Prostate Cancer
Conditions
Interventions
Experiment group:1.Eligible subjects will first undergo PSMA-PET/CT examination, followed by treatment with ADT combined with Nubeigo (Darolutamide) at a dose of 600 mg twice daily for a total of 3 to
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.An informed consent form has been provided prior to the start of any study procedures. 2.Age between 18 and 75 years (inclusive). 3.Good physical condition, with an ECOG performance status of 0-1, and no severe cardiovascular or psychiatric disorders. 4.Newly diagnosed prostate cancer (=6 months prior to randomization) with pathological confirmation of prostate adenocarcinoma. 5.Any T/N staging according to the AJCC 8th edition, with oligometastasis defined as =5 bone and/or pelvic lymph node lesions, without visceral metastasis. 6.Subjects have not previously received local treatment for primary prostate cancer and have no contraindications for radical prostatectomy. 7.Male subjects must have undergone surgical sterilization or use acceptable contraceptive methods (defined as barrier methods containing spermicide) during the study and for 3 months after the last administration of the study drug to prevent partner pregnancy. 8.Blood donors must not donate blood during the study and for 3 months after the last administration of the study drug. 9.During the study (including receiving treatment, participating in scheduled visits, and undergoing examinations), the subjects voluntarily and are capable of complying with the protocol.
Exclusion criteria
Exclusion criteria: 1.Staff involved in the program and/or conducting this research (research center staff) 2.Previously participated in the current study 3.Participated in a clinical study of another investigational product (IP) in the previous month 4.Previous surgical castration treatment or chemotherapy. 5.Subjects with a known hypersensitivity reaction to Darolutamide or any excipient in the product. 6.The investigator determines that the subject has a psychiatric or physical condition that would make it unsafe for them to receive treatment. 7.The investigator determines that the subject has any laboratory abnormalities that would place them at risk if they participate in the study. 8.Subjects with a history of cancer treatment resulting in persistent toxicity (greater than CTCAE grade 2), excluding alopecia. 9.Patients with known active hepatitis (i.e., hepatitis B or C) due to the risk of infection transmission through blood or other bodily fluids. 10.Subjects with immunodeficiency, such as those known to be seropositive for human immunodeficiency virus (HIV) 11.Subjects unwilling or unable to comply with the protocol requirements and participate in scheduled visits 12.Patients with surgical contraindications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiology progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathology Complete response;PSA-Progression free survival; | — |
Countries
China
Contacts
Public ContactBaoJun Wang
Chinese PLA General Hospital
Outcome results
None listed