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CTRI Number  CTRI/2025/07/090975 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 24/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [Personalized Treatment for Advanced Prostate Cancer Based on Molecular Risk]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Personalized Treatment for Advanced Prostate Cancer Using Genetic Risk (MAP-PROSTATE Study) 
Scientific Title of Study   Molecular risk adapted treatment modification in patients with metastatic hormone sensitive prostate cancer. (MAP-PROSTATE). 
Trial Acronym  Prostate Cancer 
Secondary IDs if Any  
Secondary ID  Identifier 
4770_Protocol_Version_1.0_dated_16.08.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Minit Shah 
Designation  Associate Professor, Medical Oncology 
Affiliation  Tata Memorial Hospital 
Address  Room No 1006,10 floor, Homi bhabha Block,Tata Memorial hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9892640668  
Fax    
Email  minitjshah@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Minit Shah 
Designation  Associate Professor, Medical Oncology 
Affiliation  Tata Memorial Hospital 
Address  Room No 1006,10 floor, Homi bhabha Block,Tata Memorial hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9892640668  
Fax    
Email  minitjshah@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Minit Shah 
Designation  Associate Professor, Medical Oncology 
Affiliation  Tata Memorial Hospital 
Address  Room No 1006,10 floor, Homi bhabha Block,Tata Memorial hospital, Dr. E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9892640668  
Fax    
Email  minitjshah@gmail.com  
 
Source of Monetary or Material Support  
Will be applying for Extramural funding. 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atul Batra  All India Institute of Medical Sciences   Room no. 160D, 1st floor, Department of Medical Oncology, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, Ansari Nagar, New Delhi 110029
New Delhi
DELHI 		 9013078407

batraatul85@gmail.com 
Dr Akhil Kapoor  Mahamana Pandit Madan Mohan Malaviya Cancer Centre  Department of Medical Oncology, OPD No. 28, Ground floor, DNT Block, Sundar Bagiya, Near Nariya Gate, Banaras Hindu University Campus, Varanasi (U.P.) 221005 India
Varanasi
UTTAR PRADESH 		 7597364554

kapoorakhil1987@gmail.com 
Dr Minit Shah  Tata Memorial Hospital  Seconf Floor, Homi Bhabha Block Building, Tata Memorial Hospital, Dr.E.Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA 		 9987871787

minitjshah@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences  Approved 
Ethics Commitee II  Approved 
Institutional Ethics Committee Varanasi  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 
Intervention  Cohort A- Docetaxel,Cabazitaxel,Carboplatin,Cisplatin  Docetaxel will be administered as per the standard institutional practice (50 mg/m2 2-weekly for up to 9 cycles, or 75 mg/m2 3-weekly for up to 6 cycles). Dose modifications will be allowed as per the PI discretion Cabazitaxel will be administered as per standard institutional practice, 20mg/m2 or 25mg/m2 as an IV infusion in 250mL Sodium Chloride 0.9% over 60 mins, every 3-weekly (PVC free). Carboplatin AUC 4 or 5 (calculated by Calvert formula) will be administered intravenous, in 250-500ml 0.9%NS or dextrose solutions over 30-60mins every 3-weekly (if planned) Cisplatin will be dosed at 75 mg/m2on day 1 of each cycle, diluted in 500ml of 0.9% normal saline (with appropriate pre- and post-chemotherapy hydration, and anti-emetic measures).  
Intervention  Cohort B- Tablet Abiraterone,Capsule Enzalutamide ,Tablet Apalutamide   Tablet Abiraterone 1000mg (250mg x 4, or 500mg x 2, fasting, 1 hour before or 2 hours after breakfast) or 250mg (with low-fat meal) will be self-administered once daily. Tablet prednisolone 5mg will be self-administered once daily continuously. The combination will be continued till prohibitive toxicity or disease progression. One cycle will constitute one month of continuous administration. Capsule Enzalutamide 160mg (40mg x 4) will be administered once a day, may be taken with or without food. Do not chew, dissolve, or open the capsules. Liquid formulations will be permitted, 160mg in 5ml standard formulation, once a day, with or without food. Capsule/liquid formulation will be continued till prohibitive toxicity or disease progression. One cycle will constitute one month of continuous administration. Tablet Apalutamide 240mg (60mg x 4) will be administered once a day, may be taken with or without food. Do not chew, dissolve, or break the tablets. Tablet will be continued till prohibitive toxicity or disease progression. One cycle will constitute one month of continuous administration.  
Intervention  Cohort C- Tablet Abiraterone or Capsule Enzalutamide,Tablet Olaparib,Tablet Talazoparib   Tablet Abiraterone 1000mg (250mg x 4, or 500mg x 2, fasting, 1 hour before or 2 hours after breakfast) or 250mg (with low-fat meal) will be self-administered once daily. Tablet prednisolone 5mg will be self-administered once daily continuously. The combination will be continued till prohibitive toxicity or disease progression. One cycle will constitute one month of continuous administration. Capsule Enzalutamide 160mg (40mg x 4) will be administered once a day, may be taken with or without food. Do not chew, dissolve, or open the capsules. Liquid formulations will be permitted, 160mg in 5ml standard formulation, once a day, with or without food. Capsule/liquid formulation will be continued till prohibitive toxicity or disease progression. One cycle will constitute one month of continuous administration. Tablet Olaparib 300mg (150mg x 2) will be administered twice a day, may be taken with or without food. Do not chew, dissolve, or break the tablets. Tablet will be continued till prohibitive toxicity or disease progression. One cycle will constitute one month of continuous administration. Tablet Talazoparib 0.5mg will be administered once a day, may be taken with or without food. Do not chew, dissolve, or break the tablets. If the patient vomits or misses a dose, the next prescribed dose has to be taken at the usual time.  
Comparator Agent  Docetaxel,Tablet Abiraterone,Tablet Darolutamide   Docetaxel will be administered as per the standard institutional practice (50 mg/m2 2-weekly for upto 9 cycles, or 75 mg/m2 3-weekly for upto 6 cycles). Dose modifications will be allowed as per the PI discretion Tablet Abiraterone 1000mg (250mg x 4, or 500mg x 2, fasting, 1 hour before or 2 hours after breakfast) or 250mg (with low-fat meal) will be self-administered once daily. Tablet prednisolone 5mg will be self-administered once daily continuously. The combination will be continued till prohibitive toxicity or disease progression. One cycle will constitute one month of continuous administration. Tablet Darolutamide 600mg (300mg x 2) will be self-administered twice a day along with food. Do not chew, dissolve, or break the tablets. Tablet will be continued till prohibitive toxicity or disease progression. One cycle will constitute one month of continuous administration.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  1. Histologically confirmed,De novo or recurrent patients with metastatic hormone sensitive prostate cancer
2. Completed 18 years of age
3. ECOG-PS 0-2
4. with adequate organ functions
5. controlled co-morbidities
6. willing to comply and consent to the study. 
 
