PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer

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PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer

Condition: Prostate Cancer, Prostate Neoplasm

Intervention:

  • Drug: 18F-DCFPyL PET

Purpose: The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing for selection of an appropriate risk adaptive therapy.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03232164

Sponsor: University of Wisconsin, Madison

Primary Outcome Measures:

  • Measure: 18F-DCFPyL PSMA-based PET and multi-parametric MRI with DWI for sub-study #1: Primary Prostate Cancer
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Evaluate 18F-DCFPyL PSMA-based PET for localization for sub-study #2: Biochemical Recurrence
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Compare detectability of 18F-DCFPyL for sub-study #3: Metastatic Androgen-Resistant Prostate Cancer
  • Time Frame: Up to 12 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Sub-study #1: Detection of local-nodal and distant metastatic disease (PET
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Sub-study #1: Correlation of 18F-DCFPyL PET and MRI
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Sub-study #1: Specificity of 18F-DCFPyL
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Sub-study #1: Low-dose CT versus MRI derived PET SUV
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Sub-study #2: Detection of local-nodal and distant metastatic disease (pelvic)
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Sub-study #2: Dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Sub-study #3: Contribution of whole body MRI DWI
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Sub-study #3: Quantitative accuracy
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Sub-study #3: Quantitative reproducibility
  • Time Frame: Up to 12 months
  • Safety Issue:

Estimated Enrollment: 36

Study Start Date: February 2, 2017

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for sub-study #1)
  • Prostate biopsy histology grade ≥ Gleason 6, positive biopsy >2 cores.
  • PSA > 0.2 ng/mL for Sub-study #2 or >1.0 ng/mL for Sub-study #3
  • Patients considered as candidates for and medically fit to undergo prostatectomy
  • At least 7 days after most recent prostate biopsy
  • Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities (Sub-study #3 only)

Exclusion Criteria:

  • Prior pelvic external beam radiation therapy or brachytherapy
  • Chemotherapy for prostate cancer
  • Hormone deprivation therapy
  • Investigational therapy for prostate cancer
  • Unable to lie flat during or tolerate PET/CT
  • Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
  • No prostatectomy scheduled more than 12 hours post imaging
  • Serum creatinine > 2 time the upper limit of normal
  • Total bilirubin > 3 times the upper limit of normal
  • Liver Transaminases > 5 times the upper limit of normal

Contact:

  • Gemma Gliori
  • (608) 262-7269

Location:

  • University of Wisconsin Carbone Cancer Center
  • Madison Wisconsin 53792 United States

View trial on ClinicalTrials.gov

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