64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer

Phase 3

Not yet recruiting

• 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
• Interventions: Drug: 64Cu-SAR-bisPSMA

• Registration Number: NCT06970847
• Lead Sponsor: Clarity Pharmaceuticals Ltd

Brief Summary

The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-29
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Study Start: 2025-05-31
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA.	64Cu-SAR-bisPSMA	-

Primary Outcome Measures

Name	Time	Method
Ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer	Up to 52 Weeks	Co-primary endpoints of participant-level CDR and region level PPV assessed independently for Day 1 and Day 2: * Participant-level CDR, defined as the proportion of TP participants scan out of all participants; * Region-level PPV, defined as the proportion of TP regions out of all positive regions.

Secondary Outcome Measures

Name	Time	Method
To investigate the safety and tolerability of 64-CuSAR-bisPSMA	Up to 52 Weeks	Incidence and severity of TEAEs and SAEs following the administration of 64CuSARbisPSMA
To assess the participants-level PPV of 64Cu-SAR-bisPSMA PET/CT	Up to 52 Weeks	Participant-level PPV, defined as the proportion of participants with a TP scan out of all participants with a true or false positive scan.
To assess the participant-level DR of 64Cu-SAR-bisPSMA PET/CT	Up to 52 Weeks	Participant-level DR, defined as the proportion of participants with a positive scan out of all participants.
To determine the efficacy of 64Cu-SAR-bisPSMA PET/CT in participants with negative or equivocal conventional imaging at baseline	Up to 52 Weeks	Positive Predictive Values (participant and region level) in participants with a negative or equivocal conventional imaging at baseline.
To determine the effect of the composition of Reference Standard on the performance of 64Cu-SAR-bisPSMA PET/CT	Up to 52 Weeks	Correct Detection Rate assessed in subgroups based on the type of evidence and with/without histopathology.
To evaluate the consistency among readers and the reproducibility of the 64Cu-SAR-bisPSMA PET/CT readings	Up to 52 Weeks	Intra-reader variability expressed with kappa statistics for the 64Cu-SAR-bisPSMA PET/CT interpretation by the three central readers.