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CTRI Number  CTRI/2025/09/093977 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 31/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to compare the effect of ADT with abiratarone versus ADT with abiratarone with chemotherapy (docitaxel) 
Scientific Title of Study   Randomized control trial comparing ADT with abiraterone versus ADT with abiraterone and docetaxel in denovo metastatic hormone sensitive prostate cancer: A pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahil Kumar 
Designation  Senior resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Urology, All India Institute of Medical Sciences, Ansari nagar east, New Delhi - 110029

New Delhi
DELHI
110029
India 
Phone  9873864209  
Fax    
Email  rahilkr95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Brusabhanu Nayak 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Urology, All India Institute of Medical Sciences, Ansari nagar east, New Delhi - 110029

New Delhi
DELHI
110029
India 
Phone  9868449607  
Fax    
Email  brusabhanu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rahil Kumar 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Urology, All India Institute of Medical Sciences, Ansari nagar east, New Delhi - 110029

New Delhi
DELHI
110029
India 
Phone  9873864209  
Fax    
Email  rahilkr95@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Department of Urology, All India Institute of Medical Sciences, Sri Aurobindo marg, Ansari nagar east, New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rahil Kumar  All India Institute of Medical Sciences, New Delhi  5028, Urology office, Department of Urology
South
DELHI 
9873864209

rahilkr95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Postgraduate Research, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C61||Malignant neoplasm of prostate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Response assessment with Androgen deprivation therapy + abiraterone + prednisolone + Docitaxel in mHSPC  The process of randomization will begin once patient is diagnosed with metastatic hormone sensitive prostate carcinoma, based on PSMA PET CT scan and biopsy report. Patients will then receive Androgen deprivation therapy + Abiraterone + prednisolone + docitaxel and will be followed up. Response anssessment will be done every 3 monthly with serum PSA report and 6 monthly with PSMA PET CT scan till 12 months. Any adverse events will be managed according to the standard protocol. 
Intervention  Response assessment with Androgen deprivation therapy + abiraterone + prednisolone in mHSPC  The process of randomization will begin once patient is diagnosed with metastatic hormone sensitive prostate carcinoma, based on PSMA PET CT scan and biopsy report. Patients will then receive Androgen deprivation therapy with Abiraterone + prednisone and will be followed up. Response anssessment will be done every 3 monthly with serum PSA report and 6 monthly with PSMA PET CT scan till 12 months. Any adverse events will be managed according to the standard protocol. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Male 
Details  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. 
 
ExclusionCriteria 
Details  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).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Radiological Progression-Free Survival (rPFS) demonstrated by PSMA PET CT scan  Follow up of 1 year after initiating therapy 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
Follow up of 1 year after initiating therapy 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   11/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Eligible patients diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) meeting all inclusion and exclusion criteria will be approached for participation. Prior to enrollment, all participants will be thoroughly informed about the study objectives, procedures, potential risks and benefits using patient information sheet. Written informed consent will be obtained from each patient before any study-related procedures are initiated. A total of 50 patients with histologically confirmed metastatic hormone-sensitive prostate cancer (mHSPC) will be enrolled in the study. Patients will be randomly assigned in a 1:1 ratio to two treatment arms: Group A: ADT + Abiraterone (1000 mg/day) + Prednisolone (5 mg twice daily), Group B: ADT + Abiraterone (1000 mg/day) + Prednisolone (5 mg twice daily) + Docetaxel (75 mg/m² IV for 6 cycles). The process of randomization will begin once histopathology report of the primary TRUS guided biopsy is obtained. Randomization will be done using a computer-generated randomization schedule using block randomization technique. Sequentially numbered, opaque, sealed envelopes (SNOSE) will be used for allocation concealment. Both the treating surgeon and the patients will be aware of the management proposed. Patients will be block-randomized in a 1:1 ratio into two treatment arms: Group A: ADT + Abiraterone and Group B: ADT + Abiraterone + Docetaxel. Patients will be followed at regular intervals every 12 weeks for clinical assessment and laboratory monitoring, including PSA levels and adverse events. PSMA PET-CT will be repeated at 6 months and 12 months or earlier if biochemical or clinical progression is suspected. Patients will be followed for a minimum of 12 months or until disease progression, death, or withdrawal from the study. Systematic collection of data will be done using data collection sheet at baseline and at scheduled follow-up visits. This will include demographic details, clinical history and physical examination findings, laboratory values, imaging findings (including PSMA PET CT scans), treatment details, adverse events, PSA levels and progression, radiological assessments. All data will be anonymized and stored securely for analysis. After obtaining written informed consent, participants will undergo a series of basic investigations in accordance with institutional guidelines which are part of routine clinical practice. This will include complete blood count (CBC), renal function tests (serum creatinine and calculated creatinine clearance), liver function tests (bilirubin, AST, ALT, ALP), serum potassium levels, PSA levels, ECG and echocardiography for cardiac function (including ejection fraction), PSMA PET CT for staging and metastasis documentation, Ophthalmologic evaluation in patients with impaired vision.


 
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