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

NCT03800784 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: J1863IRB00150136
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

18F-DCFPyL PET/CT PyL; PSMA

Outcome Measures

Primary Outcomes (1)

• Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer

  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.

  3 years

Secondary Outcomes (1)

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

  3 years

Study Arms (1)

18F-DCFPyL Injection

EXPERIMENTAL

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

Drug: 18F-DCFPyL Injection

Interventions

18F-DCFPyL Injection DRUG

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

Also known as: PyL

18F-DCFPyL Injection

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mark Markowski

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: October 1, 2019
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)