Clinical Study on Neoadjuvant Therapy of Homoharringtonine Combined With Androgen Deprivation for Prostate Cancer

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Prostate CA

In brief

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.

Key facts

Study ID

NCT06834321

Run by

baotai Liang

People needed

96

Starts

2025-03-19

Expected to finish

2027-09-28

Last updated by the study team

2025-09-08

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• Zhongda Hospital — Nanjing, Jiangsu, China (enrolling)
• The First People Hospital of Nantong City — Nantong, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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