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

ConditionProstate CA
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
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 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.

Eligibility criteria

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

Treatments tested in this trial

  • Geranium wilfordii combined with androgen deprivation treatment
  • Androgen deprivation treatment
  • radical prostatectomy

Treatment groups

95 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

baotai Liang

Lead sponsor

Zhongda Hospital

Sponsor institution