Study of 18F-DCFPyL PET/CT Imaging in Patients With Prost... | NCT03800784

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

NCT03800784

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

Withdrawn

Last Update Posted

Dec 15, 2021Actual

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

Prostate Cancer

Interventions

18F-DCFPyL Injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB00150136	Other Identifier	JHM IRB

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Oct 21, 2021Actual

Completion Date

Oct 21, 2021Actual

First Submitted Date

Jan 9, 2019

First Submission Date that Met QC Criteria

Jan 9, 2019

First Posted Date

Jan 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2021

Last Update Posted Date

Dec 15, 2021Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
18F-DCFPyL Injection	Experimental	A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL	Drug: 18F-DCFPyL Injection

Name	Type	Description	Arm Group Labels	Other Names
18F-DCFPyL Injection	Drug	A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL	18F-DCFPyL Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality	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)	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms