Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

Overview

This study evaluates the rate of radiological disease progression with the new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, in patients with metastatic castration (mCRPC) and non-metastatic (nmCRPC) castration resistant prostate cancer who have evidence of biochemical (PSA) disease progression without evidence of radiological disease progression on conventional standard radiologic testing (99mTc-methylene diphosphonate bone scan and CT).

Full Title of Study: “Study of 18F-DCFPyL PET/CT, for Detection of Radiological Progression in Patients With Metastatic (M+) and Non-metastatic (M0) Castration Resistant Prostate Cancer Receiving Standard Androgen Receptor Targeted Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 21, 2021

Interventions

  • Drug: 18F-DCFPyL Injection
    • A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Arms, Groups and Cohorts

  • Experimental: 18F-DCFPyL Injection
    • A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer
    • Time Frame: 3 years
    • Proportion of patients demonstrating disease progression by conventional criteria evaluated by CT scan and 99mTc-methylene diphosphonate bone scan and on 18F-DCFPyL PET/CT.

Secondary Measures

  • Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality
    • Time Frame: 3 years
    • Number of lesions detected on 18F-DCFPyL PET/CT in comparison to number of lesions detected on conventional imaging (99mTc-methylene diphosphonate bone scan and CT)

Participating in This Clinical Trial

Inclusion Criteria

  • Histological confirmation of prostate cancer – Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration. – Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both) – Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT – Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months. – Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart) – PSADT ≤ 9 months – Cohort B: mCRPC – Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted). – PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT – Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility. – No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced. – Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Exclusion Criteria:

  • Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark Markowski, Principal Investigator, Johns Hopkins University

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