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.
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