A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy (SPOTLIGHT)

Official 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.

Eligibility Requirements

• Minimum Age: 18 Years
• Sex: MALE

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 391 participants

Study Arms

• Patients (EXPERIMENTAL)
  Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan

Interventions

• DRUG: rhPSMA-7.3 (18F) Injection — Radioligand for PET CT scanning
• DIAGNOSTIC_TEST: Positron emission tomography scan — Imaging scan with radioligand

Primary Outcomes

• Patient-level CDR and Region-level PPV of rhPSMA7.3 (18F) PET for BCR of Prostate Cancer Using Histopathology or Imaging as a SoT (Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan)

Secondary Outcomes

• Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET in Patients Who Had Negative Baseline Conventional Imaging (Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan)
• Patient-level CDR and Region-level PPV of rhPSMA-7.3 (18F) PET for Recurrence in Those Patients With and Without Reference Standard Histopathology Available (Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan)
• Patient-level CDR of rhPSMA-7.3 (18F) PET Stratified by PSA Level (Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan)
• CDR of rhPSMA-7.3 (18F) PET in the Following Regions: Prostate/Prostate Bed, Pelvic Lymph Nodes, Other (Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan)
• Percentage of Patients in Whom rhPSMA-7.3 (18F) PET Imaging Results Changed the Intended Patient Management (Major and Other Changes) (Conventional images within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan)

Eligibility Criteria

Inclusion Criteria:

1. Patient is male and aged \>18 years old.
2. History of localized adenocarcinoma of the prostate with prior curative intent treatment.
3. An elevated PSA, clinically suspicious for biochemically recurrent disease:

   * Following Radical Prostatectomy: PSA \>0.2 ng/mL
   * Following Radiotherapy: nadir +2 ng/mL.
4. Potentially eligible for salvage therapy with curative intent.

Exclusion Criteria:

1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan.
2. Patients currently receiving Androgen Deprivation Therapy (ADT).

Trial Locations

• University of Alabama at Birmingham, Birmingham, Alabama, United States
• Tower Urology, Los Angeles, California, United States
• University of California Irvine Medical Center (UCIMC), Orange, California, United States
• John Wayne Cancer Institute, Santa Monica, California, United States
• Emory University Hospital, Atlanta, Georgia, United States
• Northside Hospital, Austell, Georgia, United States
• Northshore University HealthSystem, Evanston, Illinois, United States
• Loyola University Medical Center, Maywood, Illinois, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland, United States
• Chesapeake Urology Research Associates, Towson, Maryland, United States
• ...and 10 more locations

More Prostate Cancer Trials

View all Prostate Cancer clinical trials