NCT06834321 Clinical Study on Neoadjuvant Therapy of Homoharringtonine Combined With Androgen Deprivation for Prostate Cancer
| NCT ID | NCT06834321 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | baotai Liang |
| Condition | Prostate CA |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-03-19 |
| Primary Completion | 2026-09-28 |
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 96 participants in total. It began in 2025-03-19 with a primary completion date of 2026-09-28.
⚠ 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 high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD). The purpose of this project is to verify the therapeutic effect of homoharringtonine combined androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through a randomized controlled clinical trial, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.
Eligibility Criteria
Inclusion Criteria: * ① Age ≥18 years and ≤85 years; * Histologically confirmed prostate cancer without small cell features; * Metastatic prostate cancer was identified by imaging examination with ≤5 oligometastases (bone or lymph node metastases) or cT3-4 stages; ④The score of ECOG (Eastern Cooperative Oncology Group) was 0-1; ⑤ All patients voluntarily sign informed consent, and can adhere to treatment and follow-up; Exclusion Criteria: * ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc. * Previous prostatectomy; * Any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient * Allergic to the drugs used; ⑤ Refuse to undergo radical prostatectomy; ⑥ According to the investigator's judgment, it is not suitable to participate in this clinical trial;
Contact & Investigator
Vice President of Zhongda Hospital
STUDY DIRECTOR
Zhongda Hospital
Frequently Asked Questions
Who can join the NCT06834321 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 85 Years, studying Prostate CA. 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 NCT06834321 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 NCT06834321 currently recruiting?
Yes, NCT06834321 is actively recruiting participants. Contact the research team at 2978793353@qq.com for enrollment information.
Where is the NCT06834321 trial being conducted?
This trial is being conducted at Nanjing, China, Nantong, China.
Who is sponsoring the NCT06834321 clinical trial?
NCT06834321 is sponsored by baotai Liang. The principal investigator is Vice President of Zhongda Hospital at Zhongda Hospital. The trial plans to enroll 96 participants.