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

March 5, 2025 updated by: baotai Liang

Randomized Controlled Study of Geranium Wilfordii Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

95

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Geranium wilfordii combined with androgen deprivation treatment group
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).
Drug: Androgen deprivation treatment
Continuous androgen deprivation therapy
Procedure: radical prostatectomy
After completion of treatment, radical prostatectomy was performed 3 weeks later (±7 days).
Sham Comparator: Androgen deprivation treatment group
Continuous androgen deprivation therapy.After completion of treatment, radical prostatectomy was performed 3 weeks later (±7 days).
Procedure: radical prostatectomy
After completion of treatment, radical prostatectomy was performed 3 weeks later (±7 days).
Drug: Geranium wilfordii combined with androgen deprivation treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pCR or MRD rate
Time Frame: up to 4 weeks
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;
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PSA level change
Time Frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
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
up to 4 weeks
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)
The evaluation period was up to 1 year ( from the date of completion of surgery to the date of first recorded psa progression)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

baotai Liang

Investigators

  • Study Director: Vice President of Zhongda Hospital, Zhongda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2025

Primary Completion (Estimated)

March 10, 2026

Study Completion (Estimated)

March 10, 2027

Study Registration Dates

First Submitted

March 2, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024ZDSYLL512-Y01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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