Prostate cancer
Conditions
Interventions
Experimental group:lopinavir-ritonavir tablets
Sponsors
Xiangya Hospital of Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Male, aged >=18 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1; 3. Estimated life expectancy >=3 months; 4. Histologically or cytologically confirmed adenocarcinoma of the prostate, with no evidence of neuroendocrine or small cell features; 5. Presence of radiographically confirmed lesions; 6. Ongoing luteinizing hormone-releasing hormone analog (LHRHa) therapy (medical castration) or prior bilateral orchiectomy (surgical castration); patients who have not undergone bilateral orchiectomy must maintain effective LHRHa therapy within 4 weeks prior to the first dose of the study drug and throughout the study; 7. Castrate levels of testosterone at screening (=1 week between tests) and a PSA level of >=1 ng/mL at screening; (2) Disease progression as defined by RECIST 1.1; (3) Bone disease progression as defined by PCWG3 criteria, indicated by >=2 new bone lesions on bone scan, with ambiguous results confirmed by another imaging modality (e.g., CT or MRI); 9. Prior treatment requirements: Progression of disease following at least one prior approved novel hormonal agent (NHA) during the CRPC stage (e.g., enzalutamide, apalutamide, or abiraterone); patients who have received first-generation antiandrogens (e.g., bicalutamide, flutamide, or nilutamide) may be enrolled, but first-generation antiandrogen therapy is not considered a novel hormonal therapy. Patients must have discontinued first-generation antiandrogens at least 28 days prior to enrollment; 10. Adequate organ function as defined by the following criteria (no blood transfusions or hematopoietic growth factor support within 2 weeks before hematology screening): (1) Absolute neutrophil count (ANC) >=1.5×10^9/L; (2) Platelet count (PLT) >=80×10^9/L; (3) Hemoglobin (Hb) >=90 g/L; (4) Total bilirubin (TBIL) =51 mL/min; 11. Patients deemed capable of ejaculation and sexually active by the investigator must agree to use effective contraception (including one barrier method) and refrain from sperm donation from the first dose of the study drug until 3 months after the last dose; 12. Voluntarily participates in this clinical trial, understands the study procedures, and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria will be ineligible for this study: 1. Any disease or condition that, in the investigator's judgment, would interfere with the evaluation of the study treatment or pose a risk to the participant's safety or interpretation of study results; 2. Participants receiving bisphosphonates or denosumab for bone metastases or bone-related diseases with irregular dosing within 4 weeks prior to the first administration of the study drug; 3. Participants who received palliative radiotherapy or major surgery (Grade 3–4 as assessed by the investigator) within 2 weeks prior to the first administration of the study drug, or who participated in another drug clinical trial within 4 weeks prior to the first administration; 4. Receipt of large molecule antineoplastic therapies (including immunotherapies such as monoclonal antibodies and bispecific antibodies) within 28 days before the first administration of the study treatment; 5. Use of herbal remedies that may reduce PSA levels (e.g., saw palmetto) or systemic steroids within 4 weeks prior to the first administration, or planned use of such medications during the trial (excluding temporary steroid use for allergy prevention or treatment); 6. Plans to receive any antitumor therapy other than the protocol-specified treatments during the study; 7. Evidence of brain or central nervous system metastases; 8. Severe bone damage due to prostate cancer bone metastasis, as assessed by the investigator, including poorly controlled severe bone pain, pathologic fractures in critical locations occurring or expected within 6 months prior to the first administration, or spinal cord compression; 9. Concurrent pituitary or adrenal dysfunction not adequately managed; 10. Uncontrolled hypertension (persistent systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg). Participants with a history of hypertension may participate if blood pressure is controlled by antihypertensive treatment; 11. Curative treatment for malignancies with no known active disease and low potential for recurrence at least 2 years before the first administration of the study treatment; 12. Residual toxicities from prior antitumor therapies at grade >=2 as per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (excluding alopecia and residual neurotoxicity); 13. History or current diagnosis of vesicovaginal fistula, colovaginal fistula, or rectovaginal fistula; 14. Active or prior history of autoimmune or inflammatory diseases (including but not limited to inflammatory bowel diseases [e.g., colitis or Crohn's disease], diverticulitis [excluding diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, non-infectious pneumonitis [including a history of ILD, drug-induced ILD, or radiation pneumonitis requiring steroid treatment], or any clinical evidence of active ILD). Exceptions to this criterion include: (1) Vitiligo or alopecia; (2) Participants with hypothyroidism (e.g., due to Hashimoto's thyroiditis) stable on hormone replacement therapy; (3) Chronic skin conditions that do not require systemic therapy; (4) Participants with no active disease in the past 5 years may be included after consultation with the clinical investigator; (5) Participants with celiac disease controlled by diet alone; 15. Uncontrolled comorbid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYi Cai
Xiangya Hospital of Central South University
Outcome results
None listed