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

NCT ID: NCT03800784

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-10-21

Brief Summary

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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

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Conditions

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Prostate Cancer

Keywords

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18F-DCFPyL PET/CT PyL PSMA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-DCFPyL Injection

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

Group Type EXPERIMENTAL

18F-DCFPyL Injection

Intervention Type DRUG

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

Interventions

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18F-DCFPyL Injection

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

Intervention Type DRUG

Other Intervention Names

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PyL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Markowski

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00150136

Identifier Type: OTHER

Identifier Source: secondary_id

J1863

Identifier Type: -

Identifier Source: org_study_id