prostate cancer
Conditions
Interventions
LHRHa:Standard radical radiotherapy or postoperative radiotherapy combined with LHRHa.
revirumide:Standard radical radiotherapy or postoperative radiotherapy combined with LHRHa and revirumide
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: - Male, aged =18 years (inclusive); - Newly diagnosed and pathologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features at initial biopsy; - No distant metastases confirmed by bone scan, whole-body MRI, or PET-CT imaging; - Undergoing radical radiotherapy or postoperative radiotherapy; - Lymph node-positive; Or if lymph node-negative and undergoing radical radiotherapy, meets at least two of the following conditions: (=T3a, Gleason score 9-10, PSA =20 ng/mL); Or if lymph node-negative and undergoing postoperative radiotherapy after radical surgery, experiences biochemical recurrence (PSA =0.2 ng/mL) and meets at least one of the following high-risk recurrence factors (PSADT <3 months, =T3a, Gleason score 9-10, or local recurrence/residual tumor, or lymph node recurrence); - Willing to participate in the study and sign an informed consent form; - Able to swallow the study drug and comply with study requirements; - Expected survival =12 weeks; - European Cooperative Oncology Group (ECOG) performance status score of 0 or 1; - Sufficient cardiac, bone marrow, liver, and kidney function; - Willing and able to comply with the trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: - Underwent major surgery within 4 weeks before enrollment (except radical prostatectomy); - Absolute neutrophil count 2 mg/dL (177 µmol/L); - Albumin < 3.0 g/dL (30 g/L); - Gastrointestinal dysfunction affecting absorption; - Contraindications for using LHRH analogs, such as previous allergic reactions to any components of LHRH analogs; - Other severe, uncontrolled comorbid conditions that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or progressive (severe) infections, uncontrolled diabetes, uncontrolled hypertension, cardiovascular disease (heart failure defined by New York Heart Association classification III or IV, second-degree or higher heart block, myocardial infarction within the past 12 months, unstable arrhythmias or unstable angina, stroke within the past 6 months), or pulmonary disease (interstitial pneumonia, obstructive pulmonary disease, and a history of symptomatic bronchospasm), deep vein thrombosis, or pulmonary embolism within the past 6 months; - History of other malignancies within 5 years before enrollment, except for the following: malignancies expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, basal or squamous cell skin cancer); - Estimated insufficient compliance to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA decline ratio at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| biochemical recurrence free survival;rPFS;Time to change the treatment strategy;metastasis free survival;Side effective; | — |
Countries
China
Contacts
Public ContactXianshu Gao/Wei Yu
Peking University First Hospital
Outcome results
None listed