Prostate Cancer
Conditions
Interventions
Trial group:1. Gemcitabine: 1000 mg/m^2, administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle, with a maximum duration of 8 cycles.
Dose adjustment: It is recommended to com
if the patient experiences gemcitabine-related adverse reactions (e.g., febrile neutropenia, peripheral neuropathy, diarrhea), the following adjustments may be made: (1) Temporary interruption: Resume
up to two dose reductions are permitted, with a minimum dose of 500 mg/m^2. (3) Permanent discontinuation: If intolerable adverse events persist after dose reduction (e.g., persistent Grade 2 or highe
dose reduction is not allowed. Specific requirements: If the patient experiences treatment-related adverse reactions (e.g., immune-mediated pneumonitis, thyroid dysfunction), administration may be int
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male, aged >= 18 years. 2. Histologically or cytologically confirmed prostatic adenocarcinoma, without small cell histology. 3. Evidence of current distant metastatic disease (Stage M1) confirmed by bone lesions detected on bone scan and/or soft tissue lesions detected by computed tomography/magnetic resonance imaging (CT/MRI). 4. Received medical or surgical castration therapy with a serum testosterone level = 2 weeks before enrollment. If the patient discontinued treatment due to intolerance (e.g., enzalutamide-related rash), the treatment must be discontinued for >= 1 week and the adverse event (AE) must resolve to = 4 weeks, developed adverse events clearly related to the drug (referring to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), and met the following criteria: 1) Adverse event grade >= 3; 2) Persistent Grade 2 CTCAE adverse event (>= 2 weeks) that cannot be relieved despite symptomatic treatment (e.g., antiemetics, liver protection) or dose reduction (= 50 mL/min (calculated according to the Cockcroft-Gault formula); (4) Bone marrow function: absolute neutrophil count >= 1.5 × 10^9/L, platelet count >= 100 × 10^9/L, hemoglobin >= 90 g/L. 9. Blood tests before enrollment confirm the integrity of major organ functions. 10. Voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received other anti-tumor monoclonal antibody therapy within 4 weeks before enrollment, or adverse events related to anti-tumor monoclonal antibody therapy (received more than 4 weeks before enrollment) have not resolved. 2. Received major surgery (including local prostate intervention, excluding prostate biopsy) within 28 days before enrollment and has not recovered from toxic reactions and/or complications. 3. Patients who have previously received or are currently using drugs that may affect or interfere with subsequent research (e.g., targeted small-molecule therapy). 4. Patients with a history of allergy or contraindication to gemcitabine or toripalimab. 5. Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis. 6. Other previous or concurrent malignant tumors, except for the following cases: (1) Malignant tumors that have been cured for 5 years with no evidence of recurrence (e.g., cutaneous basal cell carcinoma); (2) Locally curable malignant tumors that have been cured (e.g., papillary thyroid carcinoma with no recurrence for 2 years after surgery). 7. Concurrent other severe systemic diseases (e.g., myocardial infarction within 6 months, New York Heart Association (NYHA) Class III-IV heart failure), active autoimmune diseases (e.g., systemic lupus erythematosus requiring long-term use of immunosuppressants), which may interfere with the treatment, evaluation, or compliance of this study. 8. Patients participating in an ongoing clinical study or who have completed any other study for less than 6 months. 9. Vulnerable groups, including patients with mental illness, cognitive impairment, critically ill patients, etc.: (1) Patients with acute mental illness (e.g., acute episode of schizophrenia); (2) Patients with severe cognitive impairment (Mini-Mental State Examination (MMSE) score < 20); (3) Critically ill patients with a life expectancy of < 3 months; (4) Populations unable to understand the content of the informed consent through auxiliary means (e.g., verbal explanation, witness, graphic manual). Note: For illiterate/elderly patients, they must be accompanied by a witness and/or guardian. Researchers shall explain the content of the informed consent clause by clause verbally. After confirming understanding, the patient shall affix a fingerprint and the witness shall sign for confirmation. 10. Patients positive for hepatitis B surface antigen (HBsAg), unless HBsAg-positive subjects have received HBV antiviral therapy for at least 4 weeks before randomization and have undetectable HBV viral load (they are eligible to participate in the study). Note: Subjects should continue to receive antiviral therapy throughout the study intervention period and follow local HBV antiviral therapy guidelines after completing the study intervention. 11. Other conditions deemed unsuitable for participation in the study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA50 Response Rate;Time to prostate-specific antigen (PSA) progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Radiographically progression-free survival;The number of adverse events (AEs) and the number of subjects who discontinued study treatment due to adverse events (AEs); | — |
Countries
China
Contacts
Public ContactChen Yicheng
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed