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Clinical trial Recruiting at 4 sites Phase 3 Interventional Ages 18 and up Men only

JNJ-101556143 plus Best Supportive Care for metastatic prostate cancer

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

Run by Janssen Research & Development, LLC · NCT07906717 · Data updated 2026-11-12

This study tests whether adding JNJ-101556143 to standard supportive care helps people with metastatic, hormone-resistant prostate cancer live longer than those who receive placebo plus supportive care.

More Prostatic Neoplasms trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment400 (estimated)
SponsorJanssen Research & Development, LLC
Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations4 sites (El Paso, Texas and 3 other locations)
StatusRecruiting
StartedOctober 29, 2026
Main results expectedFebruary 14, 2028
Study endsAugust 18, 2028
Registry record updatedNovember 3, 2026
Trial IDNCT07906717 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with metastatic, androgen pathway modulation-resistant prostate cancer and PSA ≥ 10 ng/mL with evidence of disease progression on imaging or PSA kinetics.

Probably not a fit

Patients whose cancer does not respond to JNJ-101556143 or those who experience intolerable toxicity may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3 interventional trial evaluating JNJ-101556143 in combination with best supportive care versus placebo with best supportive care for metastatic androgen pathway modulation-resistant prostate cancer. Eligible participants have histologically confirmed prostate adenocarcinoma and meet criteria for progressive disease despite androgen pathway–modulating treatment. The trial assesses overall survival as the primary outcome, with randomization to receive the active drug or placebo in addition to standard care. Locations include clinics in El Paso, TX; The Woodlands, TX; and Murray, UT. Lead sponsor is Janssen Research & Development, LLC.

Why it matters

Potential benefit: If successful, participants may experience longer overall survival and potentially better disease control when adding JNJ-101556143 to standard care.

How similar studies have gone: Previous similar approaches in metastatic prostate cancer have shown signals of benefit in some settings, but this specific agent and combination are under evaluation for definitive efficacy.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.