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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07164443
Registration number
NCT07164443
Ethics application status
Date submitted
4/09/2025
Date registered
10/09/2025
Date last updated
10/09/2025
Titles & IDs
Public title
A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
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Scientific title
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
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Secondary ID [1]
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78278343PCR3001
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Secondary ID [2]
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78278343PCR3001
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Universal Trial Number (UTN)
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Trial acronym
KLK2-comPAS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Neoplasms
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pasritamig
Other interventions - Placebo
Treatment: Drugs - Best Supportive Care (BSC)
Experimental: Pasritamig Plus Best Supportive Care (BSC) - 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.
Placebo comparator: Placebo Plus BSC - 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.
Treatment: Other: Pasritamig
Pasritamig will be administrated through IV infusion.
Other interventions: Placebo
Placebo will be administrated through IV infusion.
Treatment: Drugs: Best Supportive Care (BSC)
BSC will be administered as per physician.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Intervention code [3]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization to date of death due to any cause.
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Timepoint [1]
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Up to 4 years and 8 months
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Secondary outcome [1]
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Radiographic Progression-free Survival (rPFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 4 years and 8 months
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Secondary outcome [2]
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Time to Symptomatic Progression
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 4 years and 8 months
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Secondary outcome [3]
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Time to Skeletal-Related Event
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 4 years and 8 months
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Secondary outcome [4]
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Progression-Free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 4 years and 8 months
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Secondary outcome [5]
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Time to Prostate Specific Antigen (PSA) Progression
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 4 years and 8 months
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Secondary outcome [6]
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Time to Pain Progression (TTPP) as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) Item 3 Worst Pain in 24 Hours
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 4 years and 8 months
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Secondary outcome [7]
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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
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 4 years and 8 months
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Secondary outcome [8]
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Number of Participants with Adverse Events (AEs)
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Assessment method [8]
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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.
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Timepoint [8]
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Up to 4 years and 8 months
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Secondary outcome [9]
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Number of Participants with Abnormalities in Clinical Laboratory Assessments
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Assessment method [9]
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Participants with abnormalities in clinical laboratory parameters (hematology, clinical chemistry etc.) will be assessed.
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Timepoint [9]
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Up to 4 years and 8 months
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Eligibility
Key inclusion criteria
Inclusion 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 metastasis to visceral organs at the time of screening
* 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 setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following:
Androgen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI
Taxanes: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if:
1. Cabazitaxel is not available
2. 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 a single agent or in combination with other therapies) administered within the same 2-month period.
Radioligand therapy: Should have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies:
1. PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.
2. 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 with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available
* 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 (<=) 5 times the Upper Limit of Normal (ULN) C) Serum total bilirubin <= 3 * ULN D) Absolute neutrophil count (ANC) >= 1.0 *10^9/per liter (L) E) Hemoglobin >= 8.0 grams per deciliter (g/dL) F) Platelet count >= 75 * 109/L
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
* 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 quires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)
* 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 efficacy of the study treatment(s)
* 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 Heart Association class II to IV) E) Transient ischemic attack F) Cerebrovascular accident
- Prior treatment with any CD3-directed therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
30/09/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/05/2028
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Actual
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Sample size
Target
663
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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ICON Cancer Care - Kurralta Park
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Recruitment postcode(s) [1]
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5037 - Kurralta Park
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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United States of America
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State/province [2]
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Nebraska
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Country [3]
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United States of America
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State/province [3]
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Oregon
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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Puerto Rico
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State/province [5]
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Rio Piedras
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT07164443
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Country
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07164443
Download to PDF