PET Scan Test for Spread of High-risk Prostate Cancer to Lymph Nodes
Tests a PET scan tracer to detect prostate cancer spread to lymph nodes in adults.
Plain-language title generated from the registry record
Registry title: Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Key facts
- Where
- San Juan, Puerto RicoSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with untreated, high-risk prostate cancer who have chosen to have prostate removal surgery with lymph node removal. A PET scan with 64Cu-SAR-bisPSMA is tested.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Untreated, confirmed adenocarcinoma of the prostate that is high-risk or greater (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).
- Earlier treatment
- The prostate cancer must be untreated. People must have chosen to have radical prostatectomy (RP) with pelvic lymph node dissection (PLND).
Main reasons for not taking part
- Had a high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives before Day 1
- Known or expected allergy to 64Cu-SAR-bisPSMA or any of its components
- Known mainly small cell or neuroendocrine prostate cancer
Read by machine on 9 November 2026.
Where in Puerto Rico
- Pan American Center for Oncology Trials LLC - CiudadelaSan Juan, Puerto RicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Clarity Pharmaceuticals Ltd
- Trial code
- NCT06056830
- Record updated
- 11 September 2026
- Original description
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.Read full original descriptionShow less
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
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Inclusion: 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: 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.