Clinical trial NCT05249127: 64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)
Official title: 64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 1/2 Study of Participants With Biochemical Recurrence of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Biochemical Recurrence of Malignant Neoplasm of Prostate
Lead sponsor: Clarity Pharmaceuticals Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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 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.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: up to 7 days post injection
measure: Participant-level Correct Detection Rate (CDR)- Day 0
timeFrame: Day 0 (1- 4 hours) post injection
measure: Participant-level CDR- Day 1
timeFrame: Day 1 (24+/-6 Hours) post injection
measure: Region-level Positive Predictive Value (PPV)- Day 0
timeFrame: Day 0 (1- 4 hours)
measure: Region-level PPV- Day 1
timeFrame: Day 1 (24 +/- 6 hours)
Secondary outcomes:
measure: Biodistribution of 64Cu-SAR-bisPSMA- SUVmean
timeFrame: Day 0 (1 -4 hours) and Day 1 (24 +/- 6 hours) post injection
measure: Biodistribution of 64Cu-SAR-bisPSMA- SUVmax
timeFrame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
measure: Biodistribution of 64Cu-SAR-bisPSMA- SUVr
timeFrame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
measure: Participant-level PPV
timeFrame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
measure: Participant-level Detection Rate (DR)
timeFrame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
measure: Participant-level False Positive Rate (FPR)
timeFrame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
measure: Region-level FPR
timeFrame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
measure: Participant-level Discrepant PET Negativity Rate
timeFrame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
measure: Participant-level True Negative Rate (TNR)
timeFrame: Day 0 (1-4 hours) and Day 1 (24 +/-6 hours)
measure: Region-level TNR
timeFrame: Day 0 (1-4 hours) and Day 1 (24 +/- 6 hours)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Omaha
country: United States
facility: GU Research Network
state: Nebraska
city: Albuquerque
country: United States
facility: New Mexico Cancer Center
state: New Mexico
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
Study officials:
affiliation: Clarity Pharmaceuticals
name: Othon Gervasio
role: STUDY_DIRECTOR
References: