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Looking for participantsPhase3

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT07225946

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pasritamig (drug), Docetaxel (drug), Prednisone/Prednisolone (drug)
How long the study runs
Study runs about 54 months (dates as stated)
About the drug or intervention
Pasritamig — drug: Pasritamig will be administered. · Docetaxel — drug: Docetaxel will be administered. · Prednisone/Prednisolone — drug: Prednisone/Prednisolone will be administered.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
800
Started
2025-12-19
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for prostatic neoplasms, castration-resistant
  • • Phase3 - 800 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostatic neoplasms, castration-resistant

Where?

  • • Cardiff - Velindre Cancer Centre
  • • Glasgow - Beatson West Of Scotland Cancer Centre
  • • London - St Bartholomews Hospital
  • • London - The Royal Marsden NHS Trust
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Prostatic Neoplasms, Castration-Resistant

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

PSA

Treatment history

Treatments you must have had:

  • ✓ discontinued ARPI

What the study is looking for

  • ✓Have confirmed by a biopsy adenocarcinoma of the prostate
  • ✓Have disease that is that has spread at the time of screening by computed tomography (CT) or magnetic resonance imaging...
  • ✓Have an activity scale (ECOG) performance status of 0 to 1

Who cannot take part

  • ✗Known history of either brain or leptomeningeal prostate cancer metastases
  • ✗Prior or concurrent second cancer (other than the disease under study)
  • ✗Received cytotoxic drug treatment for prostate cancer in any setting
  • ✗Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
See the full 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

Where Is This Study? (7 UK sites)

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

Beatson West Of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

St Bartholomews Hospital

London EC1A 7BE, United Kingdom

Recruiting

The Royal Marsden NHS Trust

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

Preston PR2 9HT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Paul Brown

Research.Access@lthtr.nhs.uk01772 522031

Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09