Prostate cancer
Conditions
Interventions
Experimental group:Revalutamide Combined with ADT
Control group:Placebo Combined with ADT
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>= 18 years old, histologically confirmed adenocarcinoma of the prostate. 2. Prior radical prostate cancer resection, before randomization, meet any of the following: (1) PSA must be > 0.1ng/mL within 4-8 weeks after radical prostatectomy; (2) PSA >=0.5 ng/mL in subjects with biochemical recurrence. 3. Abdomen/pelvis screening CT or MRI and radionuclide whole-body bone scan with no clear evidence of metastasis, as judged by the investigator, are allowed to be positive for abdominal and/or pelvic lymph nodes with a short-axis diameter of 2 cm or less. Lesions found on other imaging modalities (e.g., PSMA or choline PET) are allowed but not visible on CT and/or MRI or radionuclide bone scan. 4. Before enrollment, the subject has been assessed by the investigator to have contraindications to radiotherapy, is not suitable for radiotherapy, or cannot recover from urinary continence after prostate cancer surgery, or is unwilling to undergo radiotherapy (subjects with high-risk biochemical recurrence have previously undergone radical resection of prostate cancer, and adjuvant radiotherapy or salvage radiotherapy after radical resection of prostate cancer are allowed to be enrolled). 5. Performance status (ECOG) score 0-1. 6. Have at least one high-risk feature: T3-4, ISUP grade 4 or 5, preoperative PSA >=20ng/mL, positive resection margin, positive lymph node. 7. Serum testosterone > 150 ng/dL during the screening period. 8. The functional level of the organ must meet the following requirements (no blood transfusion or hematopoietic growth factor therapy within 2 weeks prior to routine blood screening): •Neutrophil count (ANC) >=1.5×10^9/L (no granulocyte colony-stimulating factor support in the two weeks prior to Cycle 1, Day 1); •Platelet count (PLT) >= 100×10^9/L (no transfusion in the two weeks prior to Cycle 1, Day 1); •Hemoglobin (Hb) >= 90 g/L •Serum creatinine (Cr) 50 mL/minute; •Total bilirubin (BIL) =50 percent; 9. Male subjects whose partner is a female of childbearing potential who agrees to use effective contraception during the trial and for 3 months after the last administration of the study drug, and sperm donation is not allowed during this period. 10.Subjects voluntarily participate in this clinical trial, understand the study procedures and are able to comply with the scheduled visits, treatment plans, laboratory tests, and have signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous or existing abdominal/pelvic screening CT or MRI and radionuclide whole-body bone scan with clear evidence of metastasis. 2. Prior androgen deprivation therapy and/or first-generation antiandrogens (e.g. bicalutamide, nilutamide, flutamide) for prostate cancer. Prior ADT and/or first-generation anti-androgens in the (neo)adjuvant and/or salvage setting before, during, and/or after surgery are permitted, provided that the last effective dose of ADT and/or first-generation antiandrogens > 9 months prior to the date of randomization and that the total duration of prior therapy = Grade 3). 12. Requires systemic treatment or uncontrolled active infection. 13. Patients with active HBV and HCV infection (HBV virus copy number>= 10^4 copies/mL, HCV virus copy number>=10^3 copies/mL). 14. History of immunodeficiency (including positive HIV test, other acquired and congenital immunodeficiency diseases) or organ transplantation. 15. Subjects judged by the investigator to be likely to affect the conduct of clinical research, may not be able to comply with the protocol or cannot cooperate, and subjects with research risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA-PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Metastasis-free survival;Time to CRPC;Three-year progression-free survival rate of PSA;Overall survival;Time to PSA < 0.1ng/mL;Time to the use of the new anti-tumor treatment;Safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactYuanjie Niu
The Second Hospital of Tianjin Medical University
Outcome results
None listed