Clinical trial · 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

NCT07516704CI-TRIAL-00107655not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Treatment group
interventionNames
1. Drug: Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy

Primary outcomes (3)

measure
pCR or MRD Rate
timeFrame
1 month after surgery
description
:-\*\*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.
measure
PSA response rate
timeFrame
Defined as the comparison of PSA levels before neoadjuvant therapy and at the end of the neoadjuvant therapy cycle (before surgery).

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years
Maximum age: 85 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.