NCT03149861: PSMA-DOCS

Detection of Clinically Significant Prostate Cancer With 18F-DCFPyL PET/MR

Completed NA Last updated 25 June 2025

What this trial tests

NA trial testing PET/MR-ultrasound guided Fusion biopsy in Neoplasm, Prostate in 56 participants. Completed in 1 March 2025.

Timeline

8 June 2017

Primary endpoint
1 March 2025

1 March 2025

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	56
Start date	8 June 2017
Primary completion	1 March 2025
Estimated completion	1 March 2025
Sites	1 location across Canada

Drugs / interventions tested

• PET/MR-ultrasound guided Fusion biopsy
• Systemic TRUS guided biopsy

Conditions studied

• Neoplasm, Prostate — all drugs for Neoplasm, Prostate →

Sponsor

University Health Network, Toronto

Who can join

18 and older, male only, with Neoplasm, Prostate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Detection of clinically significant prostate cancer with ¹⁸F-DCFPyL PET/multiparametric MR.
   Metser U, Ortega C, Perlis N, Lechtman E, et al · · 2021 · cited 24× · PMID 33846845 · DOI 10.1007/s00259-021-05355-7
2. Focal ablation therapy presents promising results for selectively localized prostate cancer patients.
   Feng D, Li D, Xiao Y, Wu R, et al · · 2023 · cited 22× · PMID 37691892 · DOI 10.21147/j.issn.1000-9604.2023.04.08
3. Canadian Urological Association best practice report: Prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) and PET/magnetic resonance (MR) in prostate cancer.
   Shaygan B, Zukotynski K, Bénard F, Ménard C, et al · · 2021 · cited 18× · PMID 33661093 · DOI 10.5489/cuaj.7268
4. Impact of 18F-DCFPyL PET/MRI in Selecting Men With Low-/Intermediate-Risk Prostate Cancer for Focal Ablative Therapies.
   Basso Dias A, Ghai S, Ortega C, Mirshahvalad SA, et al · · 2023 · cited 5× · PMID 37682613 · DOI 10.1097/rlu.0000000000004819
5. [18F]F-DCFPyL PET/MRI radiomics for intraprostatic prostate cancer detection and metastases prediction using whole-gland segmentation.
   Mirshahvalad SA, Basso Dias A, Ortega C, Abreu Gomez JA, et al · · 2025 · cited 2× · PMID 39847533 · DOI 10.1093/bjr/tqaf014