Health TrialsbyHealthPanel

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

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

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Homoharringtonine combined with androgen deprivation therapy

    Drug

    Homoharringtonine 1mg intravenous infusion +5% glucose injection 250ml intravenous infusion, once a day for two consecutive days, repeated administration after three weeks of intermittent treatment, lasting two cycles + continuous androgen deprivation therapy.

  • Placebo combined with androgen deprivation treatment group

    Drug

    Placebo 1mg intravenous infusion +5% glucose injection 250ml intravenous infusion, once a day for two consecutive days, and repeated administration after a break of three weeks for two cycles + continuous androgen deprivation therapy,placebo is 5% glucose injection.

  • radical prostatectomy

    Procedure/Surgery

    Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Homoharringtonine combined with androgen deprivation treatment groupExperimental treatment 2 interventions
Group B: Placebo combined with androgen deprivation treatment groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

pCR or MRD rate

pCR (pathological complete response) is defined as cancer that is not morphologically recognizable in a prostatectomy specimen; MRD (small residual lesion) was defined as the maximum cross-section size of the residual tumor ≤5 mm, and RCB (residual cancer load) ≤ 0.25cm3 (tumor volume ≤ 0.5cm3 × tumor cells ≤ 50%) was used to calculate the tumor volume through three-dimensional volume estimation according to the maximum cross-section size and number of cross-sections involved in the tumor. Correction of tumor cell structure;

Time frame
up to 4 weeks

Secondary outcomes

1

PSA level change

Time frame
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
2

Biochemical progression-free survival after radical prostatectomy

Time frame
The evaluation period was up to 1 year from the date of completion of surgery to the date of first recorded psa progression
3

Pathologic responses after radical prostatectomy (including positive surgical margin, tumor size, prostatic extension, seminal vesicle infiltration, and lymph node involvement)

Time frame
up to 4 weeks

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 First People Hospital of Nantong City

Collaborator

Source ClinicalTrials.gov
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