A multimodal approach in patients with mHSPC. A pragmatic randomized trial of Apalutamide plus androgen deprivation therapy (ADT).
Principal Investigator
Dott.ssa Alessandra Mosca
Contact Information for Access
Phase
FASE III
Status
ATTIVO
Objective of the study
To determine whether treatment with Apalutamide in combination with androgen-deprivation therapy (ADT) for 6 months, followed by locoregional treatment with radiation therapy or radical prostatectomy, has better efficacy than medical treatment with Apalutamide plus ADT alone in terms of radiographic progression-free survival (rPFS) in patients with hormone-sensitive prostate adenocarcinoma and low-volume metastatic disease.
ClinicalTrials.gov ID: NCT05649943
Sponsor: IRCCS National Cancer Institute Foundation, Milan
Pathologies
Male urologic cancers (urological tumors)
Medication
Apalutamide + local treatment in hormone-sensitive metastatic prostate cancer.
Who is eligible to participate in the study?
Eligible patients are adults (≥18 years of age) with histologically confirmed prostate adenocarcinoma, low-volume metastatic disease (<3 secondary lesions, at least one of which is a bone metastasis documented by imaging), and an ECOG Performance Status of ≤2.
Patients must not have received prior systemic or local treatment for prostate cancer (with the exception of androgen deprivation therapy lasting ≤3 months or TURP performed for decongestive purposes) and must demonstrate adequate organ function as evidenced by laboratory tests.
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