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

Janssen-Cilag International NV0 个研究点目标入组 1,000 人开始时间: 2016年2月16日最近更新: 2016年3月14日

适应症

试验速览

暂无简介。

•- Adenocarcinoma of prostate; if diagnosed greater than or equal to (>=) 5 years from randomization, histologic evidence of prostate adenocarcinoma from a metastatic lesion is required
•- 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;
•d) 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;
•e) 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; f) May have received radiation therapy or prostatectomy as definitive therapy
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 600
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 400

•- 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