Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06056830

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

St. Vincent's Sydney, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age.
  • Signed informed consent.
  • Untreated, histologically confirmed adenocarcinoma of the prostate.
  • High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).
  • Patients electing to undergo RP with PLND.

Exclusion criteria

  • Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
  • Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
  • Patients with known predominant small cell or neuroendocrine PC.

Treatment and study plan

64Cu-SAR-bisPSMA

Drug

All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.

Primary outcomes

  1. Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases

    Time frame: Up to 16 weeks

    Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.

Secondary outcomes

  1. Safety and tolerability of 64Cu-SAR-bisPSMA

    Time frame: Up to 16 weeks

    Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA

  2. Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers

    Time frame: Up to 16 weeks

    Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic

  3. PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs

    Time frame: Up to 16 weeks

    PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth

  4. Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer

    Time frame: Up to 16 weeks

    Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth

  5. Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching

    Time frame: Up to 16 weeks

    Sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth, without the requirement of subregion (Left or Right) matching between 64Cu-SAR-bisPSMA PET and Standard of Truth

Study contacts

Contact information is provided by the study sponsor or research team.

Clarity Pharmaceuticals

CONTACT

[email protected]

+61 (0) 2 9209 4037

Sponsors and collaborators

Lead sponsor

Clarity Pharmaceuticals Ltd

Industry

Registry information

Official study title

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

Acronym: CLARIFY

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.