Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer

March 18, 2025 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Evaluation of PSMA-based PET as an Imaging Biomarker of Androgen Receptor Signaling in High-Risk Localized and Locally Advanced Prostate Cancer

This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators propose to evaluate the feasibility of using a novel small molecule PET radiotracer, DCFPyL to target prostate cancer prostate-specific membrane antigen (PSMA). PSMA is a well studied cell surface marker of prostate cancer with increased expression associated with higher tumor grade and advanced metastatic tumors. More specifically it is associated with a higher Gleason score and there is evidence it can serve as a potential marker for prostate tumor carcinogenesis, progression and as a AR signaling surrogate marker of ADT response. This small molecule PET radiotracer specifically targeting an important prostate specific marker of AR signaling dynamics following ADT, tumor progression and metastatic potential warrants validation as an in-vivo non-invasive imaging biomarker for PSMA expression and prostate cancer detection.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Curtiland Deville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT.

  • Key inclusion criteria (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)

    • Newly diagnosed prostate cancer pathologically proven by prostate biopsy
    • Prostate biopsy histology grade ≥ Gleason 8-10
    • Patients considered as candidates for and medically fit to undergo radiation and ADT
    • At least 10 days after most recent prostate biopsy

Exclusion Criteria:

  • Prior pelvic external beam radiation therapy or brachytherapy
  • Chemotherapy for prostate cancer
  • Hormone deprivation therapy
  • Investigational therapy for prostate cancer
  • Hemorrhagic cystitis or active prostatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCFPyL PET-MRI fusion or PET/MRI
  • Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months of ADT
  • Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months
Drug: Pelvic DCFPyL PET-MRI fusion or PET/MRI
  • Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months of ADT
  • Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate differences
Time Frame: baseline and after 2-3 months
To compare the detection , sextant localization and response of DCFPyL PET-MRI fusion or PET/MRI before and after 2-3 months of ADT in men with biopsy-positive high-risk localized or locally advanced prostate cancer.
baseline and after 2-3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker changes
Time Frame: Baseline and at 2=3 months
To compare DCFPyL PET-MRI fusion or PET/MRI uptake in prostate cancer (quantified as per sextant SUVmax, SUVavg, metabolic tumor volume, total lesion DCFPyL uptake, DCFPyL uptake rate) as a reliable non-invasive imaging biomarker of PSMA expression following ADT as determined by qualitative and quantitative MRI-guided prostate biopsy core tissue immunohistochemical analysis. DCFPyL uptake will also be compared to other prostate cancer relevant marker expression levels (PSA, Ki-67, TMPRSS2-ERG) by immunohistochemical analysis.
Baseline and at 2=3 months
Metabolic tumor uptake changes
Time Frame: baseline and then at 2-3 months
To compare DCFPyL PET-MRI fusion or PET/MRI uptake in primary prostate cancer (quantified as per sextant SUVmax, SUVavg, metabolic tumor volume, total lesion DCFPyL uptake, DCFPyL uptake rate) following ADT with standard clinical prognostic markers (PSA, Gleason score, clinical stage) and with predictive model of pathologic stage.
baseline and then at 2-3 months
Gene expression changes
Time Frame: Baseline and then at 2-3 months
To validate DCFPyL PET-MRI fusion or PET/MRI uptake in prostate cancer (quantified as per sextant SUVmax, SUVavg, metabolic tumor volume, total lesion DCFPyL uptake, DCFPyL uptake rate) as a reliable non-invasive imaging biomarker of AR signaling following ADT as determined by AR gene set expression of biopsy core tissue specimens using qPCR.
Baseline and then at 2-3 months
Nodal metastatic disease changes
Time Frame: Baseline and then at 2-3 months
To compare the detection of nodal metastatic disease by DCFPyL PET-MRI fusion or PET/MRI at initial staging to detection by available conventional imaging modalities (bone scan, CT, MRI) and when available biopsy pathology.
Baseline and then at 2-3 months
All cause DCFPyL PET-MRI fusion or PET/MRI toxicity
Time Frame: Baseline and then at 2-3 months
To determine the safety of DCFPyL.
Baseline and then at 2-3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Curtiland Deville, M.D., The SKCCC at Johns Hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2018

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimated)

April 20, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1560
  • 1U01CA183031-01A1 (U.S. NIH Grant/Contract)
  • IRB00065395 (Other Identifier: JHM IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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