A Phase 3 interventional study of JNJ-101556143 and Placebo in Prostatic Neoplasms, sponsored by Janssen Research & Development, LLC. Recruiting at 4 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate how well JNJ-101556143 plus Best Supportive Care (BSC) improves overall survival (the length of time a participant remains alive) compared with placebo plus BSC in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR). mAPMR is an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone treatments designed to block male hormones (androgens).
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive JNJ-101556143 orally once daily along with Best Supportive Care. Treatment will continue until discontinuation criteria are met.
Drug: JNJ-101556143 · Drug: Best Supportive Care
Participants will receive matching placebo orally once daily along with Best Supportive Care. Treatment will continue until discontinuation criteria are met.
Drug: Placebo · Drug: Best Supportive Care
Participants will receive JNJ-101556143 orally.
Participants will receive matching placebo orally.
Best supportive care may include palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and clinically indicated palliative procedures.
Overall Survival (OS)
OS is defined as the time from randomization to date of death from any cause.
Time frame: Up to 21 months
Radiographic Progression-Free Survival (rPFS)
rPFS is defined as the time from the date of randomization until the date of radiographic disease progression or death, whichever comes first as per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) and Prostate Cancer Working Group 4 (PCWG4) criteria.
Time frame: Up to 21 months
Progression-Free Survival (PFS)
PFS is defined as the time from randomization until disease progression or death, whichever occurs first.
Time frame: Up to 21 months
Time to Symptomatic Progression (TSP)
TSP is defined as the time from the date of randomization to the date of the first occurrence of any of the following: The use of external beam radiation for palliative treatment; need for tumor-related orthopedic surgical intervention; other cancer-related procedures; cancer-related morbid events and initiation of a new systemic anticancer therapy because of cancer symptoms.
Time frame: Up to 21 months
Time to Skeletal-Related Events (TSRE)
TSRE is defined as the time from the date of randomization to the date of the first occurrence of any of the following (whichever occurs first): * The use of external beam radiation therapy to relieve skeletal symptoms. * The need for tumor-related orthopedic surgical intervention. * The occurrence of new bone fractures (cancer-related; vertebral or non-vertebral). * The occurrence of tumor-related spinal cord compression.
Time frame: Up to 21 months
Time to Pain Progression (TTPP)
TTPP is defined as the time from the date of randomization to first observation of pain progression. Pain progression is defined as an increase of \>=2 points from baseline in the BPI-SF worst pain intensity (item 3) observed at 2 consecutive evaluations \>=3 weeks apart with no decrease in analgesic dose.
Time frame: Up to 21 months
Number of Participants with Treatment-Emergent Adverse Event (TEAE) by Severity
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale defined as Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to 21 months
Number of Participants with Abnormalities in Clinical Laboratory Tests
Participants with abnormalities in clinical laboratory tests will be reported.
Time frame: Up to 21 months
Plasma Concentration of JNJ-101556143
Plasma samples will be analyzed to determine concentrations of JNJ-101556143 using a validated LC-MS/MS method.
Time frame: Pre-dose for Cycles 1 to 4; 2 to 3 hours and 4 to 8 hours Post-dose from Cycles 1 to 2 (each cycle duration is 28 days)
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Androgen Receptor-targeting Regulated Induced Proximity Targeting Chimera HLD-0915
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