Treatment of High-Volume Metastatic Hormone-Sensitive Prostate Cancer (M1) in Male Patients
This protocol addresses male patients with metastatic hormone-sensitive prostate cancer (M1) meeting the CHAARTED high-volume criteria — a subgroup in which disease burden is high and the choice of systemic therapy carries significant clinical weight.
High-volume disease by CHAARTED criteria is defined by the presence of visceral metastases and/or four or more bone metastases, with at least one located beyond the vertebral bodies and pelvic bones. The tumour remains hormone-sensitive at the time of treatment initiation.
Androgen deprivation therapy (ADT) alone is not the recommended approach for this population in patients without contraindications and with sufficient life expectancy to benefit. Current evidence supports ADT combined with additional targeted agents — either as a doublet or, for patients fit for chemotherapy, as a triplet combination.
The selection between available combination regimens depends on patient fitness and individual clinical factors. The complete list of options, sequencing guidance, and dosing details are available in the full protocol.
Treatment goals include PSA decline to nadir and the absence of radiological progression.
References
Offer ADT combined with abiraterone acetate plus prednisone or apalutamide or enzalutamide or rezvilutamide to patients with M1 disease who are fit for the regimen.
Offer ADT combined with darolutamide to patients with M1 disease who are fit for the regimen.
Offer docetaxel only in combination with ADT plus abiraterone or darolutamide to patients with M1 disease who are fit for docetaxel.
Do not offer ADT monotherapy to patients whose first presentation is M1 disease if they have no contraindications for combination therapy and have a sufficient life expectancy to benefit from combination therapy (≥ 1 year) and are willing to accept the increased risk of side effects.