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RECRUITING Phase 2

An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

NCT06991556 · View on ClinicalTrials.gov ↗

Study Summary

This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated

Interventions

  • DRUG Enzalutamide
  • DRUG Abiraterone
  • DRUG JSB462

Study Locations (20)

California

  • University of California San Diego - Moores Cancer Center — La Jolla
  • Saint Johns Cancer Institute — Santa Monica

Colorado

  • Rocky Mountain Cancer Centers — Denver

Connecticut

  • Yale Cancer Center — New Haven

Georgia

  • Emory University School of Medicine-Winship Cancer Institute — Atlanta

Massachusetts

  • Mass General Hospital — Boston

Nebraska

  • XCancer Omaha LLC — Omaha

New York

  • Perlmutter Cancer Centre — New York

Pennsylvania

  • Fox Chase Cancer Center — Philadelphia

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2025-07-07
Est. Completion 2035-11-07
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06991556

The ClinicalTrials.gov registry entry for NCT06991556 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Metastatic Hormone-sensitive Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which Enzalutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06991556 reports 20 study locations spanning 19 distinct geographic areas — top geographies include California, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06991556 about?

NCT06991556 is a clinical study titled "An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)". This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Horm...

What is the current status of trial NCT06991556?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-07-07. Estimated completion is 2035-11-07.

What conditions does trial NCT06991556 study?

This clinical trial studies the following conditions: Metastatic Hormone-sensitive Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06991556?

The interventions under investigation include: Enzalutamide (DRUG), Abiraterone (DRUG), JSB462 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06991556?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06991556 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial