Shorter apalutamide or enzalutamide treatment for low-volume, hormone-sensitive metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men with low-volume, de novo metastatic, hormone-sensitive prostate cancer who have completed 12 months of androgen receptor pathway inhibitor (apalutamide or enzalutamide) plus ADT are randomized to either continue ARPI with ADT or stop ARPI after 12 months while remaining on ADT, with the option to restart ARPI if a confirmed PSA rise occurs. Randomization occurs after the first 12 months of therapy and PSA confirmation of progression requires a repeat sample at least four weeks after the initial rise. The trial is designed as a Phase 3 non-inferiority comparison to determine whether a fixed 12-month ARPI strategy provides similar disease control while reducing cumulative toxicity and costs. Imaging for low-volume status may include bone scan/CT or PSMA-PET and eligibility requires ECOG 0–2 and initiation of ADT within six weeks before inclusion.

Why it matters

Who can join: the full rules

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 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.
* ADT initiated within 6 weeks prior to inclusion
* Eastern Cooperative Oncology Group (ECOG) performance scale status of 0, 1 or 2
* Fit for treatment with apalutamide or enzalutamide according to treating physician

Exclusion Criteria:

* 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)
* ADT started more than 6 weeks before inclusion

Where it's running

• Noordwest Ziekenhuisgroep
  Alkmaar, Netherlands 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

Study contacts

• Study coordinator: Dr. N. Beije
• Email: n.beije@erasmusmc.nl
• Phone: +31010 704 0704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.