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

NCT07516704 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 2026ZDSYLL031-P01
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• pCR or MRD Rate

  :-\*\*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.

  1 month after surgery

• PSA response rate

  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

  1 month after surgery

Secondary Outcomes (5)

• Pathological response after radical prostatectomy

  1 month after surgery

• TNM stage

  1 month after surgery

• Other PFS

  1 month after surgery

• Safety indicator: CTCAE 5.0 adverse event grading

  1 month after surgery

• Quality of life score: EORTC QLQ-C30 questionnaire

  1 month after surgery

Other Outcomes (5)

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

  1 month after surgery

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

  1 month after surgery

• Change in prespecified intratumoral microbiome features before and after neoadjuvant treatment

  1 month after surgery

Study Arms (1)

Treatment group

EXPERIMENTAL

Drug: Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy

Interventions

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

Treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Bin Xu

CONTACT

86+025-83272000; njxbseu@seu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Dean

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 12, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR