A prospective open label, randomized, multi-centre, parallel design, controlled study to evaluate the efficacy and safety of DNANOPAURONA herbal formulation prepared using green nanotechnology to treating castration resistant prostate cancer

Dhanvantari Nano Ayushadi Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patient with adenocarcinoma of the prostate and histologically proven metastatic castration-resistant stage, defined by: objective progression of at least one measurable tumor target and / or assessable by RECIST, and / or increase in PSA (rising PSA)
•2.Patient willing to participate by providing written informed consent
•3.Life expectancy must be >= 6 months
•4.Randomization should occur less than 120 days after prostatectomy & lymphadenectomy.
•5.ECOG performance status with 0 or 1
•6.Laboratory value must be as follows:
•White Blood Cells >= 3,000/mm3
•Neutrophils >= 2,000/mm3
•Hemoglobin >= 8 g/dL
•Platelets >= 100,000/mm3
•Serum creatinine <=1.5 Ã? Upper normal limit (UNL)
•Alkaline phosphatase <=1.5 Ã? Upper normal limit (UNL)
•Total serum bilirubin <= 1.5 Ã?UNL for the institution.
•AST <=1.5 Ã? Upper normal limit (UNL)
•ALT <=1.5 Ã? Upper normal limit (UNL)
•Serum Calcium <= ULN
•Serum testosterone >= 150ng/dL within 6 months prior to randomization
•7.Subject must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study.

•1.Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.
•2.History of a malignancy other than prostate cancer
•3.Participants taking alternative therapies for cancer must stop taking these therapies prior to screening. Alternative therapies are not allowed during the treatment or follow-up portions of the study.
•4.Peripheral neuropathy >= Grade 2.
•5.Electrocardiogram (ECG) with significant abnormalities (as determined by the investigator)
•6.Participants who are medically unstable, including but not limited to active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome.
•7.Positive Serological test for HIV, viral hepatitis (B, C).
•8.History of drug or alcohol dependence or abuse during the last 1 year prior to randomization
•9.Have participated in an investigational trial within 30 days prior to enrollment.

发起方

Dhanvantari Nano Ayushadi Private Limited