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Using 64Cu-SAR-bisPSMA PET to detect prostate cancer spread before surgery

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

Phase 3 Interventional Clarity Pharmaceuticals Ltd · NCT06056830

This study is testing a new imaging method to see if it can help find prostate cancer spread in high-risk patients before they have surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment383 (estimated)
Ages18 Years and up
SexMale
SponsorClarity Pharmaceuticals Ltd Industry-sponsored
Locations28 sites (Birmingham, Alabama and 27 other locations)
Trial IDNCT06056830 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of 64Cu-SAR-bisPSMA positron emission tomography (PET) in identifying regional nodal metastases in patients with high-risk prostate cancer. Participants will undergo this imaging technique prior to radical prostatectomy to determine its diagnostic performance. The study focuses on patients who have untreated, histologically confirmed adenocarcinoma of the prostate and meet specific high-risk criteria. The results could provide valuable insights into the staging of prostate cancer and guide treatment decisions.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 18 and older with untreated, high-risk prostate cancer who are planning to undergo radical prostatectomy.

Not a fit: Patients with predominant small cell or neuroendocrine prostate cancer or those who have received certain prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of prostate cancer staging and enhance treatment planning for patients.

How similar studies have performed: Other studies have shown promise in using PET imaging for cancer detection, but the specific use of 64Cu-SAR-bisPSMA is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate CancerProstatic Neoplasms
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.