A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Conditions
- Metastatic Castration-resistant Prostate Neoplasms
- Interventions
- Biological: PasritamigOther: PlaceboDrug: Best Supportive Care (BSC)
- Registration Number
- NCT07164443
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in combination with best supportive care (BSC) as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 663
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pasritamig Plus Best Supportive Care (BSC) Pasritamig Participants will receive the step-up doses of pasritamig intravenously (IV) on Cycle 1 Day 1 (C1D1) and C1D8, and target dose of pasritamig IV on C1D15 (Cycle 1 duration is 8 weeks). From C2D1 onwards ( Cycle Duration is 6 week), participants will receive pasritamig target dose IV every 6 weeks. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician. Pasritamig Plus Best Supportive Care (BSC) Best Supportive Care (BSC) Participants will receive the step-up doses of pasritamig intravenously (IV) on Cycle 1 Day 1 (C1D1) and C1D8, and target dose of pasritamig IV on C1D15 (Cycle 1 duration is 8 weeks). From C2D1 onwards ( Cycle Duration is 6 week), participants will receive pasritamig target dose IV every 6 weeks. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician. Placebo Plus BSC Placebo Participants will receive the step-up doses of placebo IV on C1D1 and C1D8, and target dose of placebo on C1D15. From C2D1 onwards, participants will receive placebo target dose IV every 6 weeks and will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC at the discretion of the physician. Placebo Plus BSC Best Supportive Care (BSC) Participants will receive the step-up doses of placebo IV on C1D1 and C1D8, and target dose of placebo on C1D15. From C2D1 onwards, participants will receive placebo target dose IV every 6 weeks and will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC at the discretion of the physician.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 2 years and 8 months OS is defined as the time from randomization to date of death due to any cause.
- Secondary Outcome Measures
Name Time Method Radiographic Progression-free Survival (rPFS) Up to 2 years and 8 months rPFS assessed by investigator defined as the time from the date of randomization until the date of radiographic disease progression (based on response evaluation criteria in solid tumors \[RECIST\] v1.1 and prostate cancer working group 3 \[PCWG3\] criteria) or death, whichever comes first.
Time to Symptomatic Progression Up to 2 years and 8 months Time to symptomatic progression is defined as time from the date of randomization to the date of any of the following (whichever occurs first): (a) the use of external beam radiation therapy to relieve cancer-related symptoms; (b) the need for tumor-related orthopedic surgical intervention; (c) other cancer-related procedures; (d) cancer-related morbid events; (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
Time to Skeletal-Related Event Up to 2 years and 8 months Time to skeletal-related event is defined as the time from the date of randomization to the date of first occurrence of any of the following (whichever occurs first): (a) the use of external beam radiation for skeletal or pelvic symptoms; b) the need for tumor-related orthopedic surgical intervention; (c) the occurrence of new bone fractures (cancer-related); (d) the occurrence of tumor-related spinal cord compression.
Progression-Free Survival (PFS) Up to 2 years and 8 months PFS is defined as the date of randomization to the date of first evidence of radiographic progression, clinical progression, or death from any cause, whichever occurs first.
Time to Prostate Specific Antigen (PSA) Progression Up to 2 years and 8 months Time to PSA progression, defined as the time from randomization to the first date of documented PSA progression per PCWG3 criteria. PSA progression is defined as: after a decline from baseline, PSA increases \>= 25 percentage (%) and \>= 2 nanograms per milliliter (ng/mL) above the nadir, confirmed by a second value \>= 3 weeks later (that is, a confirmed rising trend), or If there is no decline from baseline, PSA increases \>= 25 % and \>= 2 ng/mL from baseline after 12 weeks.
Number of Participants with Adverse Events (AEs) Up to 2 years and 8 months An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time to Pain Progression (TTPP) as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) Item 3 Worst Pain in 24 Hours Up to 2 years and 8 months TTPP is defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression is defined as an increase of at least 2 points from baseline in the BPI-SF worst pain intensity (item 3) observed at 2 consecutive evaluations \>= 3 weeks apart. BPI-SF is an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score range from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine".
Time to Deterioration in Fatigue as Assessed by the European Organisation For Research And Treatment of Cancer Quality of Life Questionnaire-Core-30 (EORTC QLQ-C30) Fatigue Scale Score Up to 2 years and 8 months Time to deterioration is defined as the time from randomization to the date of the first observation of deterioration in Fatigue. Deterioration in Fatigue is defined as an increase of 10 points on the EORTC QLQ-C30 FA scale observed at 2 consecutive evaluations \>= 3 weeks apart. The EORTC QLQ-C30 is a widely used tool for assessing the quality of life of cancer patients in clinical trials. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent". Each subscale of the EORTC QLQ-C30 is scored on a range from 0 to 100. Higher scores indicate worse symptoms or problems.
Number of Participants with Abnormalities in Clinical Laboratory Assessments Up to 2 years and 8 months Participants with abnormalities in clinical laboratory parameters (hematology, clinical chemistry etc.) will be assessed.
Trial Locations
- Locations (12)
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Warringal Private Hospital
🇦🇺Heidelberg, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
Puerto Rico Medical Research Center
🇵🇷Hato Rey, Puerto Rico
Colorado Clinical Research
🇺🇸Lakewood, Colorado, United States
XCancer Omaha / Urology Cancer Center
🇺🇸Omaha, Nebraska, United States
Oregon Urology Institute
🇺🇸Springfield, Oregon, United States
MidLantic Urology
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Keystone Urology Specialists
🇺🇸Lancaster, Pennsylvania, United States
Scroll for more (2 remaining)Carolina Urologic Research Center🇺🇸Myrtle Beach, South Carolina, United States