NCT03149861Completed
Detection of Clinically Significant Prostate Cancer With 18F-DCFPyL PET/MR
Source: ClinicalTrials.gov · Last updated 25 Jun 2025
Brief summary (registry, in English)
Background: Currently, patients suspected of having prostate cancer undergo ultrasound-guided systematic biopsies of the prostate. However, up to a quarter of clinically significant tumors, which may pose a risk to patient's well-being, may be missed on random biopsies. MRI enables detection of further tumors in this patient population, but also has limited accuracy. Study hypothesis: We hypothesize that hybrid PET-MRI, a novel scanner which incorporates MRI with molecular imaging will improve the detection rate of clinically significant tumors. Study design: In this prospective trial, we will recruit 57 men who are suspected of having prostate cancer but have had negative systematic biopsies, who have been diagnosed with low-risk disease but have clinically signs of more aggressive tumor or who have a focal tumor detected and are candidates for minimally-invasive tumor ablation (=tumor destruction with laser or ultrasound waves), in whom it is crucial to exclude other tumor sites. All patients will undergo PET/MRI after injection of a radiopharmaceutical called "18F-DCFPyL". This is a radioactive probe which has been shown in preliminary studies to be sensitive and specific for detection of prostate cancer. All lesions detected on PET/MRI will undergo biopsy under ultrasound using fused PET/MRI and ultrasound images for guidance, and compared to histopathology. The primary outcome measure in this study is the proportion of clinically significant prostate cancers that are detected with PET/MRI compared to MRI alone. Improved detection of clinically significant prostate cancer may enable a tailored, personalized therapeutic approach, decreasing morbidity and potentially improving overall patient outcome.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 1 May 2017
- Start date
- 8 Jun 2017
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Prostate cancer
- NCT number
- NCT03149861
What you commit to
- Study type: Interventional
- Participants enrolled: 56
- From 8 Jun 2017 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prostate biopsy \<8 weeks prior to planned PET-MR.
Other
- Patients will be ineligible to participate in this study if they meet any of the following criteria:
- Contraindication for MR as per current institutional guidelines.
- Contraindication for Gadolinium injection as per current institutional guidelines.
- Inability to lie supine for at least 60 minutes.
Who the study is looking for
- Patients accrued will fit any of the following criteria:
- Clinical suspicion of PCa with negative TRUS-guided biopsy or clinically discordant low-risk PCa (suspicion of more extensive/aggressive disease).
- Potential candidates for FT (as per institutional guidelines).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.