Actively Recruiting
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)
Led by Novartis Pharmaceuticals · Updated on 2026-06-02
150
Participants Needed
67
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once daily doses together with abiraterone, compared with an androgen receptor pathway inhibitor (either abiraterone or enzalutamide) in adult males with metastatic hormone-sensitive prostate cancer (mHSPC). This Phase II trial aims to assess the efficacy, safety, tolerability, and pharmacokinetics of these treatments to select the recommended dose for a future Phase III study. Participants undergo a screening period of 28 days, followed by a treatment period where JSB462 is given orally once daily at either 100 mg or 300 mg continuously until disease progression, unacceptable side effects, death, or decision to stop treatment. Abiraterone (1000 mg daily) or enzalutamide (160 mg daily) is also given orally and continuously during this period. After stopping treatment, participants have a 30-day safety follow-up visit and may receive further therapies as needed. The study then continues with long-term follow-up to collect safety, efficacy, and survival data. During the trial, participants will have regular assessments including monitoring of prostate specific antigen (PSA) levels, imaging scans, adverse event tracking, dose adjustments, and pharmacokinetic sampling. Researchers will evaluate outcomes such as PSA response rates, progression-free survival, overall survival, response rates, and patient-reported outcomes. The total follow-up for safety and efficacy outcomes may last up to approximately 83 months, providing extended monitoring of treatment effects and participant health.
CONDITIONS
Brief Title
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Histologically confirmed adenocarcinoma of the prostate (no mixed neuroendocrine histology)
- High-volume metastatic hormone-sensitive prostate cancer, defined by at least one metastatic visceral non-nodal lesion and/or four or more metastatic bone lesions with at least one lesion outside the vertebral column or pelvis
- Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)
- Ongoing androgen deprivation therapy for up to 90 days allowed if PSA zero is not achieved prior to randomization
You will not qualify if you...
- Prior treatment with second generation androgen receptor pathway inhibitors (enzalutamide, darolutamide, apalutamide, or abiraterone) for advanced/metastatic disease
- Biochemical recurrence only without radiological evidence of metastatic disease
- Mixed histology including neuroendocrine prostate cancer
- Prior taxane chemotherapy or radioligand therapy for localized prostate cancer unless last dose was more than 12 months prior
- First generation androgen receptor pathway inhibitors allowed only if administered for 14 days or less and last dose at least 7 days before randomization
- Other exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive daily oral doses of JSB462 in combination with abiraterone or abiraterone alone continuously until disease progression, unacceptable toxicities, death, participant decision, or investigator decision.
Visits as scheduled during treatment period
Duration - Approximately 30 days
After stopping treatment, participants are followed for safety monitoring.
At least 1 follow-up visit (in-person)
Duration - Up to end of study
Participants are followed long-term to collect safety, efficacy, and survival information until the end of the study.
