56021927PCR3002 - A Phase 3 Randomized, Placebocontrolled, Double-blind Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects with Low-volume Metastatic Hormonesensitive Prostate Cancer (mHSPC)

Fundação Pio XII - Hospital de Câncer de Barretos0 个研究点开始时间: 2016年4月1日最近更新: 2023年5月29日

研究概览

暂无简介。

•Adenocarcinoma of prostate; if diagnosed greater than or equal to (>=) 5 years from randomization; Metastatic disease documented by >= 2 bone lesions on 99mTc bone scan; Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0, 1, or 2; Allowed prior treatment for prostate cancer: a) Maximum of 1 course of radiation or surgical intervention; b) Up to 6 cycles of docetaxel for low-volume disease with the last dose within 2 months of randomization; c) Must not have experienced disease progression between the last dose of docetaxel and Screening; Participants who did not receive prior docetaxel may have received less than or equal to (<=) 3 months of ADT in the metastatic disease setting prior to randomization. Participants who received prior docetaxel may have received <= 6 months ADT in the metastatic setting prior to randomization; May also have received up to 6 months of GnRHa in the adjuvant or neo-adjuvant setting as long as it was completed greater than (>)1 year prior to randomization; May have received radiation therapy or prostatectomy as definitive therapy

•Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate - Known brain metastases - Lymph nodes as only site of metastasis – Visceral metastasis observed on computed tomography (CT)/magnetic resonance imaging (MRI) or >= 4 bone lesions on 99mTc bone scan with at least 1 lesion beyond the pelvis or vertebral column - Any prior malignancy within 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer - Prior treatment with other second generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer - History of seizures or medications known to lower seizure threshold

发起方

Fundação Pio XII - Hospital de Câncer de Barretos