Participants
cancers, squamous cell skin cancer, malignancy, intercurrent illness, prostate cancer
CANCERS, SQUAMOUS CELL SKIN CANCER, PROSTATIC ADENOCARCINOMA, ONCOLOGY, LIVER METASTASIS, PROSTATE CANCER
This open-label, single-arm, phase II study was performed at Mount Sinai Medical Center (New York, USA). Patient, were aged 18 or older, had histologically confirmed metastatic prostatic adenocarcinoma; castrate levels of testosterone (<50 ng/dL) on androgen deprivation therapy (ADT) with GnRH agonist to be continued while on study unless patient has previously undergone bilateral orchiectomy; discontinued antiandrogens 30 days prior to baseline PSA; progressed on at least one line of a prior docetaxel–based chemotherapy; had adequate organ and bone marrow function (ANC >1500/μL, platelets >100 000/μL, GFR >30 mL/min, AST and ALT ≤2.5x ULN or ≤5x ULN for patients with liver metastasis); had an ability to swallow oral medications whole; and had an Eastern Cooperative Oncology Group performance status of 0-2. Patients could have received other approved prostate cancer therapies.Key exclusion criteria included prior treatment with platinum chemotherapy, uncontrolled intercurrent illness, medical contraindication to image–guided biopsies, history of prior malignancy (with the exception of adequately treated basal cell or squamous cell skin cancer or other cancers for which the subject has been disease-free for at least 5 years), and radiation therapy to ≥25% of the bone marrow within 30 days prior to being registered for protocol therapy.The research protocol was approved by the Mount Sinai Institutional Review Board (New York, USA). All patients provided written informed consent.