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

NCT03149861 | Completed

• 1 other identifier: CAPCR ID:17-5295
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasm, Prostate

Outcome Measures

Primary Outcomes (1)

• Rate of clinically significant prostate cancer (csPCa) detected in the study population by 18F-DCFPyL-PET/mpMR as compared to mpMR alone

  We will compare rates of csPCa detection in 18F-DCFPyL-PET, mpMR and fused 18F-DCFPyL-PET/mpMR, with histopathology obtained at targeted fused US-PET/MR biopsy as the standard of reference

  Through study completion, up to 2 years

Secondary Outcomes (2)

• Change in eligibility for focal therapy according to each modality

  Through study completion, up to 2 years

• Correlation of tumor grade to PSMA expression on PET (SUV).

  Through study completion, up to 2 years

Study Arms (2)

No focal biopsy needed

EXPERIMENTAL

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)

Procedure: Systemic TRUS guided biopsy

Focal biopsy

EXPERIMENTAL

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

Procedure: PET/MR-ultrasound guided Fusion biopsy

Interventions

PET/MR-ultrasound guided Fusion biopsy PROCEDURE

All focal lesion with PI-RADS \>=3 on MR or with DCFPyL uptake on PET will undergo a focal fusion biopsy

Focal biopsy

Systemic TRUS guided biopsy PROCEDURE

Transrectal ultrasound guided systemic prostate biopsy

No focal biopsy needed

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Prostate biopsy \<8 weeks prior to planned PET-MR.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (3)

• Mirshahvalad 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 DERIVED

• Basso 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 DERIVED

• Metser 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 11, 2017
• Study Start: June 8, 2017
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)