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

Phase 3

• Conditions: Health Condition 1: null- castration resistant prostate cancer

• Registration Number: CTRI/2018/05/013553
• Lead Sponsor: Dhanvantari Nano Ayushadi Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

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 <=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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.NCI Toxicity Criteria at every Course. <br/ ><br>2.Prostate-specific antigen (PSA) response and PSA control in patients undergoing therapy, PSA levels will be evaluated monthly. <br/ ><br>Timepoint: 1.Visit 1 (Week -2) to Visit 6 (Week 12) <br/ ><br>2.Visit 1 (Week -2) to Visit 6 (Week 12)

Secondary Outcome Measures

Name	Time	Method
1.Efficacy of the DNANOPAURONA in terms of response rate in participating prostate cancer assessed by Radiographic Evaluation by RECIST Criteria. <br/ ><br>2.Improvement in quality of life comparing baseline with end of study. <br/ ><br>3.Improvement in Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire comparing baseline with end of study <br/ ><br>Timepoint: 1.Visit 1 (Week -2) to Visit 6 (Week 12) <br/ ><br>2.Visit 2 (Week 0) to Visit 6 (Week 12) <br/ ><br>3.Visit 2 (Week 0) to Visit 6 (Week 12)