A Trial of Paclitaxel (Albumin-binding) for Castration-resistant Prostate Cancer

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

One-arm, multi-center clinical trial of paclitaxel (albumin-binding) combined with carboplatin for castration-resistant prostate cancer

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Age ≥18 years, Male;

• diagnosed as prostate cancer by histopathology or cytology;

• Confirmed as castration-resistant prostate cancer: 1 interval 1 week, 3 consecutive PSA minimum values increased by >50%; 2 serum testosterones <50ng/dl or <1.7nmol/L [Guide of the Chinese Urological Association (2015) The diagnostic criteria of CRPC];

• There are no other concurrent anti-cancer treatments (including local radiotherapy, systemic chemotherapy, and molecular targeted therapy) or previous treatment history;

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;

• The estimated survival period is more than 3 months;

• having at least one measurable lesion according to the RECIST 1.1 tumor evaluation criteria;

• No obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment;

• Liver function test: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤2.5 times the upper limit of normal value, if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance rate ≥50ml/min;

• Understand the circumstances of this study, patients and/or legal representatives voluntarily agree to participate in the trial and sign informed consent.

Exclusion Criteria:

• • Have a birth plan during the clinical trial;

• Patients with brain metastases;

• Severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs Intervention;

• Dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire;

• Subjects with ≥1 peripheral neuropathy according to CTCAE V version 4.03;

• Allergy or hypersensitivity history of the drug or drug ingredient used in this test;

• Excluding other malignant tumors, cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or any other part of the carcinoma in situ;

• Have received any other test drug treatment or participated in another interventional clinical trial within 30 days of the screening period;

• The investigator believes that it is not suitable for inclusion.