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

NCT07260435 | Recruiting Phase 3

• 1 other identifier: EU CT 2023-506698-36
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 26

Brief 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. 1.ADT + continued ARPI (Apalutamide or Enzalutamide)
2. 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Time to clinical progression free survival (cPFS) in both arms.

  To prospectively evaluate whether shortened (12 months) treatment with ARPIs, with retreatment with ARPIs in case of PSA progression (defined according to PSA progression criteria) is non-inferior with respect to clinical progression free survival (boundary of max -10% at 48 months) to continued treatment with ARPI evaluated by comparing time to cPFS (as defined in primary endpoint) in both arms.

  From inclusion to the last day of treatment or moment of progression (whichever occurs first). Subjects will participate for 5 years, after randomization. In total, patients will participate for 6 years.

Study Arms (2)

ADT plus continued ARPI (apalutamide/enzalutamide)

EXPERIMENTAL

Drug: ADT plus continued ARPI

ADT plus only 12 months of ARPI (apalutamide/enzalutamide) with the possibility t

EXPERIMENTAL

Drug: ADT plus only 12 months of ARPI

Interventions

ADT plus only 12 months of ARPI DRUG

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

ADT plus only 12 months of ARPI (apalutamide/enzalutamide) with the possibility t

ADT plus continued ARPI DRUG

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

ADT plus continued ARPI (apalutamide/enzalutamide)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 other than fitting the criteria for high-volume metastatic disease, e.g., four or more bone lesions with one or more lesions in any body structure beyond the spine or pelvis, or visceral disease (non-nodal). This has been assessed by either bone scan and computed tomography (CT), or PSMA-PET scan. Low-volume disease has subsequently been confirmed by the local (multidisciplinary) team after consideration of the available imaging results as per the standard imaging protocol for the site.
• Eastern Cooperative Oncology Group (ECOG) performance scale status of 0, 1 or 2
• Fit for treatment with apalutamide or enzalutamide according to treating physician

You may not qualify if:

• Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
• Other prior malignancy less than or equal to 5 years prior to randomization except for squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
• History of seizures or medications known to lower seizure threshold
• Any other prior treatment for prostate cancer other than ADT (e.g., other next generation anti-androgens or other CYP17 inhibitors, chemotherapy, immunotherapy, or radiopharmaceutical agents)

Sponsors & Collaborators

• Nick Beije: lead
• Stichting Treatmeds: collaborator

Study Sites (26)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

RECRUITING

Meander MC Amersfoort

Amersfoort, Netherlands

NOT YET RECRUITING

Amsterdam Universitair Medisch Centrum

Amsterdam, Netherlands

NOT YET RECRUITING

Antoni van Leeuwenhoek

Amsterdam, Netherlands

NOT YET RECRUITING

Wilhelmina Ziekenhuis Assen

Assen, Netherlands

RECRUITING

Rode Kruis Ziekenhuis

Beverwijk, Netherlands

RECRUITING

Deventer Ziekenhuis

Deventer, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, Netherlands

RECRUITING

Treant Zorggroep

Emmen, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, Netherlands

RECRUITING

Admiraal de Ruyter ziekenhuis

Goes, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, Netherlands

RECRUITING

Spaarne Gasthuis

Haarlem, Netherlands

RECRUITING

Ziekenhuisgroep Twente

Hengelo, Netherlands

RECRUITING

Tergooi MC

Hilversum, Netherlands

NOT YET RECRUITING

Frisius MC Leeuwarden

Leeuwarden, Netherlands

RECRUITING

Maastricht UMC

Maastricht, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

RECRUITING

Laurentius Ziekenhuis

Roermond, Netherlands

RECRUITING

Bravis Ziekenhuis

Roosendaal, Netherlands

RECRUITING

Erasmus mc

Rotterdam, Netherlands

RECRUITING

Fransicus Gasthuis & Vlietland

Rotterdam, Netherlands

RECRUITING

Maasstad Ziekenhuis

Rotterdam, Netherlands

RECRUITING

HagaZiekenhuis

The Hague, Netherlands

RECRUITING

St. Antonius Ziekenhuis

Utrecht, Netherlands

NOT YET RECRUITING

VieCuri Medisch Centrum

Venlo, Netherlands

RECRUITING

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Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Single Person

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Central Study Contacts

Dr. N. Beije

CONTACT

+31010 704 0704; n.beije@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MD PhD

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: February 20, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

NL (26)