Trial comparing treatments for Metastatic Castration-resistant Prostatic Neoplasms
Official title A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
ClinicalTrials.gov ID: NCT07164443
What this study is testing
What is Pasritamig?
Pasritamig is an investigational biological medicine being studied as a potential treatment for metastatic castration‑resistant prostate cancer.
Also referred to as JNJ-78278343.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether pasritamig, with or without JNJ‑87189401, can extend overall survival compared with placebo.
- Who it's for
- Men who have metastatic prostate cancer that no longer responds to hormone therapy.
- What's involved
- Participants will receive either pasritamig plus standard supportive care, pasritamig with JNJ‑87189401 plus supportive care, or placebo with supportive care, and will undergo regular clinic visits and tests to monitor health.
- Time commitment
- Participants will be followed for the rest of their lives or until the study ends, with periodic visits and assessments throughout.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Histologically confirmed adenocarcinoma of the prostate
- Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of...
- PSA greater than or equal to (≥) 2 nanogram per milliliter (ng/mL) at screening
- In the opinion of the investigator, the next best treatment option is a clinical trial
- Cabazitaxel is not available
You likely can't join if
- Venous thromboembolic events within 1 month prior to the first dose of study treatment
- Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate...
- Participants with Grade 1 or higher fever (≥38ºC) or active infection requiring systemic treatment within 7 days prior to randomization are...
- Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (\>2 liters per minute (L/min) by nasal cannula)...
- Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any...
- Any of the following within 6 months prior to first dose of study treatment: A) Myocardial infarction B) Severe or unstable angina C) Clinically...
See the full eligibility criteria
- Histologically confirmed adenocarcinoma of the prostate
- Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional...
- PSA greater than or equal to (≥) 2 nanogram per milliliter (ng/mL) at screening
- In the opinion of the investigator, the next best treatment option is a clinical trial
- Cabazitaxel is not available
- PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.
- The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy.
- Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog [agonist or antagonist]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Participants are eligible if they have the following values: A) eGFR ≥ 40 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (≤) 3 times the...
- Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤ 2) deep vein thrombosis is not exclusionary
- Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)
- Participants with Grade 1 or higher fever (≥38ºC) or active infection requiring systemic treatment within 7 days prior to randomization are ineligible.
- Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (\>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation
- Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the how well it works of the study...
- Any of the following within 6 months prior to first dose of study treatment: A) Myocardial infarction B) Severe or unstable angina C) Clinically significant ventricular arrhythmias D) Congestive heart failure (New York...
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Lakewood, Colorado, United States
- Hartford, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Bay Pines, Florida, United States
- Fort Myers, Florida, United States
- Tampa, Florida, United States
- Iowa City, Iowa, United States
- Waukee, Iowa, United States
- Metairie, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Brooklyn, New York, United States
- Mineola, New York, United States
+ 133 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Lakewood, Colorado, United States; Hartford, Connecticut, United States and 147 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.