Prostate Cancer, Prostatic Neoplasms
Conditions
Brief summary
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Interventions
DRUG64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
Sponsors
Clarity Pharmaceuticals Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of 64Cu-SAR-bisPSMA | Up to 16 weeks | Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA |
| Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers | Up to 16 weeks | Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic |
| PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs | 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 |
| Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer | Up to 16 weeks | Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth |
| Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching | 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 |
Countries
Australia, Puerto Rico, United States
Contacts
CONTACTClarity Pharmaceuticals
STUDY_DIRECTORClarity Pharmaceuticals
Clarity Pharmaceuticals
Outcome results
None listed