Homoharringtonine Plus Androgen Deprivation Therapy in the Neoadjuvant Treatment of Prostate Cancer: A Single-Arm Clinical Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-85
Sponsorbaotai Liang

About this trial

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

Qualifiers

Histologically or cytologically confirmed prostate cancer;

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.

Disqualifiers

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 design

Treatments tested in this trial

  • homoharringtonine
  • Radical prostatectomy

Treatment groups

93 Participants
are divided into 2 treatment groups

Sponsors and collaborators

baotai Liang

Lead sponsor

Zhongda Hospital

Sponsor institution

The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Collaborator

Subei People's Hospital of Jiangsu Province

Collaborator

The First People Hospital of Nantong City

Collaborator