RecruitingPhase 1NCT06531499

A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study

A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer


Sponsor

Novartis Pharmaceuticals

Enrollment

106 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radioactive drug called lutetium-177 (Lu-177 PSMA) in men with prostate cancer that has spread and stopped responding to hormone therapy — but who have not yet received chemotherapy. Researchers want to understand how the drug travels through the body and what dose is safe for longer-term use. **You may be eligible if...** - You are 18 or older and have prostate cancer confirmed by biopsy - Your cancer has spread to at least one area on a scan - Your cancer shows a specific protein called PSMA on a special PET scan - Your testosterone is at castrate levels (very low) from medication or surgery - Your cancer progressed after one type of hormone-blocking pill (like enzalutamide or abiraterone) - Your kidneys are working reasonably well **You may NOT be eligible if...** - You have previously received chemotherapy for prostate cancer - You have had any prior radioligand therapy or certain other radioactive treatments - You have had a heart attack or serious heart condition in the past 6 months - You have another active cancer affecting your life expectancy - You have serious kidney disease 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.

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Interventions

DRUGAAA617

\[177Lu\]Lu-PSMA-617 will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%), every 6 weeks for up to 12 cycles.

DRUGGonadotropin-releasing hormone (GnRH) analogues

Anatomical Therapeutic Chemical \[ATC\] code L02AE

DRUGGonadotropin-releasing hormone (GnRH) antagonists

Degarelix, Relugolix


Locations(21)

University of California LA

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Wash U School of Medicine

St Louis, Missouri, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Wuppertal, North Rhine-Westphalia, Germany

Novartis Investigative Site

Aachen, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Rostock, Germany

Novartis Investigative Site

Nijmegen, Gelderland, Netherlands

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Novartis Investigative Site

Majadahonda, Madrid, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Bellinzona, Switzerland

Novartis Investigative Site

Bern, Switzerland

Novartis Investigative Site

Sutton, Surrey, United Kingdom

Novartis Investigative Site

Birmingham, West Midlands, United Kingdom

Novartis Investigative Site

Glasgow, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06531499


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