Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: Response assessment with Androgen deprivation therapy + abiraterone + prednisolone in mHSPC: The process of randomization will begin once patient is diagnosed with metastatic hormone se
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the prostate with no prior systemic treatment. 2. Evidence of metastatic disease on PSMA PET-CT or extra-pelvic nodal metastases (greater than 2 cm, or more than 1 cm with associated pelvic node more than 2 cm). 3. Age above 18 years, ECOG performance status 0 and 1, and life expectancy of more than 6 months. 4. Hematology values: Hemoglobin above 10.0, Platelet count more than 100,000, Neutrophil more than 1.5 lac. 5. Biochemical values: Renal function: serum creatinine less than 1.5 times the upper normal limit or a calculated creatinine clearance more than 60 mL/min, Serum potassium more than 4 mmol/L, Liver function: Serum bilirubin less than 1.5 x ULN (except for patients with documented Gilbert?s disease), AST and ALT less than 1.5 x ULN (and less than 5 times the upper normal limit in case of liver metastases), ALP less than 2.5XULN (in case of bone metastasis, ALK-P less than 1000U/L if bilirubin is normal) 6. Clinically fit and eligible to receive docetaxel per standard guidelines and drug labeling. 7. Signed informed consent after receiving full study information. 8. Willingness and ability to comply with treatment, follow-up, and study procedures.
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy or biological therapy for prostate cancer. 2. Chronic medical conditions requiring corticosteroids dosing more than 10 mg/day prednisone (or equivalent), or contraindications to corticosteroid use. 3. Active viral hepatitis, symptomatic liver disease, or history of pituitary/adrenal dysfunction (except Gilbert?s syndrome). 4. Uncontrolled hypertension (SBP more than 160 mmHg or DBP more than 95 mmHg despite treatment). 5. Clinically significant heart disease: recent MI, thrombotic events (within 6 months), unstable angina, NYHA Class II?IV heart failure, EF less than 50%, atrial fibrillation or arrhythmias requiring therapy. 6. Hypersensitivity to docetaxel, abiraterone, or related compounds. 7. Presence of cystoid macular oedema or significant ophthalmologic disease contraindicating docetaxel. 8. Concomitant use of strong CYP3A4 inhibitors (clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiological Progression-Free Survival (rPFS) demonstrated by PSMA PET CT scanTimepoint: Follow up of 1 year after initiating therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare PSA response between patients receiving ADT + Abiraterone and those receiving ADT + Abiraterone + Docetaxel. 2. To compare the time to PSA progression between the two groups 3. To compare the safety and adverse event profiles between the two groups.Timepoint: Follow up of 1 year after initiating therapy | — |
Countries
India
Contacts
Public ContactRahil Kumar
All India Institute of Medical Sciences
Outcome results
None listed