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).

A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Metastatic Castration-resistant Prostate Neoplasms

Metastatic Castration-resistant Prostate Cancer

Metastatic Prostate Cancer

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Genitourinary Cancer

Prostate Neoplasms

Advanced Solid Tumors

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

Placebo

Pasritamig

Best Supportive Care (BSC)

A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer

OS is defined as the time from randomization to date of death due to any cause.

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 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 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.

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 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.

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 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.

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.

Participants with abnormalities in clinical laboratory parameters (hematology, clinical
chemistry etc.) will be assessed.

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.

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.

Colorado Clinical Research

XCancer Omaha / Urology Cancer Center

Oregon Urology Institute

MidLantic Urology

Keystone Urology Specialists

ICON Cancer Care

Pan American Center for Oncology Trials LLC

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 (for
example, a confirmed rising trend), or If there is no decline from baseline, PSA
increases >= 25 % and >= 2 ng/mL from baseline after 12 weeks.

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 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.

Participants will receive the step-up doses of placebo IV on C1D1, 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.

A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Trials at a glance

Trials at a glance

A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Outcome measures

Primary outcome measures

Secondary outcome measures