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Prostatic NeoplasmsPhase 3NCT07906717

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

A Phase 3 study testing JNJ-101556143 in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 4 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
JNJ-101556143
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
4 sitesin 2 countries
Study dates
29 Oct 2026to 18 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

4 sites in 2 countries

United States3 sites, 3 recruiting

  • Renovatio Clinical 1

    El Paso, Texas, 79915

    Recruiting

  • Summit Urology Folio Clinical Research

    Murray, Utah, 84107

    Recruiting

  • Renovatio Clinical

    The Woodlands, Texas, 77380

    Recruiting

Other trials in United States

Israel1 site, 1 recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Recruiting

Other trials in Israel

About this study

Official title: 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).

Being tested
JNJ-101556143, Placebo, Best Supportive Care
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-101556143Drug

    Participants will receive JNJ-101556143 orally.

  • PlaceboDrug

    Participants will receive matching placebo orally.

  • Best Supportive CareDrug

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

Study groups in NCT07906717
Study groupRoleWhat they receive
JNJ-101556143 + Best Supportive CareExperimentalParticipants will receive JNJ-101556143 orally once daily along with Best Supportive Care. Treatment will continue until discontinuation criteria are met.
Receives: Drug: JNJ-101556143; Drug: Best Supportive Care
Placebo + Best Supportive CarePlacebo comparatorParticipants will receive matching placebo orally once daily along with Best Supportive Care. Treatment will continue until discontinuation criteria are met.
Receives: Drug: Placebo; Drug: Best Supportive Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

    Measured: Up to 21 months

Secondary outcomes (8)

  1. 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.

    Measured: Up to 21 months

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization until disease progression or death, whichever occurs first.

    Measured: Up to 21 months

  3. 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.

    Measured: Up to 21 months

  4. 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.

    Measured: Up to 21 months

  5. 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.

    Measured: Up to 21 months

  6. 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.

    Measured: Up to 21 months

  7. Number of Participants with Abnormalities in Clinical Laboratory Tests

    Participants with abnormalities in clinical laboratory tests will be reported.

    Measured: Up to 21 months

  8. Plasma Concentration of JNJ-101556143

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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2026
  2. Study start29 Oct 2026
  3. Primary completion14 Feb 2028 (estimated)
  4. Study completion18 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07906717
Sponsor's protocol ID
101556143PCR3001
Other IDs
101556143PCR3001, 2026-527547-18-00
Status last verified
Nov 2026
First submitted
26 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JNJ-101556143 in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07906717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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