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New treatment option for Metastatic Hormone-sensitive Prostate Cancer
Official title An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
ClinicalTrials.gov ID: NCT06991556
What this study is testing
What is JSB462?
JSB462 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic hormone-sensitive prostate cancer.
Also referred to as luxdegalutamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2
- Histologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible
- High-volume mHSPC, defined by the presence of ≥1 metastatic visceral non-nodal lesion and/or ≥4 metastatic bone lesions (with at least one lesion...
- Participants must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Ongoing ADT (as defined by prior orchiectomy...
You likely can't join if
- Prior exposure to a second generation ARPI (such as enzalutamide/darolutamide/apalutamide and/or abiraterone) for the treatment of...
- Participants with biochemical recurrence only or those without evidence of metastatic disease by radiological imaging (CT/MRI or bone scan) are not...
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Santa Monica, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Daytona Beach, Florida, United States
- Atlanta, Georgia, United States
- Chicago Ridge, Illinois, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- West Bloomfield, Michigan, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Syracuse, New York, United States
- The Bronx, New York, United States
- Bala-Cynwyd, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Norfolk, Virginia, United States
+ 44 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Santa Monica, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Daytona Beach, Florida, United States; Atlanta, Georgia, United States and 58 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.