68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recur... | NCT04216134

Studies
68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer

NCT04216134

Sponsor

City of Hope Medical Center

Status

Completed

Last Update Posted

Jun 15, 2023Actual

Enrollment

19Actual

Phase

Phase 1

Conditions

Biochemically Recurrent Prostate Carcinoma

Interventions

Gallium Ga 68-labeled PSMA-11
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

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
NCI-2019-08625	Registry Identifier	CTRP (Clinical Trial Reporting Program)
19517	Other Identifier	City of Hope Comprehensive Cancer Center
P30CA033572	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Dec 12, 2019Actual

Primary Completion Date

Dec 9, 2022Actual

Completion Date

Dec 9, 2022Actual

First Submitted Date

Dec 30, 2019

First Submission Date that Met QC Criteria

Dec 30, 2019

First Posted Date

Jan 2, 2020Actual

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

Jun 14, 2023

Last Update Posted Date

Jun 15, 2023Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This phase I trial studies the side effects of 68GA-PSMA-11 PET imaging in patients with prostate cancer that has come back (recurrent). Gallium (68Ga) is a radiotracer that binds to a molecule, PSMA, that is found in abundance on most prostate cancer cells. PSMA is short for 'prostate specific membrane antigen'. Diagnostic procedures, such as 68GA-PSMA-11 PET imaging, may help measure a patient's response to earlier treatment, and may help plan the best treatment for prostate cancer.

Detailed Description

PRIMARY OBJECTIVE:

I. To provide clinical access to and assess the safety of the investigational agent Gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA-11) positron emission tomography (PET) at City of Hope National Medical Center for patients co-enrolled on Institutional Review Board (IRB) 18517 treatment trial.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over less than 1 minute, and then undergo PET over 60 minutes.

After completion of study, patients are followed up at 1-3 days, and then at 3 weeks.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic (68GA-PSMA-11 PET)	Experimental	Patients receive gallium Ga 68-labeled PSMA-11 IV over less than 1 minute, and then undergo PET over 60 minutes.	Drug: Gallium Ga 68-labeled PSMA-11 Procedure: Positron Emission Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gallium Ga 68-labeled PSMA-11	Drug	Given IV	Diagnostic (68GA-PSMA-11 PET)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events	Will be assessed by Common Terminology Criteria for Adverse Events version 5.0.	Up to 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biochemical recurrent prostate cancer
Karnofsky performance status of >= 50
The effects of 68Ga-PSMA-11 on the developing fetus are unknown. For this reason, subjects must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation when having sex with a pregnant female or with a female partner of childbearing potential
Co-enrollment on IRB 18517
Documented informed consent of the patient. All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

Patients should not have any uncontrolled illness including ongoing or active infection
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA-11
Use of another concomitant investigational therapy (with the exception of the investigational treatment given in IRB 18517) for prostate cancer within 7 days of scheduled 68Ga-PSMA-11 PET scan
Unable to tolerate PET scan (i.e. if the patient is claustrophobic or unable to lie still for 30-60 minutes)
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Accepts Healthy Volunteers

Sex

Male

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
Maria Parayno	City of Hope Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope Medical Center		Duarte	California	91010	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000718244	gallium 68 PSMA-11
C000622699	68Ga-DKFZ-PSMA-11
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

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