Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 64Cu-SAR-bisPSMA | Experimental | 200MBq 64Cu-SAR-bisPSMA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 64Cu-SAR-bisPSMA | Drug | All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases | 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. | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of 64Cu-SAR-bisPSMA | Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA | Up to 16 weeks |
| Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clarity Pharmaceuticals | Contact | +61 (0) 2 9209 4037 | clinicaltrials@claritypharmaceuticals.com |
| Name | Affiliation | Role |
|---|---|---|
| Clarity Pharmaceuticals | Clarity Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham Hospital | Recruiting | Birmingham | Alabama | 35249-6830 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic
| Up to 16 weeks |
| PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs | PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth | Up to 16 weeks |
| Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer | Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth | Up to 16 weeks |
| Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching | 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 | Up to 16 weeks |
| Mayo Clinic- Phoenix | Recruiting | Phoenix | Arizona | 85054 | United States |
|
| Arkansas Urology Research Center, LLC | Recruiting | Little Rock | Arkansas | 72211 | United States |
|
| Urology Group of Southern California | Recruiting | Los Angeles | California | 90017 | United States |
|
| Greater Los Angeles VA Medical Center | Recruiting | Los Angeles | California | 90073 | United States |
|
| UC Irvine Health | Recruiting | Orange | California | 92868 | United States |
|
| Stanford University Medical Center | Recruiting | Stanford | California | 94305-5105 | United States |
|
| Mayo Clinic- Jacksonville | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| Biogenix Molecular, LLC | Recruiting | Miami | Florida | 33165 | United States |
|
| NorthShore University Health System, Glenbrook Hospital | Recruiting | Glenview | Illinois | 60026 | United States |
|
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| Wichita Urology Group | Recruiting | Wichita | Kansas | 67226 | United States |
|
| BAMF Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
|
| Corewell Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
|
| Mayo Clinic- Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| XCancer Omaha LLC | Recruiting | Omaha | Nebraska | 68130 | United States |
|
| Mount Sinai Doctors Urology Faculty Practice | Recruiting | New York | New York | 10029 | United States |
|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
|
| Urologic Specialists | Recruiting | Tulsa | Oklahoma | 74146 | United States |
|
| Oregon Urology | Recruiting | Springfield | Oregon | 97477 | United States |
|
| Carolina Urologic Research Center | Recruiting | Myrtle Beach | South Carolina | 29572 | United States |
|
| Urology Associates of Nashville | Recruiting | Nashville | Tennessee | 37209 | United States |
|
| Urology Clinics of North Texas | Recruiting | Dallas | Texas | 75231 | United States |
|
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390-8896 | United States |
|
| The Urology Place | Recruiting | San Antonio | Texas | 78240 | United States |
|
| Intermountain Health | Recruiting | Murray | Utah | 84107 | United States |
|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53705 | United States |
|
| St. Vincent's Sydney | Recruiting | Sydney | New South Wales | Australia |
|
| Princess Alexandra Hospital | Recruiting | Woolloongabba | Queensland | Australia |
|
| Fiona Stanley Hospital | Recruiting | Murdoch | Western Australia | 6150 | Australia |
|
| Pan American Center for Oncology Trials, LLC - Ciudadela | Recruiting | San Juan | 00918 | Puerto Rico |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided