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

NCT05286840 | Unknown Phase 1 FDA Drug

• 1 other identifier: GU22-002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Disease status adjustment (patients with suspected disease at entry) before vs 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.

  Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging

• Clinical Management plan before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.

  Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging

Other Outcomes (1)

• Disease detection ability of 64Cu-SAR-bisPSMA PET (all patients).

  Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging

Interventions

64Cu-SAR-bisPSMA DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luke Nordquist, MD: lead
• Clarity Pharmaceuticals: collaborator

Study Sites (1)

GU Research Network

Omaha, Nebraska, 68130, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Tony Romero

CONTACT

402-697-2229; tromero@gucancer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/Principal Investigator

Model Details: A prospective, non-randomized, single arm, single center, open-label study .

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 18, 2022
• Study Start: March 28, 2022
• Primary Completion: March 28, 2023
• Study Completion: September 30, 2023
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)