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

Phase 2

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Drug: 18F-DCFPyL Injection

• Registration Number: NCT03800784
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-11
• Study Start: 2019-10-01
• Primary Completion: 2021-10-21
• Study Completion: 2021-10-21
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-DCFPyL Injection	18F-DCFPyL Injection	A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Primary Outcome Measures

Name	Time	Method
Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer	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 Outcome Measures

Name	Time	Method
Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality	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)

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States