64Cu-SAR-bisPSMA Positron Emission Tomography of Patients... | NCT05286840

Studies
64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer

NCT05286840

Sponsor

Luke Nordquist, MD

Status

Unknown status

Last Update Posted

Mar 18, 2022Actual

Enrollment

150Estimated

Phase

Phase 1Phase 2

Conditions

Prostate Cancer

Interventions

64Cu-SAR-bisPSMA

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 28, 2022Estimated

Primary Completion Date

Mar 28, 2023Estimated

Completion Date

Sep 30, 2023Estimated

First Submitted Date

Feb 28, 2022

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 18, 2022Actual

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

Mar 9, 2022

Last Update Posted Date

Mar 18, 2022Actual

Name	Class
Clarity Pharmaceuticals	UNKNOWN

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.

Detailed Description

This is a prospective, non-randomized, single arm, single center, open-label study of 64Cu-SAR-bisPSMA PET in patients with known or suspected prostate cancer (PC).

Patients will be screened during a 28-day period and assessed against the inclusion and exclusion criteria. During screening the investigator will determine the patient's disease status (for patients with suspected prostate cancer) or stage of disease (for patients with known prostate cancer) and management plan based on the available standard of care test results (including available imaging, histopathology, biochemical markers, clinical and symptoms history, etc.). Eligible patients will receive a single administration of 64Cu-SAR-bisPSMA and complete a PET scan at an early time (1-4 hours) and a late time (24-72 hours).

The patient's status will only be assessed in patients with suspected disease at study entry and will be characterized as suspected or known prostate cancer during the follow up.

Staging will only be assessed in patients with known prostate cancer at study entry and will be characterized according to the TNM system and as Localized, Regional or Distant (nodes/visceral/bone).

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
64Cu-SAR-bisPSMA	Diagnostic Test	Diagnostic PET/CT imaging agent targeted for Prostate Specific Membrane Antigen (PSMA)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess safety of 64Cu-SAR-bisPSMA (all patients).	To assess treatment emergent adverse events.	From injection of 64Cu-SAR-bisPSMA to one week following.

Secondary Outcomes

Measure	Description	Time Frame
Disease status adjustment (patients with suspected disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.	Disease status will be assessed before and after 64Cu-SAR-bisPSMA PET/CT Imaging.	Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging
Disease Staging adjustment (for patients with known disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.

Other Outcomes

Measure	Description	Time Frame
Disease detection ability of 64Cu-SAR-bisPSMA PET (all patients).	64Cu-SAR-bisPSMA PET/CT Imaging will be used to detect prostate cancer.	Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed an informed consent.
>18 years of age.
Known diagnosis of prostate adenocarcinoma confirmed by histopathology OR patients with suspicion of prostate cancer based on elevated PSA but negative standard of care imaging and/or negative biopsy.
The Eastern Cooperative Oncology (ECOG) performance status 0-2.
Adequate recovery from acute toxic effects of any prior therapy.
Adequate renal function (eGFR of 30 ml/min/1.73m2 or higher)

Exclusion Criteria:

Participants must not receive other investigational agents within 28 days prior to 64Cu-SAR-bisPSMA administration.
Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to 64Cu-SAR-bisPSMA administration.
Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

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

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tony Romero	Contact	402-697-2229		tromero@gucancer.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GU Research Network		Omaha	Nebraska	68130	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

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

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Browse Branches

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