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NCT Number: 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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy

Drug

**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 homoharringtonine diluted in 250 mL of 5% glucose injection, administered intravenously once daily for two consecutive days, repeated every 3 weeks (administered in weeks 1, 4, and 7), for a total of 3 cycles.

**Androgen Deprivation Therapy:** Luteinizing hormone-releasing hormone (LHRH) analogs such as goserelin. The specific dosage is goserelin 3.6 mg, administered as a subcutaneous injection into the anterior abdominal wall once every 28 day

Primary outcomes

  1. pCR or MRD Rate

    Time frame: 1 month after surgery

    :-**pCR (Pathological Complete Response)** is defined as the absence of morphologically identifiable cancer in the prostatectomy specimen.

    • **MRD (Minimal Residual Disease)** is defined as a maximum cross-sectional diameter of residual tumor ≤ 5 mm, and using RCB (Residual Cancer Burden) ≤ 0.25 cm³ (tumor volume ≤ 0.5 cm³ × tumor cellularity ≤ 50%). Tumor volume is calculated by three-dimensional volume estimation based on the largest cross-sectional dimension of the tumor and the number of cross-sections, with adjustment for tumor cellularity.

  2. 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).

  3. iochemical Progression-Free Survival (bPFS) after Radical Prostatectomy

    Time frame: 1 month after surgery

Secondary outcomes

  1. Pathological response after radical prostatectomy

    Time frame: 1 month after surgery

    Pathological response after radical prostatectomy (including positive surgical margins, tumor size, extraprostatic extension, seminal vesicle invasion, and lymph node involvement)

  2. TNM stage

    Time frame: 1 month after surgery

    Changes in TNM staging on imaging after neoadjuvant therapy and before surgery

  3. Other PFS

    Time frame: 1 month after surgery

    Other Progression-Free Survival (progression includes radiographic progression, castration resistance, need for further therapeutic intervention, etc.)

  4. Safety indicator: CTCAE 5.0 adverse event grading

    Time frame: 1 month after surgery

  5. Quality of life score: EORTC QLQ-C30 questionnaire

    Time frame: 1 month after surgery

Other outcomes

  1. Change in prespecified transcriptomic features in tumor tissue before and after neoadjuvant treatment

    Time frame: 1 month after surgery

    Change in prespecified transcriptomic features measured in paired tumor tissue samples collected before treatment and at radical prostatectomy, assessed using bulk RNA sequencing and/or single-cell or spatial transcriptomic profiling.

  2. Change in prespecified proteomic features in tumor tissue before and after neoadjuvant treatment

    Time frame: 1 month after surgery

    Change in prespecified proteomic features measured in paired tumor tissue samples collected before treatment and at radical prostatectomy, assessed using proteomic profiling.

  3. Change in prespecified intratumoral microbiome features before and after neoadjuvant treatment

    Time frame: 1 month after surgery

    Change in prespecified intratumoral microbiome features measured in paired tumor tissue samples collected before treatment and at radical prostatectomy, including microbial composition, relative abundance of prespecified taxa, and diversity indices.

  4. Difference in tumor tissue molecular features between participants who achieve and do not achieve the primary endpoint

    Time frame: 1 month after surgery

    Difference in prespecified transcriptomic and proteomic features in tumor tissue between participants who achieve the primary endpoint (pathological complete response or minimal residual disease) and those who do not, assessed using tissue obtained at radical prostatectomy.

  5. Change in prespecified liquid biopsy biomarkers before and after neoadjuvant treatment

    Time frame: 1 month after surgery

    Change in prespecified liquid biopsy biomarkers measured in blood and/or urine samples collected before treatment and after completion of neoadjuvant therapy, including genomic, proteomic, and metabolomic indicators associated with treatment response.

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Xu

CONTACT

[email protected]

86+025-83272000

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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