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

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.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

* Patients accrued will fit any of the following criteria:

  1. Clinical suspicion of PCa with negative TRUS-guided biopsy or clinically discordant low-risk PCa (suspicion of more extensive/aggressive disease).
  2. Potential candidates for FT (as per institutional guidelines).

Exclusion Criteria:

Patients will be ineligible to participate in this study if they meet any of the following criteria:

1. Contraindication for MR as per current institutional guidelines.
2. Contraindication for Gadolinium injection as per current institutional guidelines.
3. Inability to lie supine for at least 60 minutes.
4. Prostate biopsy \<8 weeks prior to planned PET-MR.

• DERIVEDMirshahvalad SA, Basso Dias A, Ortega C, Abreu Gomez JA, Krishna S, Perlis N, Berlin A, van der Kwast T, Jhaveri K, Ghai S, Metser U, Santiago AT, Veit-Haibach P. [18F]F-DCFPyL PET/MRI radiomics for intraprostatic prostate cancer detection and metastases prediction using whole-gland segmentation. Br J Radiol. 2025 Oct 1;98(1174):1606-1614. doi: 10.1093/bjr/tqaf014. PMID 39847533
• DERIVEDBasso Dias A, Ghai S, Ortega C, Mirshahvalad SA, Perlis N, Berlin A, Avery L, Veit-Haibach P, van der Kwast T, Metser U. Impact of 18F-DCFPyL PET/MRI in Selecting Men With Low-/Intermediate-Risk Prostate Cancer for Focal Ablative Therapies. Clin Nucl Med. 2023 Oct 1;48(10):e462-e467. doi: 10.1097/RLU.0000000000004819. PMID 37682613
• DERIVEDMetser U, Ortega C, Perlis N, Lechtman E, Berlin A, Anconina R, Eshet Y, Chan R, Veit-Haibach P, van der Kwast TH, Liu A, Ghai S. Detection of clinically significant prostate cancer with 18F-DCFPyL PET/multiparametric MR. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3702-3711. doi: 10.1007/s00259-021-05355-7. Epub 2021 Apr 12. PMID 33846845