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Compares treatment options for Metastatic Castration-resistant Prostate Neoplasms
Official title A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
ClinicalTrials.gov ID: NCT07164443
What this study is testing
What is Pasritamig?
Pasritamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic castration-resistant prostate neoplasms.
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 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).
- 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
- Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which...
You likely can't join if
- Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade \<= 2) deep vein thrombosis is not...
- 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
- Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease...
- Cabazitaxel is not available
- The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as...
- 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. Polyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Should have been previously treated...
- 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 \>= 30 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (\ = 1.0x10\^9/per...
- 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. Participants must be afebrile (\<38ºC) at the time of study...
- 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's taking place
- La Jolla, California, United States
- Los Angeles, 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
- Omaha, Nebraska, 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 - 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?
Study sites include La Jolla, California, United States; Los Angeles, California, United States; Aurora, Colorado, United States; Lakewood, Colorado, United States; Hartford, Connecticut, United States; Washington D.C., District of Columbia, United States and 147 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.