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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: 64Cu-SAR-bisPSMA

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • GU Research Network
      • Contact: Tony Romero; Phone Number: 402-690-3716; Email: tromerojr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	Disease staging will be assessed before and 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.	Clinical Management plan will be documented before and after 64Cu-SAR-bisPSMA PET/CT Imaging.	Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Luke Nordquist, MD
• Collaborators: Clarity Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 28, 2022
• Primary Completion (ANTICIPATED): March 28, 2023
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (ACTUAL): March 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: GU22-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No