ClinicalTrialsFinder
RecruitingPhase 1Phase 2NCT05413850

Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection

An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer

Sponsor

Blue Earth Therapeutics Ltd

Enrollment

82 participants

Start Date

Jul 20, 2022

Study Type

INTERVENTIONAL

Conditions

Prostate CancerMetastatic Castration-resistant Prostate CancerUrogenital NeoplasmsProstatic NeoplasmsProstatic DiseasesmCRPC

Summary

To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radioactive treatment called lutetium-177 PSMA (177Lu-rhPSMA-10.1) for men with advanced prostate cancer that has spread and is no longer responding to standard hormone therapy. The treatment targets PSMA, a protein found on prostate cancer cells, to deliver radiation directly to the tumor. **You may be eligible if...** - You are male, 18 or older, with prostate cancer confirmed by biopsy - Your testosterone level is very low (castrate levels) from surgery or ongoing hormone injections - You have measurable disease on CT/MRI or bone scan (within 28 days of screening) - Your tumor shows positive PSMA expression on a PSMA PET/CT scan - At least 4 weeks have passed since your last cancer treatment **You may NOT be eligible if...** - Your tumor does not show PSMA expression on scan - You have not achieved castrate testosterone levels - You have serious organ dysfunction or other conditions that make this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLutetium (177Lu) rhPSMA-10.1 Injection

Therapeutic cycles of 177Lu-rhPSMA-10.1

DIAGNOSTIC_TEST18F-rhPSMA-7.3 injection (in phase 1 only)

18F-rhPSMA-7.3 (in phase 1 only) at an administered activity of 296 MBq (8 mCi) for PET/CT scan to ascertain whether the subject has PSMA-positive disease.

Locations(23)

Biogenix Molecular LLC

Miami, Florida, United States

NovaCure Health

Miami, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

XCancer Omaha / Urology Cancer Center

Omaha, Nebraska, United States

Weill Cornell Medicine - New York - Presbyterian Hospital

New York, New York, United States

Jules Bordet Institute

Brussels, Belgium

Saint Luc University Hospital

Brussels, Belgium

University Hospital Ghent

Ghent, Belgium

University Hospital Leuven

Leuven, Belgium

University Hospital Center Sart-Tilman

Liège, Belgium

University Hospital Aachen

Aachen, Germany

Universitätsklinikum Augsburg

Augsburg, Germany

University Hospital Essen

Essen, Germany

Hospital Rechts der Isar

Munich, Germany

Radboud UMC

Nijmegen, Gelderland, Netherlands

Meander Medisch Centrum

Amersfoort, Netherlands

Bristol Hematology and Oncology Center

Bristol, United Kingdom

Beatson West of Scotland Cancer Center

Glasgow, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

James Cook University Hospital

Middlesbrough, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Weston Park

Sheffield, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05413850

Related Trials

Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer

NCT046926751 location

DESTINY-PANTUMOUR04

NCT0712400017 locations

A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer

NCT0700515433 locations

Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System

NCT068073593 locations

A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs

NCT0733644618 locations