Prostate CancerPhase 2NCT07163910
Homoharringtonine Plus Androgen Deprivation Therapy in the Neoadjuvant Treatment of Prostate Cancer: A Single-Arm Clinical Study
A Phase 2 study testing homoharringtonine and Radical prostatectomy in people with Prostate Cancer, run by baotai Liang at 1 site in China.
Trial summary
The project aims to verify the therapeutic effect of neoadjuvant homoharringtonine combined with androgen deprivation therapy in patients with localized high-risk/very high-risk, regional lymph node-metastatic, or metastatic prostate cancer before radical prostatectomy through clinical trials, thereby identifying an… 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?
- homoharringtonine and Radical prostatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 20 Dec 2027
- Phase
- Phase 2
- 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 Aged ≥ 18 years and ≤ 85 years;
- Histologically or cytologically confirmed prostate cancer;
- Patients meeting any of the following disease staging criteria:
- Localized high-risk/very high-risk prostate cancer: meeting at least one of the following characteristics (clinical stage T3-T4, Gleason score ≥ 8, primary Gleason pattern 5, or PSA > 20 ng/mL), with no local lymph node metastasis (N0) and no distant metastasis (M0);
- Prostate cancer with local lymph node metastasis: presence of local lymph node metastasis (N1) but no distant metastasis (M0);
- Metastatic prostate cancer: confirmed as metastatic prostate cancer by imaging examinations; ④ Physical status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; ⑤ Informed consent: All patients voluntarily sign the informed consent form and can adhere to treatment and follow-up.
Who cannot join
- ① Any previous or ongoing prostate cancer treatment, including radiotherapy, chemotherapy, androgen deprivation therapy (ADT), etc.;
- A history of previous prostatectomy;
- Any other severe underlying medical, psychiatric, or psychological diseases that, in the investigator's judgment, may affect the treatment;
- A history of allergy to the drugs used in the study; ⑤ Refusal to undergo radical prostatectomy; ⑥ Ineligibility to participate in this clinical trial as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210009
baotai liang, 18852069821, 2978793353@qq.com
About this study
Official title: Clinical Study of Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of Prostate Cancer
The project aims to verify the therapeutic effect of neoadjuvant homoharringtonine combined with androgen deprivation therapy in patients with localized high-risk/very high-risk, regional lymph node-metastatic, or metastatic prostate cancer before radical prostatectomy through clinical trials, thereby identifying an effective treatment for patients with advanced prostate cancer.
Read the detailed description
This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, they will receive an intravenous infusion of homoharringtonine (1 mg) plus an intravenous infusion of 5% glucose injection (250 ml), once daily for two consecutive days. Patients with localized high-risk/very high-risk and regional lymph node-metastatic prostate cancer will receive at least one cycle of the above treatment plus continuous androgen deprivation therapy; patients with metastatic prostate cancer will receive one cycle of treatment, followed by a three-week interval before repeated medication, with the treatment repeated for a total of at least three cycles plus continuous androgen deprivation therapy. All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the end of treatment.
- Conditions
- Prostate Cancer
- Being tested
- homoharringtonine, Radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
homoharringtonineDrug
Also called drug therapy
Intravenous infusion of 1mg homoharringtonine plus 250ml of 5% glucose injection, administered once daily for two consecutive days.
Radical prostatectomyProcedure or surgery
Also called operative treatment
All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer | Experimental | This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, the treatment regimen will consist of intravenous infusion of 1mg homoharringtonine combined with 250ml of 5% glucose injection, administered once daily for two consecutive days. Patients with localized high-risk/very high-risk prostate cancer or prostate cancer with local lymph node metastasis will receive at least one cycle of the above treatment plus continuous androgen deprivation therapy.All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment. Receives: Drug: homoharringtonine; Procedure: Radical prostatectomy |
| Patients with metastatic prostate cancer | Experimental | This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, the treatment will consist of intravenous infusion of 1mg homoharringtonine plus 250ml of 5% glucose injection, administered once daily for two consecutive days. For patients with metastatic prostate cancer, the medication will be repeated after an interval of three weeks following one treatment cycle, with the entire course lasting for at least three cycles, in addition to continuous androgen deprivation therapy. All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment. Receives: Drug: homoharringtonine; Procedure: Radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR or MRD rate
Measured: Within three weeks after the operation
PSA response rate
Measured: Within one week after the completion of the last treatment cycle (each treatment cycle lasts approximately 25 days)
Biochemical Progression-Free Survival (bPFS) after radical prostatectomy
Measured: From the date of random grouping to the date when progression was first recorded or the date of any cause of death (whichever comes first), an assessment was conducted for a period of up to 5 years.
Secondary outcomes (5)
Pathological response after radical prostatectomy (including positive surgical margins, tumor size, extraprostatic extension, seminal vesicle invasion, and lymph node involvement)
Measured: Within one month after the surgery
Changes in radiological TNM staging from post-neoadjuvant therapy to pre-surgery
Measured: Within one month after the surgery
Other progression-free survival (progression includes radiological progression, castration resistance, need for further therapeutic intervention, etc.)
Measured: From the date of random grouping to the date when progression was first recorded or the date of any cause of death (whichever comes first), an assessment was conducted for a period of up to 5 years.
Safety indicator: CTCAE 5.0 Adverse Event Grading
Measured: From the date of random grouping to the date when progression was first recorded or the date of any cause of death, an assessment was conducted for a period of up to 5 years.
