Phase 3 Prostate Cancer Trial, Recruiting NCT05983783 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT05983783
Recruiting Phase 3

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:

  • Men between 40 and 80 years of age
  • People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed through a tissue or cell sample
  • People whose prostate cancer has spread to other parts of the body (metastatic disease)
  • People whose doctors consider them suitable to receive hormone-blocking therapy (ADT) and the chemotherapy drug Docetaxel
  • People who have either not yet started hormone-blocking therapy (ADT), or who started it no more than 12 weeks before joining the trial
  • People with a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
  • People whose blood test results meet specific requirements for blood cell counts, kidney function, liver function, and blood clotting (confirm exact values with the trial site)
  • People whose cancer has spread widely, defined as either: four or more bone metastases shown on a bone scan (with at least one outside the pelvis or spine), or cancer that has spread to internal organs (not counting lymph nodes), as seen on a CT or MRI scan

Who may not be able to join:

  • People who have previously received certain hormone therapies, advanced anti-androgen medications (such as enzalutamide, darolutamide, or similar drugs), enzyme-blocking treatments (such as abiraterone acetate or oral ketoconazole), or any chemotherapy or immunotherapy for prostate cancer
  • People who have had radiation therapy or radiopharmaceutical treatment within the 2 weeks before joining the trial
  • People who have experienced a stroke, heart attack, severe chest pain, heart bypass surgery, or significant heart failure within the 6 months before joining the trial
  • People who have had another cancer in the past, unless it was a certain type of treated skin cancer, a very early-stage bladder cancer, or any other cancer that has been fully in remission for at least 5 years (confirm with trial site)
  • People who have stomach or bowel conditions or have had procedures that may significantly affect how the body absorbs the trial medication
  • People who are unable to swallow or take medication by mouth

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 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: Lixxin Hua, Urology Dpt, First Affiliated Hospital of Nanjing Medical University

Phone: +862568303186

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
1 August 2023
Est. completion
31 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

rPFS

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