of contrast dye, major adverse reactions are rare, and most patients do not experience serious side effects.

Both MRI methods effectively diagnose prostate cancer, with bpMRI offering a quicker and potentially safer alternative for those concerned about contrast dye use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MRI scans being explored for prostate cancer because they offer distinct advantages over traditional methods. Biparametric MRI (bpMRI) simplifies the process by eliminating the need for contrast agents, making it less invasive and potentially safer for patients. Meanwhile, Multiparametric MRI (mpMRI) provides a more comprehensive view by combining multiple imaging sequences, which helps in better detecting and characterizing prostate cancer. Both approaches aim to improve accuracy and reduce unnecessary biopsies, offering hope for earlier and more precise diagnosis.

What evidence suggests that this trial's MRI techniques could be effective for detecting prostate cancer?

This trial will compare biparametric MRI (bpMRI) and multiparametric MRI (mpMRI) for detecting prostate cancer. Research has shown that bpMRI is as effective as mpMRI in identifying significant prostate cancer. One study found that bpMRI detected cancer in 84% of cases. Another study confirmed that bpMRI performs as well as mpMRI, with significant cancer found in 29.2% of cases. While mpMRI is well-known for aiding early detection of prostate cancer, bpMRI offers the advantage of not requiring an injection, potentially making the test more comfortable for patients. Both methods are highly effective. ^{1 6 7 8 9}

Who Is on the Research Team?

Caroline Moore, MD FRCS

Principal Investigator

University College, London

Mark Emberton, MD FRCS

Principal Investigator

University College, London

Clare Allen, FRCR

Principal Investigator

University College London Hospital

Shonit Punwani, PhD FRCR

Principal Investigator

University College, London

Francesco Giganti, MD

Principal Investigator

University College, London

Veeru Kasivisvanathan, MBBS PhD

Principal Investigator

University College, London

Are You a Good Fit for This Trial?

This trial is for men over 18 suspected of having prostate cancer, with a PSA level ≤ 20ng/ml, and fit to undergo MRI scans and biopsies. It's not for those who've had previous prostate biopsies or MRIs, have contraindications to MRI or biopsy procedures, or have been treated for prostate cancer before.

Inclusion Criteria

I am a man, 18 or older, suspected to have prostate cancer.

I am physically fit to undergo all required medical procedures.

Able to provide written informed consent

Exclusion Criteria

I cannot undergo a prostate biopsy due to health risks.

You have had a biopsy of your prostate before.

You cannot undergo an MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Assessment

Participants undergo bpMRI and mpMRI to assess the presence of clinically significant prostate cancer

1 week

1 visit (in-person)

Biopsy and Evaluation

Participants with suspicious MRI findings undergo targeted and systematic biopsy

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after MRI and biopsy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biparametric MRI
• Multiparametric MRI

Trial Overview The PRIME study is comparing two types of MRI scans in detecting significant prostate cancer: multiparametric (mpMRI) which uses IV contrast and biparametric (bpMRI) which does not. The goal is to see if bpMRI can match mpMRI's effectiveness without needing contrast.

How Is the Trial Designed?

Group I: bpMRI Experimental Treatment 1 Intervention

Biparametric MRI

Group II: mpMRI Active Control 1 Intervention

Multiparametric MRI

Who Is Running the Clinical Trial?

University College, London

Lead Sponsor

Trials

884

Recruited

38,770,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38830219/

Lifetime Health and Economic Outcomes of Biparametric ... Results of base-case analysis: For 1000 men, first-line bpMRI versus first-line PSA testing prevented 2 to 3 PCa deaths and added 10 to 30 life- ...

2. academic.oup.com academic.oup.com/bjs/article/112/Supplement_10/znaf128.712/8165155

95 Biparametric MRI Scan Effectiveness in Prostate Cancer ... Overall prostate cancer detection rate was 84% (n=86). In PIRADS 5 lesions, 92% of biopsies were positive (n=47), 73% of PIRADS 4 biopsies were ...

3. oncology-central.com oncology-central.com/millions-could-benefit-from-faster-biparametric-mri-scan-for-prostate-cancer/

Millions could benefit from faster biparametric MRI scan for ... The PRIME trial confirms that a biparametric MRI scan is just as effective at diagnosing prostate cancer as a multiparametric MRI.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352047725000024

Ultra-fast biparametric MRI in prostate cancer assessment The purpose of this study is therefore to compare the diagnostic performance and image quality of an ultra-fast bpMRI to the conventional full mpMRI of the ...

5. urologytimes.com urologytimes.com/view/biparametric-mri-is-noninferior-to-multiparametric-mri-for-prostate-cancer-diagnosis

Biparametric MRI is noninferior to multiparametric ... Data showed that biparametric MRI was noninferior to multiparametric MRI. Overall, clinically significant prostate cancer was detected in 29.2% ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S030228382402640X

Evaluating Biparametric Versus Multiparametric Magnetic ... Our results demonstrate that biparametric MRI (bpMRI) is noninferior to multiparametric MRI (mpMRI) in diagnosing clinically significant prostate cancer, as ...

7. renalandurologynews.com renalandurologynews.com/news/biparametric-mri-prostate-cancer-treatment-risk-diagnosis/

Trial Proves Biparametric MRI Is Accurate for Prostate ... Using biparametric MRI can reduce MRI scan time from approximately 40 minutes to 20 minutes, leading to more efficient scan use, less toxicity ...

8. link.springer.com link.springer.com/article/10.1007/s00330-025-11837-1

Diagnostic accuracy of abbreviated biparametric MRI for ... Clinical relevance Prostate MRI may improve cancer detection independently of PSA testing, with abbreviated protocols enhancing feasibility and ...

9. cureus.com cureus.com/articles/388886-a-report-on-the-use-of-biparametric-mri-in-prostate-cancer-diagnosis-a-two-year-single-centre-experience

A Report on the Use of Biparametric MRI in Prostate ... It is effective in detecting clinically significant prostate cancers at a lower cost and shorter time while eliminating the potential harm of ...