PET/MR Imaging for Prostate Cancer

(PSMA-DOCS Trial)

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Mr contraindication, Gadolinium contraindication, 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 aims to determine if a new imaging technique, PET-MRI, can better detect significant prostate cancer tumors compared to MRI alone. PET-MRI combines two types of scans to provide more detailed images, potentially revealing tumors that traditional biopsies might miss. Participants will receive a special imaging agent, 18F-DCFPyL (a radioactive tracer), to help highlight any tumors during the PET-MRI scan. The trial seeks men who might have prostate cancer but had negative biopsy results, show signs of more aggressive cancer, or are considering less invasive tumor treatments. The goal is to improve personalized treatment by accurately identifying significant tumors. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance prostate cancer detection and treatment.

Will I have to stop taking my current medications?

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 this PET/MRI technique is safe for detecting prostate cancer?

Research shows that combining MRI and ultrasound for prostate biopsies can more effectively detect significant prostate cancer. Studies confirm that this method is safe and generally well-tolerated by patients, successfully identifying important cancer cases without adding much risk.

Additionally, researchers are exploring the use of PET/MRI with a special radioactive tracer called 18F-DCFPyL to detect prostate cancer more accurately. Early studies demonstrated that this tracer effectively identifies cancer. Although extensive safety data on 18F-DCFPyL is not yet available, combining PET and MRI has a strong track record for finding cancer with few side effects.

In summary, using PET and MRI with ultrasound guidance appears to be a safe and effective way to detect prostate cancer. Previous research has positively received this method, viewing it as a promising tool for improving cancer diagnosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial involving the use of PET/MR imaging combined with 18F-DCFPyL for prostate cancer diagnosis because it offers a more precise technique for identifying suspicious areas within the prostate. Unlike traditional imaging methods, this approach integrates the anatomical detail of MRI with the molecular insights of PET scans, potentially improving the accuracy of prostate cancer detection. Additionally, 18F-DCFPyL is a radiotracer that specifically targets prostate-specific membrane antigen (PSMA), which is often overexpressed in prostate cancer cells, allowing for more targeted biopsies. This could lead to fewer unnecessary biopsies and more tailored treatment plans for patients.

What evidence suggests that PET/MR imaging is effective for detecting prostate cancer?

Research has shown that PET/MRI scans using a special radioactive substance called 18F-DCFPyL can more effectively detect prostate cancer. This method is both sensitive and specific, accurately identifying prostate cancer when present. In this trial, participants with a suspicious focal finding on PET/MR will undergo a PET/MR-ultrasound guided fusion biopsy, which studies have shown to detect more significant tumors than traditional methods. For instance, one study found that this combined method resulted in a higher number of positive biopsy results. This suggests that PET/MRI can be a powerful tool for identifying prostate cancer, potentially detecting tumors that other methods might miss. Participants with no focal findings on PET/MR will undergo a systemic TRUS guided biopsy as per standard care. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men suspected of having prostate cancer who've had negative systematic biopsies, those diagnosed with low-risk disease but showing signs of a more aggressive tumor, or candidates for minimally-invasive tumor ablation needing confirmation of the tumor's extent.

Inclusion Criteria

I am suspected to have prostate cancer despite a negative biopsy or my low-risk cancer might be more serious.

Potential candidates for FT (as per institutional guidelines).

Participants must meet one of the following requirements:

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET/MRI Imaging

All patients undergo PET/MRI after injection of 18F-DCFPyL to detect prostate cancer lesions

1 day

1 visit (in-person)

Biopsy

Lesions detected on PET/MRI undergo biopsy using fused PET/MRI and ultrasound images for guidance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after biopsy and imaging

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL
• PET/MR-ultrasound guided Fusion biopsy
• Systemic TRUS guided biopsy

Trial Overview The study tests if PET/MRI scans using a radioactive probe called '18F-DCFPyL' can better detect clinically significant prostate cancers compared to MRI alone. Detected lesions will be biopsied using image guidance to confirm accuracy.

How Is the Trial Designed?

Group I: No focal biopsy needed Experimental Treatment 1 Intervention

Patients in which PET/MR have found no focal findings, will undergo a systemic biopsy as per standard of care, without specific cores for study purposes (Systemic TRUS guided biopsy)

Group II: Focal biopsy Experimental Treatment 1 Intervention

Patients with a suspicious focal finding on PET/MR, will undergo systemic+focal or focal fusion biopsy (PET/MR-ultrasound guided Fusion biopsy)

18F-DCFPyL is already approved in United States, European Union for the following indications:

Approved in United States as PyL-PSMA-11 for:

• Detection of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

Approved in European Union as 18F-DCFPyL for:

• Diagnostic imaging in men with prostate cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4928379/

Magnetic Resonance Imaging-Ultrasound Fusion-Guided ... Implementation of fusion-guided prostate biopsy has now been proven to improve the detection of clinically significant PCa in appropriately selected patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7456174/

68Ga-PSMA PET/CT Combined with PET/Ultrasound ... Overall, the percentages of total positive cores for targeted biopsy and systematic biopsy were 47.0% (31/68) and 19.4% (72/372), respectively. Extrapolating ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214388224001206

Comparison between 18F-DCFPyL PET/MRI-guided ... The 18 F-DCFPyL PET/MRI-guided ultrasound fusion TB alone was an efficient modality in diagnosing selected patients with prostate cancer.

4. jnm.snmjournals.org jnm.snmjournals.org/content/57/7/1065

The Additional Value of PET for MRI-Guided Transrectal ... Conclusion: Fusion PET/MRI transrectal ultrasound image registration for targeted prostate biopsies is clinically feasible and accurate. The ...

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.612157/full

A Pilot Study of 18 F-DCFPyL PET/CT or PET/MRI and ... MRI/US fusion-guided prostate biopsy allows for equivalent cancer detection with significantly fewer needle cores in biopsy-naive men. Diagn ...

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2827887

Oncological Safety of MRI-Informed Biopsy Decision ... This study demonstrates the high negative predictive value of prebiopsy MRI, showing that men with negative MRI results may not be at an elevated risk for ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2472630324000669

Feasibility and safety study of advanced prostate biopsy ... The study utilized an advanced prostate biopsy robot system based on MR-TRUS image flexible registration technology and conducted experiments on animal models.

8. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.1025355/full

Safety profile of robotic-assisted transperineal MRI-US- ... Robotic-assisted transperineal MRI-US-fusion guided biopsy of the prostate performed under general anesthesia is a safe and well tolerated procedure.

9. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.204066

Safety and Diagnostic Yield of 68 Ga Prostate-specific ... Transgluteal prostate-specific membrane antigen (PSMA) PET/CT-guided, robotic-targeted prostatic biopsy is safe with a high diagnostic yield of prostate cancer ...