NCT07516704Not yet recruitingEarly phase 1
Safety and Efficacy of Docetaxel, Darolutamide, and Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of High-Risk Prostate Cancer: A Multicenter Prospective, Single-Arm Clinical Study
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
Previous study findings suggest that the efficacy limitations of the neoadjuvant treatment regimen combining docetaxel with androgen deprivation therapy are associated with protein synthesis. Homoharringtonine (HHT) is currently the only small-molecule translation elongation inhibitor approved by the U.S. Food and Drug Administration (FDA). Building on this foundation, we plan to conduct a prospective interventional study aimed at validating whether the intensified quadruple regimen, formed by adding darolutamide and homoharringtonine (HHT) to the standard regimen, can further significantly enhance the depth of pathological response and improve patient outcomes through multi-mechanism synergy.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- First submitted
- 25 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Zhongda Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT07516704
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 94
- From 1 Apr 2026 to the primary completion date, 1 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ① Any prior or ongoing treatment for prostate cancer, including radiotherapy, chemotherapy, ADT, etc.;
- Previous prostatectomy; ③ Any other serious underlying medical, psychiatric, or psychological conditions that, in the investigator's judgment, may affect treatment;
- Allergy to any of the study drugs; ⑤ Refusal to undergo radical prostatectomy; ⑥ Deemed unsuitable for participation in this clinical trial by the investigator's judgment.
Who the study is looking for
- ① Age ≥ 18 years and ≤ 85 years;
- Histologically or cytologically confirmed prostate cancer;
- High-risk prostate cancer: meeting at least one of the following criteria: clinical stage T3-T4, or Gleason score 8-10, or PSA \> 20 ng/mL, or presence of distant metastasis (clinical stage M1); ④ ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1; ⑤ All patients voluntarily sign informed consent and are able to adhere to treatment and follow-up
Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.