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

Recruiting Phase 3 Interventional Study
Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
400 (estimated)
Sponsor
Nick Beije · Other
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About This Trial
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 th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male and ≥18 years of age * Capable of understanding and complying with protocol requirements and able to understand and sign the informed consent form * Histological diagnosis of prostate adenocarcinoma * Low volume de novo metastatic disease (M1a or M1b) defined as anything …
Contacts

Dr. N. Beije

+31010 704 0704

n.beije@erasmusmc.nl

CONTACT