An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Public ClinicalTrials.gov record NCT06991556. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06991556
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 168 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 7, 2025 (Actual)
- Primary completion
- Mar 15, 2032 (Estimated)
- Completion
- Oct 4, 2035 (Estimated)
- Last update posted
- Oct 19, 2026
2025 – 2035
United States locations
- U.S. sites
- 21
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego - Moores Cancer Center | La Jolla | California | 92093-0658 | — |
| Saint Johns Cancer Institute | Santa Monica | California | 90404 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | — |
| Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| Advanced Urology Ins Daytona Beach | Daytona Beach | Florida | 32114 | — |
| Emory University School of Medicine-Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Associated Urological Specialists | Chicago Ridge | Illinois | 60415 | — |
| Mass General Hospital | Boston | Massachusetts | 02114 | — |
| Michigan Institute of Urology | West Bloomfield | Michigan | 48322 | — |
| XCancer Omaha LLC | Omaha | Nebraska | 68130 | — |
| Perlmutter Cancer Centre | New York | New York | 10016 | — |
| Associated Med Professionals of NY | Syracuse | New York | 13210 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Urology San Antonio | San Antonio | Texas | 78229 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Fred Hutch Cancer Research | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06991556, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06991556 live on ClinicalTrials.gov.