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

• ClinicalTrials.gov Identifier: NCT04186819
• Recruitment Status: Completed
• First Posted: December 5, 2019
• Last Update Posted: March 17, 2022
• Sponsor: Blue Earth Diagnostics
• Collaborator: Parexel
• Information provided by (Responsible Party): Blue Earth Diagnostics

Tracking Information

• First Submitted Date: November 22, 2019
• First Posted Date: December 5, 2019
• Last Update Posted Date: March 17, 2022
• Actual Study Start Date: February 12, 2020
• Actual Primary Completion Date: June 17, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 2, 2019)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 2, 2019)

• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Positron Emission Tomography (PET) Imaging study

Masking: None (Open Label)
Primary Purpose: Diagnostic

• Condition: Prostate Cancer

Intervention

Drug: rhPSMA-7.3 (18F) Injection

Radioligand for PET CT scanning

Study Arms

Experimental: Patients

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

Intervention: Drug: rhPSMA-7.3 (18F) Injection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 22, 2022): 356
• Original Estimated Enrollment (submitted: December 2, 2019): 300
• Actual Study Completion Date: February 18, 2022
• Actual Primary Completion Date: June 17, 2021 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• 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

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland, Germany, Netherlands, United States

Administrative Information

• NCT Number: NCT04186819
• Other Study ID Numbers: BED-PSMA-301
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Blue Earth Diagnostics
• Original Responsible Party: Same as current
• Current Study Sponsor: Blue Earth Diagnostics
• Original Study Sponsor: Same as current
• Collaborators: Parexel
• Investigators: Not Provided
• PRS Account: Blue Earth Diagnostics
• Verification Date: March 2022