A Study of JNJ-56021927 Plus AndrogenDeprivation Therapy (ADT) Versus ADT inParticipants with Low-Volume mHSPC

Phase 3

• Conditions: Prostate Cancer; Mlignant Neoplasm of Prostate; Prostatic Neoplasm; C04.588.945.440.770

• Registration Number: RBR-6txnfv
• Lead Sponsor: Fundação Pio XII - Hospital de Câncer de Barretos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic Progression-Free Survival (rPFS); up to 76 months; The rPFS is defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurs first.