Ga-68-PSMA-11 in Men With Prostate Cancer | NCT05744115

Studies
Ga-68-PSMA-11 in Men With Prostate Cancer

NCT05744115

Sponsor

Timothy Hoffman

Status

Terminated

Last Update Posted

Feb 24, 2023Actual

Enrollment

38Actual

Phase

Phase 3

Conditions

Prostate Cancer
Prostate Adenocarcinoma

Interventions

Ga-68-PSMA-11

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

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The investigational product was approved by the FDA (12/20/2021) and is now commercially available

Expanded Access Info

Start Date

Jul 27, 2021Actual

Primary Completion Date

Apr 14, 2022Actual

Completion Date

Apr 14, 2022Actual

First Submitted Date

Feb 1, 2023

First Submission Date that Met QC Criteria

Feb 15, 2023

First Posted Date

Feb 24, 2023Actual

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

Feb 15, 2023

Last Update Posted Date

Feb 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Timothy Hoffman, Research Career Scientist, Harry S. Truman Memorial Veterans' HospitalSponsor-Investigator

Lead Sponsor

Timothy HoffmanFED

Collaborators

Name	Class
Harry S. Truman Memorial Veterans' Hospital	FED
University of Missouri-Columbia	OTHER
Telix Pharmaceuticals (Innovations) Pty Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to provide access to Ga-68-PSMA-11 PET for evaluation of male veterans with newly diagnosed or biochemically recurrent prostate cancer. All patients will receive conventional imaging (MRI, CT, and/or a molecular imaging bone scan) as well as Ga-68-PSMA-11 PET in order to evaluate the utility of diagnostic testing in patients with positive PSA status, a comparison of results from conventional imaging and PSMA PET imagining will be performed.

Detailed Description

Participants (male veterans) with initial diagnosis of prostate cancer or biochemically recurrent disease that consent to participate in the study will receive both conventional imaging (MRI, CT, and/or molecular imaging bone scan) as well as Ga-68-PSMA-11 PET/CT. Following baseline assessment (Visit #1), Ga-68-PSMA-11 (3-7 mCi) will be administered as a single intravenous administration with PET/CT performed approximately 60 minutes after injection (Visit #2A). At approximately 120 minutes after injection of Ga-68-PSMA-11, the final evaluation for safety and tolerability will occur (Visit #2B)

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ga-68-PSMA-11 PET/CT	Experimental	Administration of Ga-68-PSMA-11 and acquisition of PET/CT	Drug: Ga-68-PSMA-11

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ga-68-PSMA-11	Drug	Ga-68-PSMA-11 is produced via a lyophilized Sterile Cold kit. Ga-68 is eluted from a Ge-68/Ga-68 generator into a vial containing the premixed peptide and buffer. PSMA-11 radiolabeled with Ga-68 is administered to patients following verification of standard quality controls including activity measurement, pH, radiochemical purity, and visual inspection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concurrence with Conventional Imaging	Localized vs extra-pelvic recurrence will be determined for each patient based on Ga-68-PSMA-11 PET/CT and standard-of-care radiological imaging	Up to 28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to tolerate PET/CT imaging and one or more of the following:
Patients with newly diagnosed prostate cancer with primary staging classified at high/intermediate risk per NCCN guidelines OR
Biochemical Recurrence: Patients with rising PSA after definitive therapy with prostatectomy or radiation therapy or other local therapies

Exclusion Criteria:

Claustrophobia or any other condition that would preclude PET/CT imaging.
Any constellation of medical conditions that indicate expectancy of less than one year

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male Veterans over the age of 18 years with previously diagnosed prostate cancer

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy J Hoffman, PhD	Truman VA Hospital; Columbia, MO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Truman VA Hospital		Columbia	Missouri	65201	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

A de-identified, anonymized dataset will be prepared to share with other VA investigators upon request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000718244	gallium 68 PSMA-11

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

All eligible and consenting participants (male veterans) will receive a single administration of 3-7mCi Ga-68-PSMA-11 per enrollment in addition to conventional imaging (MRI, CT, and/or molecular imaging bone scan).