Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Status
RECRUITING
Phase
PHASE3
Age
≥ 18 Years
Enrollments
383Conditions
Prostate Cancer, Prostatic NeoplasmsDrugs
64Cu-SAR-bisPSMASummary
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Locations
17 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Jack Andrews, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Gholam R. Berenji, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Hong Song, MD, PhD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Ephraim Parent, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Brian Helfand, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Clayton McNamara
- [email protected]
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Brian Lane, MD, PhD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Jeffrey Karnes, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Tony Romero
- 402-991-8468
- [email protected]
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Shaun GS Grewal, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Neal Shore, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- David Morris, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Alexander Parker, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Orhan Oz, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Naveen Kella, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Dustin L. Boothe, MD
Study Director
- Clarity Pharmaceuticals
Status
- RECRUITING
Contact Person
- Steve Y Cho, MD
Study Director
- Clarity Pharmaceuticals
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.
Study Plan
64Cu-SAR-bisPSMA
EXPERIMENTAL
200MBq 64Cu-SAR-bisPSMA.
DRUG:
64Cu-SAR-bisPSMADescription:
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
Outcome Measures
Primary Outcome Measures
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
Secondary Outcome Measures
Safety and tolerability of 64Cu-SAR-bisPSMA
Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers
PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs
Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching
Timeline
Last Updated
November 5, 2024Start Date
September 28, 2023Today
January 23, 2025Completion Date ( Estimated )
February 1, 2025
Sponsors of this trial
Lead Sponsor
Clarity Pharmaceuticals Ltd
RECRUITING 
21 - 64 Years