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Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04186845
Recruitment Status : Completed
First Posted : December 5, 2019
Last Update Posted : March 17, 2022
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Blue Earth Diagnostics

Study Description
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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
Prostate Cancer Drug: rhPSMA-7.3 (18F) Injection Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.
Actual Study Start Date : May 5, 2020
Actual Primary Completion Date : April 9, 2021
Actual Study Completion Date : October 12, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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). [ Time Frame: 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 :
  1. Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. [ Time Frame: 90 days ]
    Kappa statistic for the agreement between blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.

  2. Intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers. [ Time Frame: 90 days ]
    Kappa statistic for the agreement within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.

  3. Number of participants with treatment-related adverse events as classified by MedDRA [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients required to have suspected prostate cancer recurrence based on elevated PSA following prior therapy.
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186845


Locations
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Sponsors and Collaborators
Blue Earth Diagnostics
Parexel
More Information
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Responsible Party: Blue Earth Diagnostics
ClinicalTrials.gov Identifier: NCT04186845    
Other Study ID Numbers: BED-PSMA-302
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Blue Earth Diagnostics:
Recurrent Prostate Cancer
Diagnostic
Prostate Specific Membrane Antigen (PSMA)
Positron Emission Tomography (PET) Scan
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Disease Attributes
Pathologic Processes