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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04186819

Studienbeginn:
Februar 2020

Letztes Update:
22.01.2021

Wirkstoff:
rhPSMA-7.3 (18F) Injection

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Blue Earth Diagnostics

Collaborator:
Parexel

Kontakt

Studienlocations (3 von 31)

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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).

Studien-Rationale

Primary outcome:

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:

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.

Geprüfte Regime

  • rhPSMA-7.3 (18F) Injection:
    Radioligand for PET CT scanning

Quelle: ClinicalTrials.gov


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