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Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer (LIGHTHOUSE)

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ClinicalTrials.gov Identifier: NCT04186819
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 Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.

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 : 356 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) Positron Emission Tomography (PET) Ligand in Men With Newly Diagnosed Prostate Cancer
Actual Study Start Date : February 12, 2020
Actual Primary Completion Date : June 17, 2021
Actual Study Completion Date : February 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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. Sensitivity of rhPSMA-7.3 (18F) [ Time Frame: 90 days ]

    Sensitivity of rhPSMA-7.3 (18F) PET for detecting pelvic Lymph Node (LN) metastases compared to surgical pathology on a patient level.

    At least one positive pelvic LN (N1) on the PET scan and one positive LN (N1) as determined by histopathology (pN1) on the same side of the pelvis (Left or Right) will be counted a True Positive at the patient level.


  2. Specificity of rhPSMA-7.3 (18F) [ Time Frame: 90 days ]

    Specificity of rhPSMA-7.3 (18F) PET for detecting pelvic Lymph Node (LN) metastases compared to surgical pathology on a patient level.

    At least one positive pelvic LN (N1) on the PET scan and one positive LN (N1) as determined by histopathology (pN1) on the same side of the pelvis (Left or Right) will be counted a True Positive at the patient level.



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 unfavorable intermediate-, high-risk or very high-risk Prostate Cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is male and aged >18 years old.
  2. Histologically confirmed adenocarcinoma of the prostate.
  3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).

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, or with a prior history of, 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): NCT04186819


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: NCT04186819    
Other Study ID Numbers: BED-PSMA-301
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Primary Prostate Cancer
Diagnostic
Prostate Specific Membrane Antigen (PSMA)
Positron Emission Tomography (PET) Scan
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases