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

Johns Hopkins Medicine

Status and phase: Completed; Early Phase 1

Conditions: Advanced Prostate Cancer

Treatments: Drug: Pelvic DCFPyL PET-MRI fusion or PET/MRI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02420977

IRB00065395 (Other Identifier)

1U01CA183031-01A1 (U.S. NIH Grant/Contract)

J1560

Details and patient eligibility

About

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.

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.

Enrollment: 23 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

DCFPyL PET-MRI fusion or PET/MRI

Experimental group

Description:

* 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

Treatment:

Drug: Pelvic DCFPyL PET-MRI fusion or PET/MRI