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

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

Condition: Advanced Prostate Cancer

Intervention:

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

Purpose: 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 Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02420977

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Primary Outcome Measures:

  • Measure: Response rate differences
  • Time Frame: baseline and after 2-3 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Biomarker changes
  • Time Frame: Baseline and at 2=3 months
  • Safety Issue:
  • Measure: Metabolic tumor uptake changes
  • Time Frame: baseline and then at 2-3 months
  • Safety Issue:
  • Measure: Gene expression changes
  • Time Frame: Baseline and then at 2-3 months
  • Safety Issue:
  • Measure: Nodal metastatic disease changes
  • Time Frame: Baseline and then at 2-3 months
  • Safety Issue:
  • Measure: All cause DCFPyL PET-MRI fusion or PET/MRI toxicity
  • Time Frame: Baseline and then at 2-3 months
  • Safety Issue:

Estimated Enrollment: 24

Study Start Date: December 6, 2018

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: Male

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:

  • 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

Contact:

  • Phuoc Tran, M.D., Ph.D.
  • (410) 614-3880

Location:

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Baltimore Maryland 21287 United States

View trial on ClinicalTrials.gov

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