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NCT07516704·Early Phase 1·INTERVENTIONAL

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

GoserelinOtherNot yet recruiting

Status

Not yet recruiting

Phase

Early Phase 1

Enrollment

94

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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 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

Timeline

From registration to results.

  1. First posted

    Apr 8, 2026

  2. Study start

    Apr 1, 2026

  3. Primary completion

    Dec 1, 2027

  4. Study completion

    Dec 12, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Apr 8, 2026

Outcomes

What the study measures.

Primary outcomes

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.

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 outcomes

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)

TNM stage

Time frame · 1 month after surgery

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

Other PFS

Time frame · 1 month after surgery

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

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

Who can take part.

Minimum age
18 Years
Maximum age
85 Years
Sex
MALE
Healthy volunteers
No

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.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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