Phase 3 study for people with Prostate Cancer

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Janssen Research & Development, LLC
Registry number NCT07225946
Started 19 December 2025 Today 16 October 2026 Estimated completion 19 November 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Warringal Private Hospital Heidelberg VIC Recruiting
Icon Cancer Centre Kurralta Park Kurralta Park SA Recruiting
Peter MacCallum Cancer Centre Melbourne VIC Recruiting
Sydney Adventist Hospital Wahroonga NSW Recruiting
Princess Alexandra Hospital Woolloongabba QLD Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 800

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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

Dates on the record

Started 19 December 2025
Estimated completion 19 November 2027
Registry last updated 25 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 25 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.