PET/MR Imaging for Prostate Cancer
(PSMA-DOCS Trial)
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.12345Why 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.16789
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
PET/MRI Imaging
All patients undergo PET/MRI after injection of 18F-DCFPyL to detect prostate cancer lesions
Biopsy
Lesions detected on PET/MRI undergo biopsy using fused PET/MRI and ultrasound images for guidance
Follow-up
Participants are monitored for safety and effectiveness after biopsy and imaging
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?
2
Treatment groups
Experimental Treatment
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)
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:
- Detection of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer
- Diagnostic imaging in men with prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Citations
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.
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 ...
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.
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 ...
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 ...
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 ...
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.
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.
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 ...
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