Recruiting
Phase 3

JNJ-101556143 with BSC

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07906717

Conditions

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-101556143

Placebo

Best Supportive Care

Study Details

Brief 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). 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).

Conditions

Prostatic Neoplasms

Study ID

NCT07906717

Start date

Oct 29, 2026

Status verified date

Nov, 2026

Completion date

Aug 18, 2028

Anticipated

Primary completion date

Feb 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

JNJ-101556143

Participants will receive JNJ-101556143 orally.

Placebo

Participants will receive matching placebo orally.

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.

Primary outcome measure

  • Overall Survival (OS) [ Time Frame: Up to 21 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Renovatio Clinical 1

Recruiting

El Paso, Texas, United States, 79915

Renovatio Clinical

Recruiting

The Woodlands, Texas, United States, 77380

Summit Urology Folio Clinical Research

Recruiting

Murray, Utah, United States, 84107

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Nov 3, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.