Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy (Co-PSMA)

The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are:

• Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans.
• What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator.
• Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).

Participants will:

• have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only
• have standard of care blood test either at Visit 1 or Visit 2

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer (Post Prostatectomy)
• Intervention / Treatment: Drug: 64Cu-SAR-bisPSMA

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sobia Khan, MBBS, FRACP; Phone Number: +61 0283821830; Email: svhs.nm@svha.org.au
• Study Contact Backup: Name: Louise Emmett, MBChB, FRACP, MD, FAANMS; Phone Number: +61 0283821830; Email: louise.emmett@svha.org.au

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • St Vincent's Hospital, Sydney
      • Contact: Director of Theranostics and Nuclear Medicine; Phone Number: +61 0283821830; Email: louise.emmett@svha.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male patients aged 18 or above
• Ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study.
• Prior radical prostatectomy for confirmed adenocarcinoma on histopathology.
• Rising PSA (0.20 - 0.75 ng/mL) following radical prostatectomy with no prior salvage radiotherapy.
• 68Ga PSMA-11 PET/CT within the last 4 weeks for prostate cancer biochemical recurrence.

Exclusion Criteria:

• Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.
• History of current active malignancy as per investigator discretion other than prostate cancer.
• Known or expected hypersensitivity to 64Cu-SAR-bisPSMA
• Systemic therapy for metastatic prostate cancer including androgen deprivation therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 64Cu-SAR-bisPSMA; 200MBq 64Cu-SAR-bisPSMA	Drug: 64Cu-SAR-bisPSMA; All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT	Compare the detection rate of sites of prostate cancer recurrence, as determined by number of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT in patients with biochemical recurrence following radical prostatectomy who are being considered for curative salvage radiotherapy.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the number of lesions outside of the prostatic fossa per patient between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT.		12 months
Compare the diagnostic accuracy of 64Cu-SAR-bisPSMA versus 68Ga PSMA-11 PET/CT in the detection of recurrent or metastatic prostate cancer using a composite standard of truth	Compare the diagnostic accuracy of 64Cu-SAR-bisPSMA versus 68Ga PSMA-11 PET/CT in the detection of recurrent or metastatic prostate cancer using a composite standard of truth (biopsy, concurrent imaging and response to targeted therapy).	12 months
Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).		12 months
Compare the total number of lesions between 1 to 4-hour, and 24-hour 64Cu-SAR-bisPSMA PET/CT imaging timepoints.		12 months
Evaluate the frequency of prostatic fossa recurrence on the 24-hour 64Cu-SAR-bisPSMA images compared to the 1 to 4-hour 64Cu-SAR-bisPSMA and 1-hour 68Ga PSMA-11 PET/CT images		12 months
Evaluate biochemical (PSA) response following salvage radiotherapy by 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT imaging parameters in the presence of normal testosterone levels.		12 months

Collaborators and Investigators

• Sponsor: St Vincent's Hospital, Sydney
• Collaborators: Clarity Pharmaceuticals Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: PET scan; Prostate Cancer; Prostatectomy; Radical Prostatectomy; Copper; Salvage Radiotherapy; Biochemical Failure; Prostate Cancer Recurrence; Co-PSMA; CLP11
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: CLP11 (Co-PSMA); CT-2024-CTN-06035-1 (Other Identifier: Therapeutic Goods Administration)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No