Prostate Cancer Trial, Recruiting NCT06661122 Sponsor: Bayer Condition: Prostate Cancer
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Prostate Cancer Trial, Recruiting

NCT06661122
Recruiting Not Applicable

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 (specifically a type called adenocarcinoma), confirmed through a tissue or cell sample test.
  • People whose prostate cancer has spread to other parts of the body (metastatic), but only at a low level — meaning they do not have cancer spread to internal organs, and have fewer than four bone spots, or bone spots only within the spine or pelvis.
  • People who have been diagnosed with prostate cancer that has spread but still responds to hormone-reducing treatment (sometimes called hormone-sensitive prostate cancer).
  • People who have already been placed on a three-drug treatment plan by their doctor, regardless of whether they are enrolled in this study.
  • People who started hormone-suppressing treatment (ADT) either within six months before the study reference date or at that date.
  • People (or their legal representatives, if the patient has passed away) who have provided signed consent to participate — in some situations where signed consent is difficult to obtain, an opt-out consent process may be accepted in line with ethical guidelines.

Who may not be able to join:

  • People who received the chemotherapy drug docetaxel before starting the drug darolutamide.
  • People who are taking part in another research program that involves treatments outside of standard clinical care.
  • People for whom darolutamide, docetaxel, or hormone-suppressing treatment (ADT) are not medically suitable, based on locally approved prescribing rules.
  • People who are already participating in a specific related safety study of darolutamide for this type of prostate cancer (the DADOX study, trial number NCT06010914).

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 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: (+)1-888-84 22937

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
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
18 November 2024
Est. completion
31 March 2031

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Proportion of patients with absolute prostate-specific antigen (PSA) response at 12 months; Number of patients with adverse event of special interests (AESIs), serious adverse events (SAEs) and adverse events (AEs) leading to dose modification or discontinuation of darolutamide or docetaxel at 12 months

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: 19 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