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

Castration-resistant Prostate Cancer Clinical Trial

Official title:

One-arm, Multi-center Clinical Trial of Paclitaxel (Albumin-binding) Combined With Carboplatin for Castration-resistant Prostate Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04148885
• Other study ID #: CSPC-KAL-PC-01
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: November 2019
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Li Qi, MD PHD
• Phone: +8618121288167
• Email: Leeqi2001[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Prostate cancer is one of the most common malignant tumors of the male genitourinary system. In 2017, the American Oncology Society will report that 161,360 new prostate cancers were estimated, accounting for 21% of male tumors, ranking first in male new tumors; 26,730 death, cancer death. The rate is second only to bronchial lung cancer and colorectal cancer. In China, although the incidence of prostate cancer is lower than the world epidemiological level, the incidence of prostate cancer in China has shown an increasing trend in recent years. The latest statistics from the National Cancer Center 2017, the incidence of male prostate cancer is 2.4%, which is a male malignant tumor. Seventh place in the disease. The taxane drug docetaxel showed good anti-tumor activity in castration resistant prostate cancer (CRPC) patients, and paclitaxel combined with carboplatin also had a certain effect on CRPC. However, in clinical practice, patients with prostate cancer are mostly old, often accompanied by other underlying diseases, poor physical status, and poor tolerance in the use of docetaxel and paclitaxel. Albumin-bound paclitaxel has more tumor-targeted enrichment than traditional paclitaxel and is less toxic. Therefore, this study intends to explore the efficacy and safety of albumin-bound paclitaxel combined with carboplatin in the treatment of CRPC, providing a reference for the treatment options of CRPC in clinical practice.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• nab-paclitaxel
Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
• carboplatin
Patients secondly receive carboplatin AUC=5 (iv, 30 minutes) on days 1 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate specific antigen (PSA)	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.	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
Secondary	ORR	Objective Response Rate	From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter
Secondary	TTF	Time to treatment failure	From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter
Secondary	OS	Overall survival	From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter