A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer

November 2, 2026 updated by: Janssen Research & Development, LLC

A Phase 3 Randomized, Double-blind, Placebo-controlled Study of JNJ-101556143, a Regulated Induced Proximity Targeting Chimera (RIPTAC™) Therapeutic Plus Best Supportive Care Versus Best Supportive Care in Participants With Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Medical Center
  • United States
    • Texas
      • El Paso, Texas, United States, 79915
        • Recruiting
        • Renovatio Clinical 1
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Renovatio Clinical
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Summit Urology Folio Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Have histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed neuroendocrine carcinoma, large cell neuroendocrine carcinoma, or sarcoma of the prostate is disallowed
  • Progressive metastatic androgen pathway modulation-resistant prostate cancer (mAPMR) defined as having a Prostate-Specific Antigen (PSA) level greater than or equal (>=) 10 nanograms per milliliter (ng/mL) and at least one of the following: (a) PSA progression defined as at least 2 consecutive increases in PSA value over a previous reference value measured at least 1 week apart. (b) Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera on conventional imaging (computed tomography [CT]/magnetic resonance imaging [MRI]) as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) and/or on bone scan per Prostate Cancer Working Group 4 (PCWG4) while on Androgen Deprivation Therapy (ADT) (either surgically [bilateral orchiectomy] or with medication)
  • Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access
  • Prior bilateral orchiectomy or medical castration (receiving ongoing ADT with a Gonadotropin-Releasing Hormone (GnRH) analog [agonist or antagonist]) with castrate level of serum testosterone (less than [<] 50 nanograms per deciliter [ng/dL] or 1.7 nanomoles per liter [nmol/L]) prior to the first dose of trial intervention and must continue this therapy throughout the treatment phase
  • Have discontinued concurrent use of any non-investigational systemic anticancer therapy (that is, cytotoxic chemotherapy, Androgen Receptor Pathway Inhibitor (ARPI), radiation therapy) non-sponsor investigational drugs within 2 weeks or Lutetium-177 Prostate-Specific Membrane Antigen-617 (177^Lu PSMA-617) within 4 weeks prior to randomization and may not have participated in an investigational trial within the sponsor's development program within 6 months prior to randomization
  • Toxicity related to prior anticancer treatment that is deemed clinically relevant must have resolved to common terminology criteria for adverse events (CTCAE) Version 6.0 Grade 1 or better

Exclusion Criteria:

  • Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
  • Suspected or known allergies, hypersensitivity, or intolerance to JNJ-101556143 or its excipients
  • Had major surgery or had significant traumatic injury less than or equal to 28 days of the first dose of trial intervention
  • Spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
  • Solid organ or bone marrow transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JNJ-101556143 + Best Supportive Care

Participants will receive JNJ-101556143 orally once daily along with Best Supportive Care. Treatment will continue until discontinuation criteria are met.
Drug: JNJ-101556143

Participants will receive JNJ-101556143 orally.

Drug: Best Supportive Care

Best supportive care may include palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and clinically indicated palliative procedures.
Placebo Comparator: Placebo + 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

Participants will receive matching placebo orally.

Drug: Best Supportive Care

Best supportive care may include palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and clinically indicated palliative procedures.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 21 months

OS is defined as the time from randomization to date of death from any cause.
Up to 21 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiographic Progression-Free Survival (rPFS)
Time Frame: Up to 21 months

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.
Up to 21 months
Progression-Free Survival (PFS)
Time Frame: Up to 21 months

PFS is defined as the time from randomization until disease progression or death, whichever occurs first.
Up to 21 months
Time to Symptomatic Progression (TSP)
Time Frame: Up to 21 months

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.
Up to 21 months
Time to Skeletal-Related Events (TSRE)
Time Frame: Up to 21 months

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.
Up to 21 months
Time to Pain Progression (TTPP)
Time Frame: Up to 21 months

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.
Up to 21 months
Number of Participants with Treatment-Emergent Adverse Event (TEAE) by Severity
Time Frame: Up to 21 months

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.
Up to 21 months
Number of Participants with Abnormalities in Clinical Laboratory Tests
Time Frame: Up to 21 months

Participants with abnormalities in clinical laboratory tests will be reported.
Up to 21 months
Plasma Concentration of JNJ-101556143
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)

Plasma samples will be analyzed to determine concentrations of JNJ-101556143 using a validated LC-MS/MS method.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 101556143PCR3001
  • 101556143PCR3001 (Other Identifier: Janssen Research & Development, LLC)
  • 2026-527547-18-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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