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

• Sponsor: Luke Nordquist, MD (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05286840
• Collaborator: Clarity Pharmaceuticals (Other)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 18.1
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: 64Cu-SAR-bisPSMA	Phase 1/Phase 2

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: A prospective, non-randomized, single arm, single center, open-label study .A prospective, non-randomized, single arm, single center, open-label study .
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer: A Prospective, Non-randomized, Single Arm, Single Center, Open-label Phase 1/2 Study
• Anticipated Study Start Date: Mar 28, 2022
• Anticipated Primary Completion Date: Mar 28, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Outcome Measures

Primary Outcome Measures

1. To assess safety of 64Cu-SAR-bisPSMA (all patients). [From injection of 64Cu-SAR-bisPSMA to one week following.]

   To assess treatment emergent adverse events.

Secondary Outcome Measures

1. 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 status will be assessed before and after 64Cu-SAR-bisPSMA PET/CT Imaging.

2. 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]

   Disease staging will be assessed before and after 64Cu-SAR-bisPSMA PET/CT Imaging

3. Clinical Management plan before vs after 64Cu-SAR-bisPSMA PET/CT Imaging. [Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging]

   Clinical Management plan will be documented before and after 64Cu-SAR-bisPSMA PET/CT Imaging.

Other Outcome Measures

1. Disease detection ability of 64Cu-SAR-bisPSMA PET (all patients). [Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging]

   64Cu-SAR-bisPSMA PET/CT Imaging will be used to detect prostate cancer.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GU Research Network	Omaha	Nebraska	United States	68130

Sponsors and Collaborators

• Luke Nordquist, MD
• Clarity Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Luke Nordquist, MD, Sponsor/Principal Investigator, GU Research Network, LLC
• ClinicalTrials.gov Identifier: NCT05286840
• Other Study ID Numbers: GU22-002
• First Posted: Mar 18, 2022
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Mar 18, 2022