Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT)
Study Details
Study Description
Brief Summary
A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Patients Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan |
Drug: rhPSMA-7.3 (18F) Injection
Radioligand for PET CT scanning
|
Outcome Measures
Primary Outcome Measures
- Positive Predictive Value (PPV) of rhPSMA-7.3 (18F) PET on a patient level using histopathology or confirmatory imaging as a Standard of Truth (SoT). [90 days]
PPV (defined as true positive [TP]/{TP+false positive [FP]}) of rhPSMA-7.3 (18F) PET using histopathology or confirmatory imaging as a Standard of Truth (SoT).
Secondary Outcome Measures
- Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. [90 days]
Kappa statistic for the agreement between blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.
- Intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. [90 days]
Kappa statistic for the agreement within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.
- Number of participants with treatment-related adverse events as classified by MedDRA [90 days]
Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F-rhPSMA-7.3 throughout the study period.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is male and aged >18 years old.
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History of localized adenocarcinoma of the prostate with prior curative intent treatment.
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An elevated PSA, clinically suspicious for biochemically recurrent disease:
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Following Radical Prostatectomy: PSA >0.2 ng/mL
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Following Radiotherapy: nadir +2 ng/mL.
- Potentially eligible for salvage therapy with curative intent.
Exclusion Criteria:
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Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
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Patients currently receiving Androgen Deprivation Therapy (ADT).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
2 | Tower Urology | Los Angeles | California | United States | 90048 |
3 | University of California Irvine Medical Center (UCIMC) | Orange | California | United States | 92868 |
4 | John Wayne Cancer Institute | Santa Monica | California | United States | 90403 |
5 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
6 | Northside Hospital | Austell | Georgia | United States | 30342 |
7 | Northshore University HealthSystem | Evanston | Illinois | United States | 60201 |
8 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
9 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
10 | Chesapeake Urology Research Associates | Towson | Maryland | United States | 21204 |
11 | University of Michigan Ann Arbor | Ann Arbor | Michigan | United States | 48109 |
12 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
13 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
14 | Montefiore Hospital | Bronx | New York | United States | 10461 |
15 | Queens Hospital Center (QHC - Queens Cancer Center | Jamaica | New York | United States | 11432 |
16 | Mount Sinai Faculty Practice Associates | New York | New York | United States | 10029 |
17 | Stony Brook University | Stony Brook | New York | United States | 11794 |
18 | Duke University Medical Center | Durham | North Carolina | United States | 27701 |
19 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
20 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
21 | MidLantic Urology | Philadelphia | Pennsylvania | United States | 19004 |
22 | MD Anderson Hospital | Houston | Texas | United States | 77054 |
23 | Urology San Antonio | San Antonio | Texas | United States | 78229 |
24 | University of Virginia - Health Science Center | Charlottesville | Virginia | United States | 22908 |
25 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
26 | Turku University Hospital | Turku | Finland | FI-20520 | |
27 | CWZ | Nijmegen | Netherlands | 6532 | |
28 | Maxima MC | Veldhoven | Netherlands | 5504 DB |
Sponsors and Collaborators
- Blue Earth Diagnostics
- Parexel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BED-PSMA-302