Trial · 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
NCT07516704, Early phase 1, Not yet recruiting, Zhongda Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. 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. Trials, record NCT07516704. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07516704
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT07516704
- Status
- Not yet recruiting
- Phases
- Early phase 1
- Enrollment
- 94 participants, estimated
- Lead sponsor
- Zhongda Hospital
- Conditions
- Prostate Cancer
- Interventions
- Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy
- First posted
- 2026-04-08
- Last updated
- 2026-04-08
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | pCR or MRD Rate | 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. |
| Primary | PSA response rate | Defined as the comparison of PSA levels before neoadjuvant therapy and at the end of the neoadjuvant therapy cycle (before surgery). | |
| Primary | iochemical Progression-Free Survival (bPFS) after Radical Prostatectomy | 1 month after surgery | |
| Secondary | Pathological response after radical prostatectomy | 1 month after surgery | Pathological response after radical prostatectomy (including positive surgical margins, tumor size, extraprostatic extension, seminal vesicle invasion, and lymph node involvement) |
| Secondary | TNM stage | 1 month after surgery | Changes in TNM staging on imaging after neoadjuvant therapy and before surgery |
| Secondary | Other PFS | 1 month after surgery | Other Progression-Free Survival (progression includes radiographic progression, castration resistance, need for further therapeutic intervention, etc.) |
| Secondary | Safety indicator: CTCAE 5.0 adverse event grading | 1 month after surgery | |
| Secondary | Quality of life score: EORTC QLQ-C30 questionnaire | 1 month after surgery | |
| Other | Change in prespecified transcriptomic features in tumor tissue before and after neoadjuvant treatment | 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. |
| Other | Change in prespecified proteomic features in tumor tissue before and after neoadjuvant treatment | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07516704
GET https://conductscience.org/api/trials/v1/NCT07516704/registered