Clinical trial NCT06056830: Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Prostatic Neoplasms
Lead sponsor: Clarity Pharmaceuticals Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 383
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.


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.

Primary outcomes:
measure: Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Safety and tolerability of 64Cu-SAR-bisPSMA
timeFrame: Up to 16 weeks
measure: Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers
timeFrame: Up to 16 weeks
measure: PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs
timeFrame: Up to 16 weeks
measure: Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer
timeFrame: Up to 16 weeks
measure: Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic- Phoenix
state: Arizona
city: Los Angeles
country: United States
facility: Greater Los Angeles VA Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic- Jacksonville
state: Florida
city: Glenview
country: United States
facility: NorthShore University Health System
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Grand Rapids
country: United States
facility: BAMF Health
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic- Rochester
state: Minnesota
city: Omaha
country: United States
facility: XCancer Omaha LLC
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Doctors Urology Faculty Practice
state: New York
city: Tulsa
country: United States
facility: Urologic Specialists
state: Oklahoma
city: Springfield
country: United States
facility: Oregon Urology
state: Oregon
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates of Nashville
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: The Urology Place
state: Texas
city: Murray
country: United States
facility: Intermountain Health
state: Utah
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Sydney
country: Australia
facility: St. Vincent's Sydney
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
Study officials:
affiliation: Clarity Pharmaceuticals
name: Clarity Pharmaceuticals
role: STUDY_DIRECTOR
References: