| CTRI Number |
CTRI/2023/03/050180 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study of compairing benefit of Abiraterone low versus full dose with Docetaxel in Prostate Cancer |
|
Scientific Title of Study
|
DAHLIA: Docetaxel with Abiraterone full versus low dose in Hormone Sensitive
Advanced Prostate Cancer – Phase III, Non-Inferiority Randomized Control Open
Label Trial. |
| Trial Acronym |
DAHLIA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil kapoor |
| Designation |
Associate proessor,Department of Medical Oncology |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
| Address |
OPD No.28 Ground floor DNT Block,Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) Sundarpur Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9950482121 |
| Fax |
|
| Email |
kapoorakhil1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Bhavesh P Bandekar |
| Designation |
Scientific Officer Clinical Research Secretariat |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre,Sundar bagiya,Banaras Hindu University Campus,Sundarpur,Varanasi
Varanasi
UTTAR PRADESH
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08779187963 |
| Fax |
|
| Email |
bhavesh.bandekar1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Bhavesh P Bandekar |
| Designation |
Scientific Officer Clinical Research Secretariat |
| Affiliation |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) |
| Address |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre,Sundar bagiya,Banaras Hindu University Campus,Sundarpur,Varanasi
Varanasi
UTTAR PRADESH
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
08779187963 |
| Fax |
|
| Email |
bhavesh.bandekar1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital Dr. E. Borges Marg, Parel, Mumbai – 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital DR E Borges marg Parel Mumbai 400012 |
| Type of Sponsor |
Other [Other [Government Hospital] ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Batra |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences ,Ansari Nagar ,New Delhi 110029
New Delhi
DELHI |
9013078407
batraatul85@gmail.com |
| Dr Alok K Goel |
Homi Bhabha Cancer Hospital & Research Center |
Homi Bhabha Cancer Hospital & Research Center, New Chandigarh
Chandigarh
CHANDIGARH |
9899701286
alokdrgoel@gmail.com |
| Dr Akhil kapoor |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC) Unit of Tata Memorial Centre Mumbai |
Department of Medical Oncology, OPD No. 28, DNT Block, Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi (U.P.) 221005 India
Varanasi
Varanasi
UTTAR PRADESH |
9950482121
kapoorakhil1987@gmail.com |
| Dr Vanita Noronha |
Tata Memorial Hospital |
OPD No 303, Homi Bhabha Block, Tata Memorial Hospital, Dr E Borges, Parel, Mumbai, Mahararashatra, Pin code 400012, India
Mumbai
MAHARASHTRA |
9769328047
vanita.noronha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics Commitee |
Approved |
| Institutional Ethics Commitee,Homi bhabha Cancer Hospital and Research Center,New Chandigarh |
Approved |
| Institutional Ethics Committee, MPMMCC and HBCH, Varanasi |
Approved |
| Institutional Ethics Committee-II, Tata Memorial Hospital |
Approved |
|
|
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 |
6 cycles of Docetaxel with Abiraterone 250 mg with low fat meal |
Patient will receive ADT + Docetaxel chemotherapy + 250 mg Abiraterone with low fat meal,followed by continuation of Abiraterone same dose till progression. |
| Intervention |
6 cycles of Docetaxel with Abiraterone 1000mg fasting.
|
Patient will receive Androgen deprivation therapy (ADT) + Docetaxel chemotherapy with Abiraterone 1000mg in fasting state, followed by continuation of Abiraterone same dose till progression. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
participants must be hormone sensitive prostrate cancer.
Age above 18 years
ECOG permance status <2
participants must have normal organ and marrow function |
|
| ExclusionCriteria |
| Details |
1.participants who are receiving any other investigational agents.
2.participants who are designated as unfit for receiving Abiraterone |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the non inferiority of low dose abiraterone 250mg with low fat meal compared to hogh dose abiraterone 1000mg with in fasting state to improve 3 year PSA PFS in patients with hormone sensitive metastatic prostate cancer receiving Androgen deprivation therapy+docetaxel chemotherapy |
3 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. OS
2.Toxicity
3.QOL |
3 years |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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 |
|
Date of First Enrollment (India)
|
08/03/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/03/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prostate cancer is the second most common malignancy worldwide. Abiraterone and Docetaxel are used in the metastatic prostate cancer to increase the overall survival. Both drugs have different mechanism and have ability to show more outcome in Hormone Sensitive Prostate Cancer when combined together. It is important to understand rationale use of drug since high dose may significant side effects. Thereby, we would like to compare low dose abiraterone with low fat meal versus full dose abiraterone when given in combination with docetaxel. |