Prostate cancer
Conditions
Interventions
The group treated with farsufilide hydrochloride combined with PD1 inhibitor and androgen deprivation therapy:On days 1 to 5, fluoxetine hydrochloride (10mg intravenous infusion) was administered. On
The placebo combined with androgen deprivation therapy group:On days 1 to 5, the patients were treated with placebo (10mg of 0.9% sodium chloride by intravenous infusion). On day 5, they were given pl
Sponsors
The Affiliated Zhongda Hospital of Southeast University
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years and <= 85 years; 2. Histologically confirmed as prostate cancer, without small cell characteristics; 3. Clearly diagnosed as metastatic prostate cancer through imaging examinations, with no more than 5 oligometastatic lesions (bone or lymph node metastases) or stage cT3-4; 4. ECOG (Eastern Cooperative Oncology Group) score is 0-1; 5. All patients voluntarily signed the informed consent form and were able to cooperate with treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Any previous or ongoing treatment for PCa, including radiotherapy, chemotherapy, ADT, etc.; 2.Patients who have previously undergone prostatectomy; 3. Any other serious underlying medical, mental, or psychological conditions that, based on the investigator's judgment, may affect the treatment; 4. Patients who are allergic to the administered drugs; 5. Patients who refuse to undergo radical prostatectomy; 6. Patients who, based on the investigator's judgment, are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of pCR or MRD;Biochemical progression-free survival after radical prostatectomy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PSA level; | — |
Countries
China
Contacts
Public ContactBin Xu
The Affiliated Zhongda Hospital of Southeast University
Outcome results
None listed