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

NCT07260435 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ADT 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.

DRUG

ADT plus continued ARPI

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

Sponsors & Collaborators

  • Stichting Treatmeds

    collaborator UNKNOWN

  • Nick Beije

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2027-11-30
Completion
2027-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07260435 on ClinicalTrials.gov