F18 DCFPyL PET/CT in Imaging Participants With Recurrent... | NCT03501940

Studies
F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer

NCT03501940

Sponsor

Andrei Iagaru

Status

No longer available

Last Update Posted

Jan 21, 2022Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Prostate Adenocarcinoma
PSA Level Greater Than 0.2
PSA Level Greater Than or Equal to Two
PSA Progression
Recurrent Prostate Carcinoma

Interventions

Computed Tomography
Fluorine F 18 DCFPyL
Laboratory Biomarker Analysis
Positron Emission Tomography

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

ID	Type	Description	Link
NCI-2018-00479	Registry Identifier	CTRP (Clinical Trial Reporting Program)
PROS0083	Other Identifier	OnCore

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 10, 2018

First Submission Date that Met QC Criteria

Apr 17, 2018

First Posted Date

Apr 18, 2018Actual

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

Jan 6, 2022

Last Update Posted Date

Jan 21, 2022Actual

Description Module

Brief Summary

This study provides fluorine F 18 DCFPyL positron emission tomography/computed tomography (PET/CT) to participants with prostate cancer that has come back. Diagnostic procedures, such as fluorine F 18 DCFPyL PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate fluorine F 18 DCFPyL (18F-DCFPyL) PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA).

OUTLINE:

Participants receive fluorine F 18 DCFPyL intravenously (IV). After 60-120 minutes, participants undergo whole body PET/CT. Immediately after the first scan, participants may undergo a second PET/CT without receiving fluorine F 18 DCFPyL.

After completion of study, participants are followed up at 24-72 hours.

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Intermediate-type Population

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Other Names
Computed Tomography	Procedure	Undergo 18F-DCFPyL PET/CT	CAT CAT Scan Computerized Axial Tomography computerized tomography CT CT SCAN tomography
Fluorine F 18 DCFPyL	Radiation	Given IV	18F-DCFPyL
Laboratory Biomarker Analysis	Other	Correlative studies
Positron Emission Tomography	Procedure	Undergo 18F-DCFPyL PET/CT	Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy proven prostate adenocarcinoma
Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
- Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
  - PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy
  - Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
- Post-radiation therapy - American Society for Radiation Oncology (ASTRO) - Phoenix consensus definition
  - A rise of PSA measurement of 2 or more ng/mL over the nadir
Able to provide written consent
Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group [ECOG] / World Health Organization [WHO] equivalent)

Exclusion Criteria:

Unable to provide informed consent
Inability to lie still for the entire imaging time
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

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

Name	Affiliation	Role
Andrei Iagaru	Stanford Cancer Institute Palo Alto	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Cancer Institute Palo Alto		Palo Alto	California	94304	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33674398	Derived	Baratto L, Song H, Duan H, Hatami N, Bagshaw HP, Buyyounouski M, Hancock S, Shah S, Srinivas S, Swift P, Moradi F, Davidzon G, Iagaru A. PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2021 Nov;62(11):1545-1549. doi: 10.2967/jnumed.120.259630. Epub 2021 Mar 5.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
C572626	2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid
D009682	Magnetic Resonance Spectroscopy

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques