RightFit
RecruitingPhase 3

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests pasritamig plus docetaxel compared with docetaxel alone. It is for people with prostate cancer that has spread and keeps growing despite low male hormone levels. Researchers want to see if the combination gives people more time before scans show the cancer getting worse or they die.

The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans or death due to any cause) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue test.
  • Have cancer that has spread, as shown by CT or MRI scans and a bone scan.
  • Keep taking hormone-lowering treatment called a GnRH analog during the study, or have had both testicles removed. Testosterone must be 50 ng/dL or lower at screening.
  • Have cancer that got worse on at least 1 but no more than 2 different newer hormone-blocking drugs called ARPIs, based on PSA blood tests or scans. Stop these drugs before being assigned to a study group.
  • Be fully active or able to do light work, even if hard physical activity is limited.

Who can't join

  • Have a known history of prostate cancer spreading to the brain or the tissue covering the brain and spinal cord.
  • Have a known BRCA1 or BRCA2 gene change but have not taken a PARP inhibitor, a type of cancer drug, unless it was unavailable or unsafe for you.
  • Have or have had another cancer besides the prostate cancer being studied.
  • Have received cell-killing chemotherapy for prostate cancer at any stage.
  • Have received treatment aimed at a protein called KLK-2.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: * Have histologically confirmed adenocarcinoma of the prostate * Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m\^Tc bone scan as determined by the investigator * Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (\<=) 50 nanogram per deciliter (ng/dL) (\<= 1.73 nanomoles per Liter \[nmol/L\]) at screening * Have progressed by PSA or CT/MRI or 99m\^Tc bone scan on at least 1 novel androgen receptor pathway inhibition (ARPI) but no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 Exclusion criteria: * Known history of either brain or leptomeningeal prostate cancer metastases * Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated * Prior or concurrent second malignancy (other than the disease under study) * Received cytotoxic chemotherapy for prostate cancer in any setting * Received prior treatment with human kallikrein 2 (KLK-2) directed therapies

Study sites (59)

AR

AZ

CA

CO

FL

GA

IL

KS

KY

LA

MA

MD

MI

MN

MO

MS

NC

NE

NJ

NY

OH

OR

PA

SC

SD

TN

TX

VA

WA