Prostate Cancer
Conditions
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. 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.
Interventions
DRUGADT 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.
DRUGADT plus continued ARPI
ADT plus continued ARPI (apalutamide/enzalutamide) to the moment of progression
Sponsors
Stichting Treatmeds
Nick Beije
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical progression free survival (cPFS) 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. | 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. |
Countries
Netherlands
Contacts
Primary ContactDr. N. Beije
Outcome results
None listed