NCT06907641

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

March 26, 2025

Last Update Submit

April 1, 2025

Conditions

Prostate Cancer (Post Prostatectomy)

Keywords

Prostate CancerSalvage RadiotherapyProstatectomyCo-PSMACLP11Prostate Cancer RecurrenceBiochemical FailureRadical ProstatectomyCopperPET scan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

    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

  • +1 more secondary outcomes

Study Arms (1)

64Cu-SAR-bisPSMA

EXPERIMENTAL

200MBq 64Cu-SAR-bisPSMA

Drug: 64Cu-SAR-bisPSMA

Interventions

64Cu-SAR-bisPSMADRUG

All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA

64Cu-SAR-bisPSMA

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Ga PSMA-11 PET/CT within the last 4 weeks for prostate cancer biochemical recurrence.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Vincent's Hospital, Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Sobia Khan, MBBS, FRACP

CONTACT

+61 0283821830svhs.nm@svha.org.au

Louise Emmett, MBChB, FRACP, MD, FAANMS

CONTACT

+61 0283821830louise.emmett@svha.org.au

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 2, 2025

Study Start

November 21, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations

AU(1)