Prostate CancerEarly Phase 1NCT07516704
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
A Early Phase 1 study testing Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy in people with Prostate Cancer, run by Zhongda Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 12 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
- Conditions
- Prostate Cancer
- Being tested
- Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation TherapyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after surgery
PSA response rate
Measured: 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
Measured: 1 month after surgery
Secondary outcomes (5)
Pathological response after radical prostatectomy
Pathological response after radical prostatectomy (including positive surgical margins, tumor size, extraprostatic extension, seminal vesicle invasion, and lymph node involvement)
Measured: 1 month after surgery
TNM stage
Changes in TNM staging on imaging after neoadjuvant therapy and before surgery
Measured: 1 month after surgery
Other PFS
Other Progression-Free Survival (progression includes radiographic progression, castration resistance, need for further therapeutic intervention, etc.)
Measured: 1 month after surgery
Safety indicator: CTCAE 5.0 adverse event grading
Measured: 1 month after surgery
Quality of life score: EORTC QLQ-C30 questionnaire
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Xu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516704
- Sponsor's protocol ID
- 2026ZDSYLL031-P01
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07516704
- Acronym / sponsor ID
- 2026ZDSYLL031-P01
- Conditions
- Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ① Age ≥ 18 years and ≤ 85 years;
Key exclusion criteria (3 listed)
- ① Any prior or ongoing treatment for prostate cancer, including radiotherapy, chemotherapy, ADT, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation TherapyDocetaxel: 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 | Drug | Treatment group |
Primary outcome
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
5 secondary outcomes
Pathological response after radical prostatectomy
Time frame: 1 month after surgery
TNM stage
Time frame: 1 month after surgery
Other PFS
Time frame: 1 month after surgery
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy in people with Prostate Cancer, run by Zhongda Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Xu (86+025-83272000, njxbseu@seu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR or MRD Rate (time frame: 1 month after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.