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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rhPSMA-7.3 (18F) Injection
Sponsored by
Blue Earth Diagnostics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Primary Prostate Cancer, Diagnostic, Prostate Specific Membrane Antigen (PSMA), Positron Emission Tomography (PET) Scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Alabama at Birmingham
  • Tower Urology
  • University of California Irvine Medical Center (UCIMC)
  • John Wayne Cancer Institute
  • Emory University Hospital
  • Northside Hospital
  • NorthShore University HealthSystem
  • Loyola University Medical Center
  • Richard L Roudebush VA Medical Center
  • Johns Hopkins University
  • Chesapeake Urology Research Associates
  • Brigham and Women's Hospital
  • University of Michigan, Ann Arbor
  • Karmanos Cancer Institute
  • Washington University School of Medicine
  • The Urologic Institute of Northeastern New York - Community
  • Montefiore Hospital
  • Queens Hospital Center (QHC) - Queens Cancer Center
  • Mount Sinai Faculty Practice Associates
  • Stony Brook University
  • Duke University Medical Center
  • University Hospitals Cleveland Medical Center
  • Cleveland Clinic
  • MidLantic Urology
  • Thomas Jefferson University
  • MD Anderson Hospital
  • Urology San Antonio
  • University of Virginia - Health Science Center
  • Virginia Oncology Associates PC
  • Turku University Hospital
  • Klinik und Poliklinik fur Urologie
  • TU München
  • CWZ
  • Maxima MC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

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

Outcomes

Primary Outcome Measures

Sensitivity of rhPSMA-7.3 (18F)
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.
Specificity of rhPSMA-7.3 (18F)
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

Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers.
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.
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
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.

Full Information

First Posted
November 22, 2019
Last Updated
March 15, 2022
Sponsor
Blue Earth Diagnostics
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT04186819
Brief Title
Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer (LIGHTHOUSE)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
June 17, 2021 (Actual)
Study Completion Date
February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blue Earth Diagnostics
Collaborators
Parexel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Primary Prostate Cancer, Diagnostic, Prostate Specific Membrane Antigen (PSMA), Positron Emission Tomography (PET) Scan

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Positron Emission Tomography (PET) Imaging study
Masking
None (Open Label)
Allocation
N/A
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
Intervention Type
Drug
Intervention Name(s)
rhPSMA-7.3 (18F) Injection
Intervention Description
Radioligand for PET CT scanning
Primary Outcome Measure Information:
Title
Sensitivity of rhPSMA-7.3 (18F)
Description
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.
Time Frame
90 days
Title
Specificity of rhPSMA-7.3 (18F)
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Inter-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers.
Description
Kappa statistic for the agreement between blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.
Time Frame
90 days
Title
Intra-reader agreement of rhPSMA-7.3 (18F) scan interpretation by blinded independent readers.
Description
Kappa statistic for the agreement within blinded independent readers on the interpretation of rhPSMA-7.3 (18F) scans.
Time Frame
90 days
Title
Number of participants with treatment-related adverse events as classified by MedDRA
Description
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.
Time Frame
90 days

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Patients required to have unfavorable intermediate-, high-risk or very high-risk Prostate Cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is male and aged >18 years old. Histologically confirmed adenocarcinoma of the prostate. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND). Exclusion Criteria: Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan. Patients currently receiving, or with a prior history of, Androgen Deprivation Therapy (ADT).
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Tower Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California Irvine Medical Center (UCIMC)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northside Hospital
City
Austell
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Richard L Roudebush VA Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46278
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan, Ann Arbor
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Urologic Institute of Northeastern New York - Community
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Queens Hospital Center (QHC) - Queens Cancer Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Mount Sinai Faculty Practice Associates
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
MidLantic Urology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
MD Anderson Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia - Health Science Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Oncology Associates PC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
Facility Name
Klinik und Poliklinik fur Urologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
TU München
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
CWZ
City
Nijmegen
ZIP/Postal Code
6532
Country
Netherlands
Facility Name
Maxima MC
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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