NCT07163910 Homoharringtonine Plus Androgen Deprivation Therapy in the Neoadjuvant Treatment of Prostate Cancer: A Single-Arm Clinical Study
| NCT ID | NCT07163910 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | baotai Liang |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 93 participants |
| Start Date | 2025-04-20 |
| Primary Completion | 2027-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 93 participants in total. It began in 2025-04-20 with a primary completion date of 2027-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 effective treatment for patients with advanced prostate cancer.
Eligibility Criteria
Inclusion Criteria： ① Aged ≥ 18 years and ≤ 85 years; * Histologically or cytologically confirmed prostate cancer; * Patients meeting any of the following disease staging criteria: 1. 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); 2. Prostate cancer with local lymph node metastasis: presence of local lymph node metastasis (N1) but no distant metastasis (M0); 3. 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. Exclusion Criteria： 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.
Contact & Investigator
Chief Physician
STUDY DIRECTOR
Vice President of Zhongda Hospital Affiliated to Southeast University
Frequently Asked Questions
Who can join the NCT07163910 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 85 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07163910 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07163910 currently recruiting?
Yes, NCT07163910 is actively recruiting participants. Contact the research team at 2978793353@qq.com for enrollment information.
Where is the NCT07163910 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07163910 clinical trial?
NCT07163910 is sponsored by baotai Liang. The principal investigator is Chief Physician at Vice President of Zhongda Hospital Affiliated to Southeast University. The trial plans to enroll 93 participants.
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