RecruitingPhase 3NCT07260435

Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate Cancer

Apa/Enza Short Study: Shortened 12 Months Duration of Androgen Receptor Signaling Agent in Combination With Androgen Deprivation Therapy in Patients With Low Volume Castration-sensitive Prostate Cancer: a Randomized Nationwide Study

Sponsor

Nick Beije

Enrollment

400 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

The goal of this clinical trial is to evaluate the outcomes of a shorter treatment duration (12 months) with an androgen receptor pathway inhibitor (ARPI), in this study Apalutamide or Enzalutamide, in patients with low-volume, hormone-sensitive metastatic prostate cancer (mCSPC), with the possibility to restart treatment if needed. The main research question is whether discontinuation of ARPI therapy after 12 months, with the option to restart treatment upon disease progression, is non-inferior to continued ARPI therapy, potentially reducing toxicity and costs. Eligible patients will be randomized after completing 12 months of ARPI treatment, to one of the following two arms: 1. ADT + continued ARPI (Apalutamide or Enzalutamide) 2. ADT + ARPI discontinued after 12 months, with the option to resume ARPI in case of a confirmed PSA rise. The confirmatory PSA sample must be obtained at least 4 weeks after the initial rise. This study aims to minimize toxicity associated with prolonged use of ARPIs in patients with low-volume, hormone-sensitive metastatic prostate cancer.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a shorter course of androgen receptor pathway inhibitor therapy — specifically apalutamide or enzalutamide — is effective and safe for men with low-volume metastatic prostate cancer that has not yet been surgically castrated (castration-sensitive). **You may be eligible if...** - You are male and 18 or older - You have a confirmed diagnosis of prostate cancer spread to distant sites (metastatic) - Your metastatic disease is low-volume (fewer than 4 bone lesions and no organs involved) - Your disease is newly diagnosed or has not yet been treated with hormone therapy **You may NOT be eligible if...** - You have high-volume metastatic disease (4 or more bone lesions with lesions beyond spine/pelvis, or organ spread) - You have previously received hormone therapy or chemotherapy for prostate cancer - You have significant heart or liver problems 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

DRUGADT plus only 12 months of ARPI

ADT plus only 12 months of ARPI (apalutamide/enzalutamide) with the possibility to resume treatment with ARSI in case of a confirmed PSA rise.

DRUGADT plus continued ARPI

ADT plus continued ARPI (apalutamide/enzalutamide) to the moment of progression

Locations(26)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Meander MC Amersfoort

Amersfoort, Netherlands

Amsterdam Universitair Medisch Centrum

Amsterdam, Netherlands

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Wilhelmina Ziekenhuis Assen

Assen, Netherlands

Rode Kruis Ziekenhuis

Beverwijk, Netherlands

Deventer Ziekenhuis

Deventer, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Treant Zorggroep

Emmen, Netherlands

Medisch Spectrum Twente

Enschede, Netherlands

Admiraal de Ruyter ziekenhuis

Goes, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Spaarne Gasthuis

Haarlem, Netherlands

Ziekenhuisgroep Twente

Hengelo, Netherlands

Tergooi MC

Hilversum, Netherlands

Frisius MC Leeuwarden

Leeuwarden, Netherlands

Maastricht UMC

Maastricht, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Laurentius Ziekenhuis

Roermond, Netherlands

Bravis Ziekenhuis

Roosendaal, Netherlands

Erasmus mc

Rotterdam, Netherlands

Fransicus Gasthuis & Vlietland

Rotterdam, Netherlands

Maasstad Ziekenhuis

Rotterdam, Netherlands

HagaZiekenhuis

The Hague, Netherlands

St. Antonius Ziekenhuis

Utrecht, Netherlands

VieCuri Medisch Centrum

Venlo, Netherlands

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NCT07260435

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