Clinical trial · Interventional
A Trial of Paclitaxel (Albumin-binding) for Castration-resistant Prostate Cancer
One-arm, Multi-center Clinical Trial of Paclitaxel (Albumin-binding) Combined With Carboplatin for Castration-resistant Prostate Cancer
NCT04148885CI-TRIAL-00041420unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
One-arm, multi-center clinical trial of paclitaxel (albumin-binding) combined with carboplatin for castration-resistant prostate cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nab-paclitaxel + Carboplatin
- description
- nab-paclitaxel at 260 mg/m\^2 on days 1; Carboplatin AUG=5, d1, 21 days in one cycle, 3 cycles in total
- interventionNames
- Drug: nab-paclitaxel
- Drug: carboplatin
Primary outcomes (1)
- measure
- Prostate specific antigen (PSA)
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
- description
- PSA was effective: PSA decreased by ≥ 50% for more than 4 weeks, and there was no evidence of clinical and imaging progression; PSA progression: PSA increased more than 25% of baseline or baseline during chemotherapy, and the absolute value was ≥ 5 ng/ml.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.