| 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) |
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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 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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).
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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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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