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

ConditionProstate Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • homoharringtonine

    Drug

    Intravenous infusion of 1mg homoharringtonine plus 250ml of 5% glucose injection, administered once daily for two consecutive days.

  • Radical prostatectomy

    Procedure/Surgery

    All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment.

Treatment groups

93 Participants
are divided into 2 treatment groups
Group A: Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate CancerExperimental treatment 2 interventions
Group B: Patients with metastatic prostate cancerExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

pCR or MRD rate

Time frame
Within three weeks after the operation
2

PSA response rate

Time frame
Within one week after the completion of the last treatment cycle (each treatment cycle lasts approximately 25 days)
3

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.

Secondary outcomes

1

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
2

Changes in radiological TNM staging from post-neoadjuvant therapy to pre-surgery

Time frame
Within one month after the surgery
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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