Prostate cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male; 2. Aged 18 years and above; 3. Histologically confirmed prostate adenocarcinoma; 4. Clinical staging was recorded as T3 and T4 or N1 or M1 (pathological diagnosis, prostate MRI, whole body bone scanning, PET-CT); 5. The investigator assessed that triprorelin could be used or had been or was being treated with triprorelin; 6. Male subjects have undergone surgical sterilization or have used acceptable contraceptive methods (defined as barrier contraception containing spermicides) during the duration of the study and 3 months after the last administration of the study drug to prevent their partners from becoming pregnant; 7. During the duration of the study (including receiving treatment and participating in planned visits and examinations), the subjects were informed and agreed to participate in the study, and had the ability to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis of urothelial origin or intraductal carcinoma or sarcoma; 2. Previously undergone surgical castration treatment; 3. Subjects who are known to have hypersensitivity reactions to Daphnetin (Triproline Acetate Injection, Triproline Dihydroxynaphthalene Injection) or any excipient in the product; 4. The researcher determines that the subject has a mental or physical condition that makes it unsafe for them to receive treatment; 5. The researcher determines that the subject has any laboratory test abnormality that would put the subject at risk if they were to participate in the study; 6. Patients known to have active hepatitis (i.e. hepatitis B or C) are at risk of infection transmission through blood or other bodily fluids; 7. Subjects with immune dysfunction, such as those known to be seropositive for human immunodeficiency virus (HIV); 8. Refusal or inability to comply with the requirements of the plan and participate in planned visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accumulation of testosterone inhibition to castration levels during the study treatment period from the 28th day to the end of the study cycle probability; | — |
Secondary
| Measure | Time frame |
|---|---|
| EORTC QLQ-C30;IPSS; | — |
Countries
China
Contacts
The Fifth Affiliated Hospital of Xinjiang Medical University