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Not yet recruiting NCT07516704

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

Early Phase I Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 18 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy
    \*\*Docetaxel:\*\* 75 mg/m², intravenous infusion, once every 3 weeks (administered in weeks 1, 4, and 7), for a total of 3 cycles. To prevent allergic reactions and fluid retention, oral dexamethasone 8 mg is administered twice daily on the day before, the day of, and the day after docetaxel infusion. \*\*Darolutamide:\*\* 600 mg, orally, twice daily, starting from day 1 of treatment and continued until 1 week before surgery. To be taken with food. \*\*Homoharringtonine:\*\* 1 mg of homoharr

Primary outcome measures

  • pCR or MRD Rate [Time frame: 1 month after surgery]
  • PSA response rate [Time frame: Defined as the comparison of PSA levels before neoadjuvant therapy and at the end of the neoadjuvant therapy cycle (before surgery).]
  • iochemical Progression-Free Survival (bPFS) after Radical Prostatectomy [Time frame: 1 month after surgery]
Secondary outcome measures (5)
  • Pathological response after radical prostatectomy [Time frame: 1 month after surgery]
  • TNM stage [Time frame: 1 month after surgery]
  • Other PFS [Time frame: 1 month after surgery]
  • Safety indicator: CTCAE 5.0 adverse event grading [Time frame: 1 month after surgery]
  • Quality of life score: EORTC QLQ-C30 questionnaire [Time frame: 1 month after surgery]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07516704 · 2026ZDSYLL031-P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