Clinical Study of Geranium Wilfordii Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer

baotai Liang

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Prostate CA

Treatments: Drug: Androgen deprivation treatment; Drug: Geranium wilfordii combined with androgen deprivation treatment; Procedure: radical prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06861166

2024ZDSYLL512-Y01

Details and patient eligibility

About

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 efficacy of geranium combined with androgen deprivation in the treatment of locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through randomized controlled clinical trials, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.

Full description

This study will divide patients into two sections, and eligible patients will be enrolled. Patients with locally advanced prostate cancer or oligo-metastatic prostate cancer were divided into geranium combined androgen deprivation therapy group and androgen deprivation therapy group according to a computer-generated random sequence. In the treatment group, except for continuous androgen deprivation treatment, geranium geranium decoction was taken orally every day; The control group only received continuous androgen deprivation therapy, and the usage was the same as the treatment group. After starting the intervention, all patients should be followed up in our hospital 7, 14, 28, 56, 84 days after treatment to review blood PSA and other indicators. At the end of the treatment, imaging examinations were followed up and radical prostatectomy was performed 3 weeks later (±7 days).

Enrollment: 95 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Geranium wilfordii combined with androgen deprivation treatment group

Experimental group

Description:

Geranium wilfordii 15g decoction (Geranium 15g, decocted by the decocting machine in the decocting room of the pharmacy Department of the hospital) was taken orally, 200mL/ time, once/day, for 3 months + continuous androgen deprivation treatment.After completion of treatment, radical prostatectomy was performed 3 weeks later (±7 days).

Treatment:

Procedure: radical prostatectomy

Drug: Androgen deprivation treatment

Androgen deprivation treatment group

Sham Comparator group

Description:

Continuous androgen deprivation therapy.After completion of treatment, radical prostatectomy was performed 3 weeks later (±7 days).

Treatment:

Procedure: radical prostatectomy

Drug: Geranium wilfordii combined with androgen deprivation treatment