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NCT Number: NCT03471650

Study of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer

This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

SKCCC

Baltimore, Maryland, 21287, United States

About this study

This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population. 150 biopsy-naïve patients with an elevated PSA (2-10 ng/mL) will be enrolled in this study.

Within 28 days of informed consent, patients will undergo an 18F-DCFPyL PET/CT. All scans will be read by a single experienced radiologist who will identify regions of interest (ROI) with discrete radiotracer uptake. The maximum SUV value (SUVmax) of each ROI will be recorded. For patients without a detectable ROI, the mean SUV (SUVmean) of a 1-2 cm volume of the prostate will instead be recorded.

One to 28 days following PET/CT imaging, a systematic 12 to 14 core TRUS-guided prostate biopsy will be performed. Immediately following completion of systematic TRUS biopsies, fusion-targeted biopsies of all PET and/or MRI visible lesions will be performed, taking an additional 2 to 3 cores from each radiographic ROI. All biopsy cores will be assessed for Gleason score and percent cancer involvement.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age
  • PSA of 2-10 ng/mL
  • Clinical stage T1c-T2a on digital rectal exam
  • Elect to undergo TRUS-guided prostate biopsy as part of routine clinical care
  • Willingness to sign informed consent and comply with all protocol requirements

Exclusion criteria

  • History of prior prostate biopsy
  • Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT
  • Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT
  • Administered oral contrast medium ≤120 hours prior to the date of study PET/CT
  • Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives

Treatment and study plan

18F-DCFPyL Injection

Drug

A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.

Other names: PyL

Primary outcomes

  1. Sensitivity of 18F-DCFPyL PET/CT to detect clinically significant prostate cancer on prostate biopsy relative to serum prostate specific antigen (PSA)

    Time frame: 4 years

    Measure the diagnostic accuracy of 18F-DCFPyL PET/CT and compare it with serum PSA for detecting clinically significant prostate cancer on prostate biopsy

Secondary outcomes

  1. Sensitivity of 18F-DCFPyL PET/CT relative to PSA

    Time frame: 4 years

    Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to serum PSA for detecting clinically significant prostate cancer as defined by the following alternative definitions: Gleason score ≥4+3=7; Gleason score ≥3+4 or >50% involvement of ≥1 core with Gleason score ≥3+3=6 prostate cancer; Gleason score ≥3+4 or >70% involvement of ≥1 core with Gleason score ≥3+3=6 prostate cancer; Gleason score ≥3+4=7, or >2 cores with Gleason score ≥3+3=6, or >50% involvement of ≥1 core with Gleason score ≥3+3=6 prostate cancer.

  2. Sensitivity of 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer relative to mpMRI

    Time frame: 4 years

    Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to mpMRI for detecting clinically significant prostate cancer by the various tested definitions

  3. Sensitivity and diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions

    Time frame: 4 years

    Measure the diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Progenics Pharmaceuticals, Inc.

Registry information

Official study title

A Phase II Study to Evaluate the Performance of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate Cancer in Men With an Elevated PSA

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2018
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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