Quality of life score: EORTC QLQ-C30 scale
Measured: From the date of random grouping to the date when progression was first recorded or the date of any cause of death, an assessment was conducted for a period of up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start20 Apr 2025
- Primary completion20 Sep 2027 (estimated)
- Study completion20 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- baotai Liang
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Subei People's Hospital of Jiangsu Province, The First People Hospital of Nantong City
- Responsible party
- Sponsor-investigator, baotai Liang, Zhongda Hospital
- Investigators
- Chief Physician, Study director, Vice President of Zhongda Hospital Affiliated to Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163910
- Sponsor's protocol ID
- 2024ZDSYLL510-P02
- Status last verified
- Nov 2025
- First submitted
- 20 Aug 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of Prostate Cancer
- ClinicalTrials.gov ID
- NCT07163910
- Acronym / sponsor ID
- 2024ZDSYLL510-P02
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- baotai LiangUniversity, hospital or other
- Collaborators
- The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Subei People's Hospital of Jiangsu Province, The First People Hospital of Nantong City
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 9 Sep 2025 (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.
The project aims to verify the therapeutic effect of neoadjuvant homoharringtonine combined with androgen deprivation therapy in patients with localized high-risk/very high-risk, regional lymph node-metastatic, or metastatic prostate cancer before radical prostatectomy through clinical trials, thereby identifying an effective treatment for patients with advanced prostate cancer.
Detailed description
This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, they will receive an intravenous infusion of homoharringtonine (1 mg) plus an intravenous infusion of 5% glucose injection (250 ml), once daily for two consecutive days. Patients with localized high-risk/very high-risk and regional lymph node-metastatic prostate cancer will receive at least one cycle of the above treatment plus continuous androgen deprivation therapy; patients with metastatic prostate cancer will receive one cycle of treatment, followed by a three-week interval before repeated medication, with the treatment repeated for a total of at least three cycles plus continuous androgen deprivation therapy. All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer | Experimental | Drug: homoharringtonine, Procedure: Radical prostatectomyThis study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, the treatment regimen will consist of intravenous infusion of 1mg homoharringtonine combined with 250ml of 5% glucose injection, administered once daily for two consecutive days. Patients with localized high-risk/very high-risk prostate cancer or prostate cancer with local lymph node metastasis will receive at least one cycle of the above treatment plus continuous androgen deprivation therapy.All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment. |
| Patients with metastatic prostate cancer | Experimental | Drug: homoharringtonine, Procedure: Radical prostatectomyThis study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, the treatment will consist of intravenous infusion of 1mg homoharringtonine plus 250ml of 5% glucose injection, administered once daily for two consecutive days. For patients with metastatic prostate cancer, the medication will be repeated after an interval of three weeks following one treatment cycle, with the entire course lasting for at least three cycles, in addition to continuous androgen deprivation therapy. All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ① Aged ≥ 18 years and ≤ 85 years;
- Histologically or cytologically confirmed prostate cancer;
Key exclusion criteria (4 listed)
- ① Any previous or ongoing prostate cancer treatment, including radiotherapy, chemotherapy, androgen deprivation therapy (ADT), etc.;
- A history of previous prostatectomy;
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 |
|---|---|---|
| homoharringtonineAlso: drug therapyIntravenous infusion of 1mg homoharringtonine plus 250ml of 5% glucose injection, administered once daily for two consecutive days. | Drug | Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer, Patients with metastatic prostate cancer |
| Radical prostatectomyAlso: operative treatmentAll patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment. | Procedure or surgery | Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer, Patients with metastatic prostate cancer |
Primary outcome
pCR or MRD rate
Time frame: Within three weeks after the operation
PSA response rate
Time frame: Within one week after the completion of the last treatment cycle (each treatment cycle lasts approximately 25 days)
Biochemical Progression-Free Survival (bPFS) after radical prostatectomy
Time frame: From the date of random grouping to the date when progression was first recorded or the date of any cause of death (whichever comes first), an assessment was conducted for a period of up to 5 years.
5 secondary outcomes
Pathological response after radical prostatectomy (including positive surgical margins, tumor size, extraprostatic extension, seminal vesicle invasion, and lymph node involvement)
Time frame: Within one month after the surgery
Changes in radiological TNM staging from post-neoadjuvant therapy to pre-surgery
Time frame: Within one month after the surgery
Other progression-free survival (progression includes radiological progression, castration resistance, need for further therapeutic intervention, etc.)
Time frame: From the date of random grouping to the date when progression was first recorded or the date of any cause of death (whichever comes first), an assessment was conducted for a period of up to 5 years.
Safety indicator: CTCAE 5.0 Adverse Event Grading
Time frame: From the date of random grouping to the date when progression was first recorded or the date of any cause of death, an assessment was conducted for a period of up to 5 years.
Quality of life score: EORTC QLQ-C30 scale
Time frame: From the date of random grouping to the date when progression was first recorded or the date of any cause of death, an assessment was conducted for a period of up to 5 years.
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 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Chief Physician study director
Vice President of Zhongda Hospital Affiliated to Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing homoharringtonine and Radical prostatectomy in people with Prostate Cancer, run by baotai Liang at 1 site in China.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 resident doctor (中国+1885069821, 2978793353@qq.com), 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: Within three weeks after the operation). 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 18 Nov 2025.