Prostate Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

23

Study ID:

NCT02420977

Recruitment Status:

Recruiting

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There is 1 Location for this study

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The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21287, United States More Info
Phuoc Tran, M.D., Ph.D.
Contact
410-614-3880
[email protected]
Terrence Caldwell
Contact
(443) 287-1889
[email protected]
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.
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

23

Study ID:

NCT02420977

Recruitment Status:

Recruiting

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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