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

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ClinicalTrials.gov Identifier: NCT02420977
Recruitment Status : Not yet recruiting
First Posted : April 20, 2015
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Prostate Cancer Drug: Pelvic DCFPyL PET-MRI fusion or PET/MRI Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of PSMA-based PET as an Imaging Biomarker of Androgen Receptor Signaling in High-Risk Localized and Locally Advanced Prostate Cancer
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420977


Contacts
Contact: Phuoc Tran, M.D., Ph.D. (410) 614-3880 tranp@jhmi.edu

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Phuoc Tran, M.D., Ph.D.    410-614-3880    tranp@jhmi.edu   
Contact: Terrence Caldwell    (443) 287-1889    caldwte@jhmi.edu   
Sub-Investigator: Katarzyna Macura, M.D., Ph.D.         
Sub-Investigator: Ronnie Mease, Ph.D.         
Sub-Investigator: Georges Netto, M.D.         
Sub-Investigator: Zsolt Szabo, M.D., Ph.D.         
Sub-Investigator: Bruce Trock, Ph.D.         
Sub-Investigator: Phuoc Tran, M.D., Ph.D.         
Sub-Investigator: Martin Pomper, M.D., Ph.D.         
Sub-Investigator: Edward Schaeffer, M.D., Ph.D.         
Sub-Investigator: Danny Song, M.D.         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
Principal Investigator: Theodore DeWeese, M.D. The SKCCC at Johns Hopkins

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02420977     History of Changes
Other Study ID Numbers: J1560
IRB00065395 ( Other Identifier: JHMIRB )
1U01CA183031-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
radiotracer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases