Comparison of therapeutic efficacy between two different treatment methods in patients with prostate cancer

Phase 2

Conditions: Health Condition 1: null- prostate cancer patients who have failed hormonal andchemotherapy

Registration Number: CTRI/2018/07/014703

Lead Sponsor: All India Institute of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients with histologically or cytologically confirmed adenocarcinoma of prostate.

2. Patients with disease progression in spite of androgen deprivation therapy or chemotherapy.

3. sPSA > 5ng/ml

4. Surgically or medically castrated

5. 68Ga-PSMA PET/CT showing sites of PSMA expressing disease

6. Patients ECOG performance status <= 3

7. Patients Karnofsky performance status of >= 60

8. Patients with GFR level >= 60 ml/min

9. Heamoglobin >= 9.5 gm/dL

10. Platelet count >150,000 cells/mm3

11. WBC count >4000/cu.mm

12. Normal KFT( Kidney Function Test) and LFT (Liver Function Test)

13. Willing to take abiraterone on an empty stomach

14. No previous history of prior radionuclide therapy

15. At least four weeks gap between prior surgery or radiotherapy

Exclusion Criteria

1. Negative Ga68-PSMA scan or bone scan

2. Known allergies, hypersensitivity or intolerance to abiraterone acetate prednisone or their excipients

3. Uncontrolled hypertension

4. Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose.

5.History of pituitary or adrenal dysfunction

6. Bicalutamide, nilutamide within 6 weeks of cycle 1, day 1

7. Anticipated life expectancy of less than 6 months

8. Patients with history of prior cardiac disease

9. Abnormal amino transferase levels;

> 2.5 times the upper value of the normal rangesin patients without liver metastases

< 5 times the upper value of the normal range in patients with known liver metastasis

10. Active or symptomatic viral hepatitis or chronic liver disease patients

11. History of a different malignancy except for the following circumstances: disease-free survival for at least 5 years and deemed by the investigator to b at low-risk for recurrence of that malignancy.

12. Patients not giving written informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survivalTimepoint: follow-up of all <br/ ><br>patients every <br/ ><br>quarterly

Secondary Outcome Measures

Name	Time	Method
â?¢Time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria) <br/ ><br>â?¢Progression-free survival according to radiologic findings based on pre-specified criteria, and the PSA response rate <br/ ><br>â?¢Objective responseTimepoint: follow-up of all <br/ ><br>patients every <br/ ><br>quarterly