Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate Cancer
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
You may not be 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)
ADT started more than 6 weeks before inclusion
Clareo Health | Apa/Enza-short Study: Shorter Treatment With Androgen Receptor Pathway Inhibitor in Patients With Low-volume Metastatic Castration-sensitive Prostate Cancer
