GUARD-QUANTUM is a prospective, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study. The rationale behind studying this combination lies in the potential additive or synergistic benefits that may arise from concurrently targeting androgen receptor signaling pathways and bone metastases.
Patients must be fully informed about the study and sign the informed consent form (ICF) before any study specific assessment.
Patients ≥18 years old.
ECOG performance status of 0 to 2 and Charlson score ≤ 3 prior to study entry, after docetaxel.
Patients with histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
Presence of tumor lesion in central nervous system through radiologically confirmed diagnosis.
Prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin, in-situ carcinoma or low-grade superficial bladder cancer, or the patient has been free of malignancy for a period of 3 years prior to inclusion).
Patients experiencing progression during previous ADT or meeting criteria for castration resistant prostate cancer (CRPC).
External irradiation, brachytherapy, or local treatment (including radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.) within 4 weeks prior to the first dose of study treatment.
Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Lead sponsor
Bayer
Collaborator
MFAR
Collaborator