RecruitingPhase 3NCT06496581

Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)

A Randomized Phase III Trial Evaluating the Efficacy and Safety of Standard of Care +/- 177Lu-PSMA617 in de Novo Metastatic Hormone-sensitive Prostate Cancer Patients Having a PSA≥0.2 ng/mL at 6-8 Months After Systemic Treatment Initiation


Sponsor

UNICANCER

Enrollment

500 participants

Start Date

Sep 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

PEACE-6 Poor Responders is an international, multicenter, open-label, controlled, randomized, phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when administered on top of the ongoing standard systemic treatment compared to standard systemic treatment alone in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC) who do not present with a satisfactory response characterized by a serum prostatic specific antigen (PSA) level of ≥ 0.2 ng/mL at 6 to 8 months after systemic treatment initiation for mHSPC (i.e. poor responders) in the absence of evidence of cancer progression (including a rising PSA level).


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a targeted radioactive drug called lutetium-177 PSMA-617 (also known as Pluvicto) to standard hormone therapy can improve outcomes in men newly diagnosed with advanced, hormone-sensitive prostate cancer who are not responding well to initial hormone treatment. **You may be eligible if...** - You are 18 or older and have been newly diagnosed with metastatic (spread) prostate cancer that still responds to hormone therapy - Your PSA (prostate-specific antigen) level is not dropping well enough after starting standard treatment - Your PSMA PET scan shows the cancer can be targeted with this drug - Your life expectancy is more than 6 months and general health score (ECOG) is 0–2 **You may NOT be eligible if...** - You have previously received hormone therapy for prostate cancer (except for a short window) - Your PSMA scan does not show adequate uptake - You have serious kidney, liver, or bone marrow problems - You have already received lutetium-based therapies 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

DRUG177Lu-PMSA-617

Once every 6 weeks, 7400 MBq 177Lu-PMSA-617 will be administered for up to a total of 4 cycles.

DRUGStandard of Care

ADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be administrated according to the standard of care


Locations(25)

Institut de Cancérologie de l'Ouest

Angers, France

Institut Bergonié

Bordeaux, France

CHRU Brest

Brest, France

Centre Francois Baclesse

Caen, France

CHU Henri Mondor

Créteil, France

Centre Georges-François Leclerc

Dijon, France

CHU Grenoble

Grenoble, France

Centre Léon Berard

Lyon, France

Institut Paoli-Calmettes

Marseille, France

CHRU Nancy

Nancy, France

Centre Antoine Lacassagne

Nice, France

Hôpital Cochin

Paris, France

Hôpital Saint Louis

Paris, France

Institut Curie

Paris, France

Centre Eugène Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

CHU Rouen

Rouen, France

Institut Curie

Saint-Cloud, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

CHU Saint Etienne

Saint-Priest-en-Jarez, France

ICANS

Strasbourg, France

IUCT Oncopole

Toulouse, France

CHRU Tours

Tours, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

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NCT06496581


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