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

NCT ID: NCT05286840

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2023-09-30

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

64Cu-SAR-bisPSMA

Diagnostic PET/CT imaging agent targeted for Prostate Specific Membrane Antigen (PSMA)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Signed an informed consent.

2. >18 years of age.

3. 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.

4. The Eastern Cooperative Oncology (ECOG) performance status 0-2.

5. Adequate recovery from acute toxic effects of any prior therapy.

6. Adequate renal function (eGFR of 30 ml/min/1.73m2 or higher)

Exclusion Criteria

1. Participants must not receive other investigational agents within 28 days prior to 64Cu-SAR-bisPSMA administration.

2. Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to 64Cu-SAR-bisPSMA administration.

3. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.

4. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Clarity Pharmaceuticals

UNKNOWN

Sponsor Role: collaborator

Luke Nordquist, MD

OTHER

Sponsor Role: lead

Responsible Party

Luke Nordquist, MD

Sponsor/Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

GU Research Network

Omaha, Nebraska, United States

Countries

United States

Central Contacts

Tony Romero

Role: CONTACT

tromero@gucancer.com

402-697-2229

Facility Contacts

Tony Romero

Role: primary

tromerojr@gmail.com

402-690-3716

Other Identifiers

GU22-002

Identifier Type: -

Identifier Source: org_study_id