Testing JNJ-101556143 in men with advanced prostate cancer that no longer responds to hormone therapy

Is this trial a fit for you?

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 2 interventional trial evaluating the activity of JNJ-101556143 in participants with metastatic androgen pathway modulation-resistant prostate cancer. Eligible patients have histologically confirmed prostate adenocarcinoma and evidence of disease progression despite hormone therapies, including rising PSA or new lesions on imaging. Participants will receive JNJ-101556143 and will be monitored for tumor response and safety outcomes. The trial focuses on measuring overall response as the primary efficacy signal, defined by changes in tumor size or disappearance according to standard criteria. Locations include sites in Florida, Illinois, and Indiana, with Janssen as the lead sponsor.

Why it matters

Who can join: the full rules

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). Local-regional disease including invasive disease of rectum, bladder, pelvis is allowed as long as participant has a current or past history of distant metastasis (M1 disease). Participants in Part 1 must have measurable disease per RECIST v1.1 by conventional imaging with CT or MRI (chest, abdomen, and pelvis) and/or Technetium-99\^m (99\^mTc) bone scan confirmed by Blinded Independent Central Review (BICR) at the time of screening
* 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) within 2 weeks or Lutetium-177 Prostate-Specific Membrane Antigen-617 (177\^Lu PSMA-617) within 6 weeks prior to first dose of trial intervention, or any investigational drugs within 3 months of first dose of trial intervention
* 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. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate
* 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

• Advanced Urology Institute
  Largo, Florida, United States Recruiting
• Associated Urological Specialists
  Chicago Ridge, Illinois, United States Recruiting
• Urology of Indiana
  Carmel, Indiana, United States Recruiting
• Southern Urology LLC
  Lafayette, Louisiana, United States Recruiting
• Greater Boston Urology
  Plymouth, Massachusetts, United States Recruiting
• Associated Medical Professionals
  Syracuse, New York, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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

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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.