Health Condition 1: null- Advanced and/or Metastatic Prostate Cancer
Conditions
Interventions
Intervention1: Bicalutamide Tablet: Bicalutamide 50 mg Tablet once daily for duration of 180 days.
Control Intervention1: NIL: NIL
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.A potential subject willing to give written informed consent on his own or LAR/Impartial witness in case of an illiterate subject 2.Subjects entering the study should be greater than or equal to 18 Years and less than 80 Years of age. 3.Subjects entering the study should be clinically and histopathologically confirmed as diagnosed with advanced / metastatic prostate cancer. 4.Subjects participating in the study should agree to use effective contraception, in order to avoid female partner pregnancy. 5.Subjects participating in the study should have a baseline Serum PSA titre of greater than or equal to 10 ng/ml. 6.Subjects who have undergone prior radiotherapy and/or surgery can be included in the study provided, the radiotherapy and/or surgery has occurred at least 4 weeks prior to the initiation of treatment with the study drug. 7.Subjects participating in the study should have adequately controlled diabetes or cardiovascular disease, if suffering from any. 8.Subjects entering the study should have Hematology Profile specifications as follows: Hemoglobin (Hb) greater than 9.0 gm / dl, Platelete greater than or equal to 1, 00,000/ cumm. 9.Subjects entering the study should have clinical chemistry specifications as follows: Hepatic Profile (Bilirubin, Total Bilirubin less than or equal to 1.5 (times ULN), Alanine Transaminase (ALT) less than or equal to 2.5 times ULN, Aspartate Transaminase (AST) less than or equal to 2.5 times ULN, and Renal Functions (Serum Creatinine less than or equal to 1.5 times (ULN). 10.ECOG Performance Status of less than or equal to 2. 11.Subjects participating in the study should have a life expectancy of at least 6 months as per the investigators discretion. 12.Subjects who are surgically castrated will be included in the study. 13.Potential subjects should be willing to comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects with any clinically significant lab test and co-morbidity including any concurrent disease that could affect the patients? safety, as per the Investigator?s discretion. 2.Subjects with known Central Nervous System (CNS) metastasis, having a clinically stable disease of at less than 8 weeks prior to the administration of the study drug (A patient with known CNS metastasis and having a clinically stable disease of 8 weeks or more can be included in the study.) 3.Subjects under concurrent therapy with any other non-protocol anti-cancer therapy, including hormonal therapy or any other systemic anti-cancer therapy. 4.Subjects under treatment for ANY Acute Urinary Tract Infection (UTI) or any other active clinically significant systemic infections. 5.Subjects who are known to be hypersensitive to the study drug or to any of the excipients. 6.Subjects who have been on the investigational drug within 30 days, prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in circulating PSA levels as compared to baseline in patients of Prostate Cancer undergoing treatment with Bicalutamide.Timepoint: At Visit 4(Day90) and Visit 7 (Day180). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage of subjects, who achieve complete or partial response as compared to baseline, assessed for overall response as per RECIST Version 1.1 using imaging studies (CT/MRI) at Visit 4(Day90) and Visit 7 (Day180).Timepoint: At Visit 4(Day90) and Visit 7 (Day180).;1.Quality of Life using VAS for Pain.Timepoint: At Visit 3 (Day 60), visit 5 (Day120), visit 7 (Day180) and visit 8 (Day195);1.Safety of the study drug will be estimated from type, number, frequency and percentage of subjects with AE(s)Timepoint: During entire study period.;2.Percentage of subjects who achieve Time to progression (TTP) defined as the time from the start of treatment to the date of documented progression, assessed for overall response as per RECIST Version 1.1 using imaging studies (CT/MRI) at Visit 4(Day90) and Visit 7 (Day180).Timepoint: At Visit 4(Day90) and Visit 7 (Day180).;3. To evaluate Progression Free Survival (PFS) defined as; the time from the start of treatment to the end of the treatment with no worsening of the disease condition.Timepoint: At Visit 4(Day90) and Visit 7 (Day180).;4.Percentage reduction in Bone Marker Levels (Bone Fraction Serum Alkaline Phosphatase and Serum Calcium) at visit 4(day 90) and Visit 7(day 180) compared to baseline valuesTimepoint: At Visit 4(Day90) and Visit 7 (Day180).;7.Treatment Emergent Adverse Events (TEAE defined as an AE which is definitely or probably related to study medication) as per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.02.Timepoint: During entire study period. | — |
Countries
India
Contacts
Public ContactDr Sadashiv Bhole
Associate Director Medical Affairs & Safety
Outcome results
None listed