64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA) (COBRA)

64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 1/2 Study of Participants With Biochemical Recurrence of Prostate Cancer

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-bisPSMA and determine the ability of 64Cu-SAR-bisPSMA Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with biochemical recurrence of prostate cancer following definitive therapy.

Study Overview

• Status: Completed
• Conditions: Biochemical Recurrence of Malignant Neoplasm of Prostate
• Intervention / Treatment: Drug: 64Cu-SAR-bisPSMA

Detailed Description

Participants with biochemical evidence of recurrence of PC were evaluated with 64CU-SAR-bisPSMA PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later, eg. Histopathology/biopsy, conventional imaging, PSA reduction post focal salvage therapy or radiotherapy with no concomitant androgen deprivation therapy. Three independent central readers blinded to the participant number, the time of the PET/CT scan and the results of the conventional methodologies assessed the 64Cu-SAR-bisPSMA PET/CT. Three separate independent readers assessed the results of the conventional methodologies.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Tower Urology
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • GU Research Network
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • New Mexico Cancer Center
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • San Antonio, Texas, United States, 78258
      • Urology San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Life expectancy ≥ 12 weeks as determined by the Investigator.
4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.

5. Suspected recurrence of prostate cancer (PC) based on rising Prostate-specific antigen (PSA) after definitive therapy on the basis of:

   1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per American Urological Association recommendation) or
   2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per American Society for Therapeutic Radiology and Oncology-Phoenix consensus definition).
6. Negative or equivocal findings for PC on conventional imaging performed as part of standard of care workup within 60 days prior to Day 0.
7. The Eastern Cooperative Oncology performance status 0-2.
8. Adequate recovery from acute toxic effects of any prior therapy.
9. Estimated Glomerular Filtration Rate of 30 mL/min or higher.
10. Adequate liver function.
11. For participants who have partners of childbearing potential: Partner and/or participant must use a method of birth control with adequate barrier protection.

Exclusion Criteria:

1. Participants who received other investigational agents within 28 days prior to Day 0.
2. Participants administered any high energy (>300 kiloelectronvolts (keV)) gamma-emitting radioisotope within 5 physical half-lives prior to Day 0.
3. Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy (e.g. androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist) for PC.
4. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
5. 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 64Cu-SAR-bisPSMA; Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-bisPSMA.	Drug: 64Cu-SAR-bisPSMA; 64Cu-SAR-bisPSMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Incidence and severity of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events. Adverse Events were assessed by CTCAE version 5.0	up to 7 days post injection
Participant-level Correct Detection Rate (CDR)- Day 0	The percentage of TP participants on the Day 0 scan out of all participants with a Day 0 scan.	Day 0 (1- 4 hours) post injection
Participant-level CDR- Day 1	The percentage of TP participants on the Day 1 scan out of all participants with a Day 1 scan.	Day 1 (24+/-6 Hours) post injection
Region-level Positive Predictive Value (PPV)- Day 0	The percentage of TP regions on the Day 0 scan out of all positive regions on the Day 0 scan.	Day 0 (1- 4 hours)
Region-level PPV- Day 1	The percentage of TP regions on the Day 1 scan out of all positive regions on the Day 1 scan.	Day 1 (24 +/- 6 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biodistribution of 64Cu-SAR-bisPSMA- SUVmean	The mean Standardized Uptake Value (SUVmean) in lesions, visceral soft tissue and bone.	Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injection
Biodistribution of 64Cu-SAR-bisPSMA- SUVmax	SUVmax in lesions, visceral soft tissue and bone	Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Biodistribution of 64Cu-SAR-bisPSMA- SUVr	Lesion to Background ratio. SUVmax of the lesion divided by the SUVmean of gluteus background	Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level PPV	Percentage of TP participants on the Day 0 or Day 1 scan out of all participants with a positive Day 0 or Day 1 scan.	Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level Detection Rate (DR)	Percentage of participants with a positive Day 0 or Day 1 scan out of all participants with a Day 0 or Day 1 scan.	Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Participant-level False Positive Rate (FPR)	Percentage of false positive (FP) participants on the Day 0 or Day 1 scan out of all participants with a positive Day 0 or Day 1 scan.	Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Region-level FPR	Percentage of FP regions on the Day 0 or Day 1 scan out of all positive regions on the Day 0 or Day 1 scan.	Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
Participant-level Discrepant PET Negativity Rate	Percentage of participants with contradicting Day 0 and Day 1 results for whom the Reference Standard was positive.	Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
Participant-level True Negative Rate (TNR)	Percentage of TN participants on the Day 0 or Day 1 scan out of all participants with a negative Day 0 or Day 1 scan.	Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
Region-level TNR	Percentage of TN regions on the Day 0 or Day 1 scan out of all negative regions on the Day 0 or Day 1 scan.	Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)

Collaborators and Investigators

• Sponsor: Clarity Pharmaceuticals Ltd
• Investigators: Study Director: Othon Gervasio, Clarity Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Neoplasms; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: CLP06

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