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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
663
Pasritamig will be administrated through IV infusion.
Placebo will be administrated through IV infusion.
BSC will be administered at the discretion of the treating physician.
University of California at San Diego
La Jolla, California, United States
RECRUITINGRonald Reagan UCLA Medical Center
Los Angeles, California, United States
RECRUITINGRocky Mountain Cancer Centers
Aurora, Colorado, United States
RECRUITINGUniversity of Colorado Cancer Center
Aurora, Colorado, United States
Overall Survival (OS)
OS is defined as the time from randomization to date of death due to any cause.
Time frame: Up to 2 years and 8 months
Radiographic Progression-free Survival (rPFS)
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 frame: Up to 2 years and 8 months
Time to Symptomatic Progression
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 frame: Up to 2 years and 8 months
Time to Skeletal-Related Event
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.
Time frame: Up to 2 years and 8 months
Progression-Free Survival (PFS)
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 frame: Up to 2 years and 8 months
Time to Prostate Specific Antigen (PSA) Progression
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.
Time frame: Up to 2 years and 8 months
Time to Pain Progression (TTPP) as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) Item 3 Worst Pain in 24 Hours
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 frame: Up to 2 years and 8 months
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
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.
Time frame: Up to 2 years and 8 months
Number of Participants with Adverse Events (AEs)
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 frame: Up to 2 years and 8 months
Number of Participants with Abnormalities in Clinical Laboratory Assessments
Participants with abnormalities in clinical laboratory parameters (hematology, clinical chemistry etc.) will be assessed.
Time frame: Up to 2 years and 8 months
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Colorado Clinical Research
Lakewood, Colorado, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
RECRUITINGJohns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
RECRUITINGBay Pines VA Healthcare System
Bay Pines, Florida, United States
RECRUITINGFlorida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITING...and 153 more locations