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

Sponsor
Clarity Pharmaceuticals Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05249127
Collaborator
(none)
50
6
1
11.7
8.3
0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 1/2 Study of Participants With Biochemical Recurrence of Prostate Cancer
Actual Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of 64Cu-SAR-bisPSMA Treatment-Emergent Adverse Events and Serious Adverse Events [Safety and Tolerability] [7 days]

    Adverse Events will be as assessed by CTCAE version 5.0

  2. Participant-level correct detection rate [1- 4 hours]

    Proportion of true positive participants on the Day 0 scan out of all participants with a Day 0 scan.

  3. Participant-level correct detection rate [24 hours]

    Proportion of true positive participants on the Day 1 scan out of all participants with a Day 1 scan.

  4. Region-level positive predictive value [1- 4 hours]

    Proportion of true positive regions on the Day 0 scan out of all positive regions on the Day 0 scan

  5. Region-level positive predictive value [24 hours]

    Proportion of true positive regions on the Day 1 scan out of all positive regions on the Day 1 scan

Eligibility Criteria

Criteria

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

  6. 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

  7. 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).

  8. Negative or equivocal findings for PC on conventional imaging performed as part of standard of care workup within 60 days prior to Day 0.

  9. The Eastern Cooperative Oncology performance status 0-2.

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

  11. Estimated Glomerular Filtration Rate of 30 mL/min or higher.

  12. Adequate liver function.

  13. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tower Urology Los Angeles California United States 90048
2 Genesis Care Fort Myers Florida United States 33908
3 GU Research Network Omaha Nebraska United States 68130
4 New Mexico Cancer Center Albuquerque New Mexico United States 87109
5 Carolina Urologic Research Center Myrtle Beach South Carolina United States 29572
6 Urology San Antonio San Antonio Texas United States 78258

Sponsors and Collaborators

  • Clarity Pharmaceuticals Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clarity Pharmaceuticals Ltd
ClinicalTrials.gov Identifier:
NCT05249127
Other Study ID Numbers:
  • CLP06
First Posted:
Feb 21, 2022
Last Update Posted:
Jun 23, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2022