A Phase 3 Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants with Low-Volume mHSPC
- Conditions
- ow-volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC)MedDRA version: 18.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-000735-32-RO
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 1000
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine if the addition of JNJ-56021927 to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or OS for subjects with low-volume mHSPC.;Secondary Objective: *To evaluate clinically relevant improvements with addition of JNJ-56021927 to ADT including delays in pain progression and opioid use for prostate cancer, skeletal-related events, and the need for cytotoxic chemotherapy<br>*To characterize the safety of adding JNJ-56021927 to ADT in subjects with low-volume mHSPC <br>*To characterize the population pharmacokinetics (PK) and pharmacodynamics (PD) of JNJ-56021927<br>*To evaluate the concentration of leuprolide and assess the PD effect of leuprolide on testosterone concentrations when used alone or in combination with JNJ-56021927;Primary end point(s): - Radiographic Progression-Free Survival (rPFS)<br>- Overall Survival (OS);Timepoint(s) of evaluation of this end point: - Up to 76 Months<br>- Up to 76 Months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Time to Pain Progression<br>- Time to Skeletal-Related Event (SRE)<br>- Time to Chronic Opioid Use<br>- Time to Initiation of Cytotoxic Chemotherapy;Timepoint(s) of evaluation of this end point: - Up to 76 Months<br>- Up to 76 Months<br>- Up to 76 Months<br>- Up to 76 Months