Clinical Study of Geranium Wilfordii Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer
NCT06861166 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 95
Last updated 2025-03-06
Summary
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.
Conditions
- Prostate CA
Interventions
- 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
- DRUG
-
Androgen deprivation treatment
Continuous androgen deprivation therapy
- PROCEDURE
-
radical prostatectomy
After completion of treatment, radical prostatectomy was performed 3 weeks later (±7 days).
Sponsors & Collaborators
-
baotai Liang
lead OTHER
Principal Investigators
-
Vice President of Zhongda Hospital · Zhongda Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-10
- Primary Completion
- 2026-03-10
- Completion
- 2027-03-10
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