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

Clarity Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Biochemical Recurrence of Malignant Neoplasm of Prostate

Treatments: Drug: 64Cu-SAR-bisPSMA

Study type: Interventional

Funder types: Industry

Identifiers

NCT05249127

CLP06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

64Cu-SAR-bisPSMA

Experimental group

Description:

Patients will receive a single administration of 200 megabecquerels (MBq) of 64Cu-SAR-bisPSMA.

Treatment:

Drug: 64Cu-SAR-bisPSMA