Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Clarity Pharmaceuticals Ltd
- Study ID
- NCT06056830
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 64Cu-SAR-bisPSMA — DRUGAll Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
Study Details
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Key Dates
- Start date
- Dec 21, 2023
- Status verified
- May 2026
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 383 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: 64Cu-SAR-bisPSMA200MBq 64Cu-SAR-bisPSMA.
Primary Outcome Measure
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases [ Time Frame: Up to 16 weeks ]
Central Contacts
- Clarity Pharmaceuticals+61 (0) 2 9209 4037
Locations (27)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama Birmingham Hospital | Birmingham | Alabama | 35249-6830 | Jonathan E McConathy, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic- Phoenix | Phoenix | Arizona | 85054 | Jack Andrews, MD |
| Arkansas Urology Research Center, LLC | Little Rock | Arkansas | 72211 | R. Jonathan Henderson, MD (PRINCIPAL_INVESTIGATOR) |
| Greater Los Angeles VA Medical Center | Los Angeles | California | 90073 | Gholam R. Berenji, MD |
| Urology Group of Southern California | Los Angeles | California | 90017 | Carlos Lopez Yvette Zuniga John Kowalczyk (PRINCIPAL_INVESTIGATOR) |
| UC Irvine Health | Orange | California | 92868 | 877-827-8839 Edward Uchio, MD, FACS, CPI (PRINCIPAL_INVESTIGATOR) |
| Stanford University Medical Center | Stanford | California | 94305-5105 | Hong Song, MD, PhD |
| Mayo Clinic- Jacksonville | Jacksonville | Florida | 32224 | Ephraim Parent, MD |
| Biogenix Molecular, LLC | Miami | Florida | 33165 | Serguei A Castaneda, MD (PRINCIPAL_INVESTIGATOR) |
| NorthShore University Health System, Glenbrook Hospital | Glenview | Illinois | 60026 | Brian Helfand, MD |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | Clint D Bahler, MD (PRINCIPAL_INVESTIGATOR) |
| Wichita Urology Group | Wichita | Kansas | 67226 | Timothy Richardson, MD (PRINCIPAL_INVESTIGATOR) |
| BAMF Health | Grand Rapids | Michigan | 49503 | Clayton McNamara Harshad Kulkarni, MD (PRINCIPAL_INVESTIGATOR) |
| Corewell Health | Grand Rapids | Michigan | 49503 | Conrad Tobert (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic- Rochester | Rochester | Minnesota | 55905 | Jeffrey Karnes, MD |
| XCancer Omaha LLC | Omaha | Nebraska | 68130 | Luke Nordquist, MD (PRINCIPAL_INVESTIGATOR) |
| Mount Sinai Doctors Urology Faculty Practice | New York | New York | 10029 | Ashutosh Tewari, MD (PRINCIPAL_INVESTIGATOR) |
| Duke University Medical Center | Durham | North Carolina | 27710 | Terence Z Wong, MD, PhD, FACR (PRINCIPAL_INVESTIGATOR) Judd W Moul, MD, FACS (PRINCIPAL_INVESTIGATOR) |
| Urologic Specialists | Tulsa | Oklahoma | 74146 | Shaun GS Grewal, MD |
| Oregon Urology | Springfield | Oregon | 97477 | Bryan Mehllhaff, MD |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | Neal Shore, MD (PRINCIPAL_INVESTIGATOR) |
| Urology Associates of Nashville | Nashville | Tennessee | 37209 | David Morris, MD |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8896 | Radiology Clinical Research Office |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | Alexander Parker, MD |
| The Urology Place | San Antonio | Texas | 78240 | Naveen Kella, MD |
| Intermountain Health | Murray | Utah | 84107 | Dustin L. Boothe, MD |
| University of Wisconsin | Madison | Wisconsin | 53705 | Nandakumar Menon, MD |
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