Clinical trial NCT06970847: 64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
Official title: 64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Prostate Cancer Patients With Detectable PSA Following Prostatectomy
Prostate Cancer Recurrent
Prostate Cancer Patients Who Have Brachytherapy Seed Implant
Prostate Cancer Patients Treated by Radiotherapy
Cryotherapy
Keywords: Prostate Cancer
Prostate
Biochemical Recurrence
Lead sponsor: Clarity Pharmaceuticals Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-14
Enrollment: 220
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 for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Life expectancy ≥ 6 months as determined by the Investigator.
4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy.
5. Participant potentially eligible for salvage therapy with curative intent.
6. PSA level after definitive therapy:

   1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or
   2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition).
7. Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible.
8. An Eastern Cooperative Oncology performance status of 0-2.

Exclusion Criteria:

1. Participants who received investigational agent within 5 biological half-lives prior to Day 1.
2. Participants administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
3. Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy).
4. Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC.
5. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
6. Any serious medical condition or extenuating circumstance (including receiving the investigational product or not capable of having a PET scan) which the investigator feels may interfere with the procedures or evaluations of the study.

Primary outcomes:
measure: Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
timeFrame: Up to 52 Weeks
Secondary outcomes:
measure: To investigate the safety and tolerability of 64-CuSAR-bisPSMA
timeFrame: Up to 52 Weeks
measure: To assess the participants-level PPV of 64Cu-SAR-bisPSMA PET/CT
timeFrame: Up to 52 Weeks
measure: To assess the participant-level DR of 64Cu-SAR-bisPSMA PET/CT
timeFrame: Up to 52 Weeks
measure: To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline
timeFrame: Up to 52 Weeks
measure: To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT
timeFrame: Up to 52 Weeks
measure: To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings
timeFrame: Up to 52 Weeks
measure: To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings
timeFrame: Up to 52 Weeks
measure: To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline
timeFrame: Up to 52 Weeks
measure: To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT
timeFrame: Up to 52 Weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: XCancer
state: Nebraska
Study officials:
References: