Health Condition 1: null- castration resistant prostate cancer
Conditions
Interventions
Intervention1: Docetaxel Injection: Docetaxel Injection - 75 mg/m2 every 3 weeks as a 1 hour intravenous infusion
Control Intervention1: Docetaxel Injection and DNANOPAURONA: Docetaxel Injection - 7
Sponsors
Dhanvantari Nano Ayushadi Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 Alkaline phosphatase Total serum bilirubin AST ALT Serum Calcium 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.NCI Toxicity Criteria at every Course. 2.Prostate-specific antigen (PSA) response and PSA control in patients undergoing therapy, PSA levels will be evaluated monthly. Timepoint: 1.Visit 1 (Week -2) to Visit 6 (Week 12) 2.Visit 1 (Week -2) to Visit 6 (Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy of the DNANOPAURONA in terms of response rate in participating prostate cancer assessed by Radiographic Evaluation by RECIST Criteria. 2.Improvement in quality of life comparing baseline with end of study. 3.Improvement in Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire comparing baseline with end of study Timepoint: 1.Visit 1 (Week -2) to Visit 6 (Week 12) 2.Visit 2 (Week 0) to Visit 6 (Week 12) 3.Visit 2 (Week 0) to Visit 6 (Week 12) | — |
Countries
India
Contacts
Public ContactMs Vidya
Dhanvantari Nano Ayushadi Private Limited
Outcome results
None listed