Phase 2 Prostate Cancer Trial, Recruiting NCT06029036 Sponsor: Peking University First Hospital Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06029036
Recruiting Phase 2

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:

  • You are male and at least 18 years old
  • You are able to sign a consent form on your own, without assistance
  • You have been diagnosed with prostate cancer (specifically adenocarcinoma) that has not spread to distant parts of the body
  • Your cancer is considered "high-risk," meaning your Gleason score is 8 or higher, your PSA level is above 20 ng/ml, or your tumor is at least clinical stage T3a (confirm with trial site if unsure which category applies to you)
  • You have cancer that has spread to nearby pelvic lymph nodes (this does not automatically disqualify you)
  • Your doctor considers you a suitable candidate for surgery to remove the prostate, with or without removal of nearby lymph nodes
  • You are generally active and able to carry out daily activities with little to no limitations (performance score of 0 or 1)
  • Your blood counts, kidney function, and liver function meet certain minimum health levels as measured by blood tests (confirm specific values with trial site)

Who may not be able to join:

  • Your prostate cancer has a rare cell type, such as neuroendocrine or small cell features
  • Your cancer has spread to distant parts of the body, such as bones or organs
  • You have previously received any treatment for prostate cancer, including radiation or hormone therapy
  • You are planning to have both testicles surgically removed during the study period
  • You are unable to tolerate the study drugs (darolutamide or hormone therapy)
  • You are currently participating in another clinical trial
  • You have been diagnosed with another cancer within the last 5 years
  • You have serious heart disease, an active infection, significant digestive system problems, or other major health complications (confirm with trial site)
  • Your doctor believes any other health condition would make participation unsafe or unsuitable for you

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 23 July 2026
Phase 2: approximately ~30% 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

Phone: +8610-83572418

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 2
Sponsor
Peking University First Hospital
Registry
ClinicalTrials.gov
Start date
5 August 2023
Est. completion
31 July 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Rate of pathological downstaging

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: 23 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