Phase 3 Prostate Cancer Trial, Recruiting NCT07225946 Sponsor: Janssen Research & Development, LLC Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT07225946
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with prostate cancer (a specific type called adenocarcinoma), confirmed through a tissue sample test
  • People whose prostate cancer has spread to other parts of the body at the time of screening, as determined by the study doctor
  • People who are receiving ongoing hormone-blocking treatment (called androgen deprivation therapy) or who have had both testicles surgically removed, and whose testosterone levels in the blood are very low (at or below a specific threshold) at screening
  • People whose cancer has gotten worse after trying at least one — but no more than two — specific hormone-blocking drugs (called androgen receptor pathway inhibitors, or ARPIs), and who have stopped taking those drugs before joining the study
  • People who are generally well enough to carry out daily activities, rated as 0 or 1 on a standard medical fitness scale (confirm with trial site)

Who may not be able to join:

  • People whose prostate cancer has spread to the brain or to the lining around the brain or spinal cord
  • People who are known to carry BRCA1 or BRCA2 gene mutations (either inherited or developed) and have not yet been treated with a type of drug called a PARP inhibitor — unless that treatment was not available or was not suitable for them
  • People who have, or previously had, a second type of cancer (other than prostate cancer), where that cancer or its treatment could affect the results of this study
  • People who have received chemotherapy (cell-killing drugs) for prostate cancer at any point
  • People who have previously been treated with therapies that target a specific protein called human kallikrein 2 (KLK-2)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

Australian sites

Warringal Private Hospital, Heidelberg,
Icon Cancer Centre Kurralta Park, Kurralta Park,
Peter MacCallum Cancer Centre, Melbourne,
Sydney Adventist Hospital, Wahroonga,
Princess Alexandra Hospital, Woolloongabba,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
19 December 2025
Est. completion
19 November 2027

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia Puerto Rico 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Radiographic Progression-Free Survival (rPFS) Assessed by BICR

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov