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NCT06991556 · ClinicalTrials.gov registry record · Phase 2
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
A Phase 2 study of Metastatic Hormone-sensitive Prostate Cancer, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT06991556: Recruiting Phase 2 study of Metastatic Hormone-sensitive Prostate Cancer, sponsored by Novartis Pharmaceuticals.
NCT06991556 is a Phase 2 study of Metastatic Hormone-sensitive Prostate Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 150 participants, below the 674-participant average among 5 other Metastatic Hormone-sensitive Prostate Cancer trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 19 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06991556, a Phase 2 study of Metastatic Hormone-sensitive Prostate Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
Prostate Specific Antigen 90 (PSA90) Rate is defined as the proportion of participants who achieve a ≥90% decrease in PSA from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-07-07 |
| Est. Completion | 2035-11-07 |
| Phase | Phase 2 |
What NCT06991556 shows while recruiting
NCT06991556 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 674-participant average among 5 other Metastatic Hormone-sensitive Prostate Cancer trials with a reported enrollment target (78% lower).
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.
NCT06991556 names 20 study sites across 19 states, led by California, Colorado, Connecticut.
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.
What interventions are being tested in trial NCT06991556?
The interventions under investigation include: Enzalutamide (DRUG), Abiraterone (DRUG), JSB462 (DRUG).
Who is sponsoring clinical trial NCT06991556?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
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