Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
The study for each participant consists of a Screening period (28 days), a treatment period, a post-treatment safety follow-up (30 days) followed by a long-term follow-up period.
Eligible participants will be randomly allocated to one of three treatment arms. All treatments will be given orally, daily.
Arms 1 and 2 are both testing the combination of hormone therapies JSB462 and abiraterone. To determine the optimal dose of JSB462, Arm 1 will receive a lower dose (100 mg), while Arm 2 will receive a higher dose (300 mg).
In Arm 3, participants will receive either abiraterone or enzalutamide alone.
During the post-treatment follow-up period:
- Safety follow-up: After ending study treatment, all participants will be followed for at least 1 safety follow-up visit approximately 30 days after treatment ends. Further lines of treatment may be given according to Investigator's discretion after treatment discontinuation.
- Long-term follow up: Starts after the Safety follow-up period and lasts until the end of the study. Safety, efficacy and survival information may be collected form participants during this period.
Conditions
This trial is treating people with metastatic hormone sensitive prostate cancer (mHSPC)
Eligibility
Inclusion
- 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 outside the vertebral column and/or pelvis) in imaging exams (CT/MRI or bone scan) according to local radiology assessment by the investigator obtained ≤28 days prior to randomization
- 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 and/or ongoing GnRH analog/antagonist) for ≤90 days is allowed prior to randomization, provided that PSA zero (PSA level <0.2 ng/ml according to local laboratory as assessed by the investigator) is not achieved prior to randomization.
Exclusion
- Prior exposure to a second generation ARPI (such as enzalutamide/darolutamide/apalutamide and/or abiraterone) for the treatment of advanced/metastatic disease is not allowed. Prior exposure to ARPI, to taxane chemotherapy (up to 6 cycles) or to RLT in the context of (neo)adjuvant treatment for localized prostate cancer is allowed, if the last dose of this treatment was administered >12 months from randomization. Prior use of a first generation ARPI (such as bicalutamide) in the context of ADT initiation with a GnRH analog is allowed, provided the first generation ARPI was administered for ≤14 days and last dose was administered ≥7 days from randomization.
- Participants with biochemical recurrence only or those without evidence of metastatic disease by radiological imaging (CT/MRI or bone scan) are not eligible
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
Trial sponsor
Novartis Pharmaceuticals
Scientific 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)
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