Visits as needed during long-term follow-up
Trial Site Locations
Total: 67 locations
1
University of California San Diego - Moores Cancer Center
La Jolla, California, United States, 92093-0658
Actively Recruiting
2
Saint Johns Cancer Institute
Santa Monica, California, United States, 90404
Actively Recruiting
3
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Actively Recruiting
4
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
5
Advanced Urology Ins Daytona Beach
Daytona Beach, Florida, United States, 32114
Actively Recruiting
6
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Associated Urological Specialists
Chicago Ridge, Illinois, United States, 60415
Actively Recruiting
8
American Oncology Partners PA Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Actively Recruiting
9
Mass General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
10
Michigan Institute of Urology
West Bloomfield, Michigan, United States, 48322
Actively Recruiting
11
XCancer Omaha LLC
Omaha, Nebraska, United States, 68130
Actively Recruiting
12
Perlmutter Cancer Centre
New York, New York, United States, 10016
Actively Recruiting
13
Associated Med Professionals of NY
Syracuse, New York, United States, 13210
Actively Recruiting
14
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
15
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
16
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
17
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
18
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
19
Urology San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
20
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
21
Fred Hutch Cancer Research
Seattle, Washington, United States, 98109
Actively Recruiting
22
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
Actively Recruiting
23
Novartis Investigative Site
Clayton, Victoria, Australia, 3168
Actively Recruiting
24
Novartis Investigative Site
Fortaleza, Ceará, Brazil, 60140-025
Actively Recruiting
25
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01221-020
Actively Recruiting
26
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
27
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
28
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
29
Novartis Investigative Site
Beijing, Chaoyang, China, 100021
Actively Recruiting
30
Novartis Investigative Site
Beijing, China, 100034
Actively Recruiting
31
Novartis Investigative Site
Brno, Czechia, 656 53
Actively Recruiting
32
Novartis Investigative Site
Olomouc, Czechia, 779 00
Actively Recruiting
33
Novartis Investigative Site
Prague, Czechia, 150 06
Actively Recruiting
34
Novartis Investigative Site
Nice, Alpes Maritimes, France, 06189
Actively Recruiting
35
Novartis Investigative Site
Marseille, France, 13273
Actively Recruiting
36
Novartis Investigative Site
Quint-Fonsegrives, France, 31130
Actively Recruiting
37
Novartis Investigative Site
Suresnes, France, 92150
Actively Recruiting
38
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
39
Novartis Investigative Site
Hamburg, Germany, 20246
Actively Recruiting
40
Novartis Investigative Site
Lübeck, Germany, 23538
Actively Recruiting
41
Novartis Investigative Site
Nürtingen, Germany, 72622
Actively Recruiting
42
Novartis Investigative Site
Asti, AT, Italy, 14100
Actively Recruiting
43
Novartis Investigative Site
Padova, PD, Italy, 35128
Actively Recruiting
44
Novartis Investigative Site
Trento, TN, Italy, 38122
Actively Recruiting
45
Novartis Investigative Site
Orbassano, TO, Italy, 10043
Actively Recruiting
46
Novartis Investigative Site
Verona, VR, Italy, 37134
Actively Recruiting
47
Novartis Investigative Site
Zwolle, Overijssel, Netherlands, 8025 AB
Actively Recruiting
48
Novartis Investigative Site
Dordrecht, South Holland, Netherlands, 3318 AT
Actively Recruiting
49
Novartis Investigative Site
Hoofddorp, Netherlands, 2134 TM
Actively Recruiting
50
Novartis Investigative Site
Schiedam, Netherlands, 3118 JH
Actively Recruiting
51
Novartis Investigative Site
Kielce, Poland, 25-640
Actively Recruiting
52
Novartis Investigative Site
Olsztyn, Poland, 10-288
Actively Recruiting
53
Novartis Investigative Site
Oświęcim, Poland, 32-600
Actively Recruiting
54
Novartis Investigative Site
Skorzewo, Poland, 60-185
Actively Recruiting
55
Novartis Investigative Site
Singapore, Singapore, 119074
Actively Recruiting
56
Novartis Investigative Site
Singapore, Singapore, 169608
Actively Recruiting
57
Novartis Investigative Site
Singapore, Singapore, S308433
Actively Recruiting
58
Novartis Investigative Site
Seoul, South Korea, 03080
Actively Recruiting
59
Novartis Investigative Site
Seoul, South Korea, 06351
Actively Recruiting
60
Novartis Investigative Site
Santander, Cantabria, Spain, 39008
Actively Recruiting
61
Novartis Investigative Site
Badajoz, Extremadura, Spain, 06080
Actively Recruiting
62
Novartis Investigative Site
Lugo, Galicia, Spain, 27003
Actively Recruiting
63
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Actively Recruiting
64
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
65
Novartis Investigative Site
Córdoba, Spain, 14004
Actively Recruiting
66
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
67
Novartis Investigative Site
Tainan, Taiwan, 704302
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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