Clinical trial
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
Aliases
CLP04, NCT06056830
Name
CLP04
Description
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Trial arms
Trial start
2023-11-30
Estimated PCD
2025-02-01
Trial end
2025-02-01
Status
Recruiting
Phase
Early phase I
Treatment
64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
Arms:
64Cu-SAR-bisPSMA
Size
383
Primary endpoint
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
Up to 16 weeks
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 383, 'type': 'ESTIMATED'}}
Updated at
2024-07-31
1 organization
Organization
Clarity Pharmaceuticals