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64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE) (SABRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05407311
Recruitment Status : Recruiting
First Posted : June 7, 2022
Last Update Posted : September 29, 2022
Sponsor:
Information provided by (Responsible Party):
Clarity Pharmaceuticals Ltd

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

Condition or disease Intervention/treatment Phase
Biochemical Recurrence of Malignant Neoplasm of Prostate Drug: 64Cu-SAR-BBN Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants With PSMA-negative Biochemical Recurrence of Prostate Cancer
Actual Study Start Date : September 19, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 64Cu-SAR-BBN
Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-BBN.
Drug: 64Cu-SAR-BBN
64Cu-SAR-BBN




Primary Outcome Measures :
  1. Incidence and severity of 64Cu-SAR-BBN Treatment-Emergent Adverse Events and Serious Adverse Events [Safety and Tolerability] [ Time Frame: 7 days ]
    Adverse Events will be as assessed by CTCAE version 5.0

  2. Participant-level correct detection rate [ Time Frame: 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 [ Time Frame: 24 hour ]
    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 [ Time Frame: 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 [ Time Frame: 24 hours ]
    Proportion of true positive regions on the Day 1 scan out of all positive regions on the Day 1 scan



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 (1) approved PSMA PET and (2) anatomical imaging (CT and/or magnetic resonance imaging) and (3) if available, any other conventional imaging performed as part of routine standard of care imaging 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-BBN 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05407311


Contacts
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Contact: Clarity Pharmaceuticals +61 (0) 292094037 clinicaltrials@claritypharmaceuticals.com

Locations
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United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Principal Investigator: Hong Song, MD         
United States, Maryland
Advanced Molecular Imaging and Therapy Not yet recruiting
Glen Burnie, Maryland, United States, 21061
Principal Investigator: Michael Morris, MD         
United States, Michigan
Bamf Health, Inc Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: Brandon Mancini, MD         
United States, Nebraska
GU Research Network Recruiting
Omaha, Nebraska, United States, 68130
Contact: Tony Romero    402-690-3716    tromero@gucancer.com   
Principal Investigator: Luke Nordquist, MD         
Sponsors and Collaborators
Clarity Pharmaceuticals Ltd
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Responsible Party: Clarity Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT05407311    
Other Study ID Numbers: CLB03
First Posted: June 7, 2022    Key Record Dates
Last Update Posted: September 29, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Disease Attributes
Pathologic Processes