ExclusionCriteria 
Details  1. Participants who are receiving any other investigational agents.
2. History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to any agents used in study.
3. Patients unfit for docetaxel or abiraterone or enzalutamide or apalutamide or PARPi based therapy.
4. Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease, known hyperkalaem.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare non-inferiority of treatment in Arm-A (biomarker driven treatment allocation), to treatment in Arm-B (biomarker blind, standard triplet therapy) to improve 3-year Overall Survival (OS) in patients with de-novo or recurrent metastatic hormone sensitive prostate cancer  3 years 
 
Secondary Outcome  
Outcome  TimePoints 
1.PSA less than 0.2ng/ml at 7 months of treatment initiation.
2.To evaluate radiological progression free survival (rPFS).
3.To evaluate PSA progression free survival (PSA-PFS).
4.To compare the best overall response rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
5.To assess and compare safety and tolerability.
6.To compare the quality of life (QOL).
7.To evaluate time to pain progression.
8.To evaluate time-to-first symptomatic skeletal event (SSE).
9.To evaluate SSE-Free Survival (SSE-FS).
 		 3 years 
 
Target Sample Size   Total Sample Size="314"
Sample Size from India="314" 
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)   01/08/2025 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Prostate cancer is the second most common malignancy worldwide. In India, it accounts for 6.1% of all cancers diagnosed in men. The estimated incidence in 2020 was 41,532 new cases (per year), however, it is estimated to reach close to fifty-thousand new cases by 2025. At our institute we see approximately 300 to 400 new cases of metastatic hormone sensitive prostate cancer (mHSPC) per year, therefore, the burden of prostate cancer cases in India is high. Since the initial observation by Huggins and Hodges in 1941 that prostate cancer is androgen dependent and can be successfully treated with either surgical or medical castration, hormonal therapy has been the mainstay of treatment for men with newly diagnosed metastatic prostate cancer. Castration-resistant prostate cancer develops in the majority of men within 1–3 years, with the result that median survival among patients with metastatic prostate cancer is ~ 3–4 years. Efforts at improving overall survival in the metastatic setting have, until recently, been directed towards patients with metastatic castrate-resistant prostate cancer (mCRPC) with significant improvements seen during the past decade. This is evidenced by the ability of six agents to increase overall survival in mCRPC. This includes the androgen biosynthesis inhibitor abiraterone acetate, the androgen receptor inhibitor, enzalutamide, immunotherapy with sipulecel-T, cabazitaxel and docetaxel chemotherapy and the radioisotope radium-223. However, each agent increases overall survival by a few months at best and despite these advances, metastatic prostate cancer remains a lethal disease. 
In this study, we propose the utilization of baseline tumour NGS testing to identify patients with chemotherapy-sensitive, hormone-sensitive, or PARPi-sensitive disease, to enable effective modification/de-escalation of standard first-line triplet therapy without compromising survival outcomes. Treatment modification or de-escalation will safeguard potent second-line drugs for treatment of progressive disease.
 
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