Rajiv Gandhi Cancer Institute and Research Centre, Room 3165, 1st floor, D Block, Sector-5 , Rohini, New Delhi – 110085, India New Delhi DELHI
9810241512
drvineettalwar@yahoo.com
Dr Atul Batra
AIIMS New Delhi
Room no - 160D, 1 floor, Dr. B.R Ambedkar Institute Rotary Cancer Hospital, Department of Medical Oncology, AIIMS New Delhi- 110029, India New Delhi DELHI
9013078407
batraatul85@gmail.com
Dr Ashish Singh
CMC Vellore
Christian Medical College, Vellore- 632004, Tamil Nadu, India Vellore TAMIL NADU
9445659460
ashishsingh@cmcvellore.ac.in
Dr Ashish Joshi
Mumbai Oncocare Centre
Mumbai Oncocare Centre (Unit of Cellcure Cancer Centre Pvt Ltd, 2nd Floor, Majithia Apartments, God’s Gift Premises Co-op. society Ltd, S V Road, Irla, Vile Parle (West), Mumbai, 400056. Mumbai MAHARASHTRA
9445659460
ashjoshi44@mocindia.co.in
Dr Anand Pathak
National Cancer Institute
Room 3165, 1st floor, D Block, National Cancer Institute, Khassara no 25, Outer Hinga ring Road, Mouza Jamtha, Nagpur- 441108, Maharashtra, India Mumbai MAHARASHTRA
9823038498
ethics@ncinagpur.in
Dr Arnab Bhattacharjee
TATA MEDICAL CENTRE - Kolkata
Tata Medical Center, 14 Major Arterial Road (EW), Newtown, Rajarhat, Kolkata – 700160 Kolkata WEST BENGAL
7980672007
arnab1572@gmail.com
Dr Akhil Kapoor
Tata memorial Centre, Varanasi
Department of Medical oncology at Tata memorial Centre (Homi Bhabha Hospital & Mahamana Pandit Madan Mohan Maviya Cancer Centre), Varanasi, India- 221005 Varanasi UTTAR PRADESH
9950482121
kapoorakhil1987@gmail.com
Dr Amit Joshi
Tata Memorial Hospital
11th floor, 1105, Tata memorial Hospital, Dept of Medical oncology, Dr. E. Borges Road, Parel, Mumbai- 400012, India. Mumbai MAHARASHTRA
9769331525
dramitjoshi74@gmail.com
Details of Ethics Committee
No of Ethics Committees= 8
Name of Committee
Approval Status
Ethics Committee, All India Institute of Medical Sciences, Room No 102, 1st Floor, Old O.T . Block, Ansari nagar, New Delhi, 110029
Submittted/Under Review
IEC, MPMMCC and HBCH Varanasi Mahamana Pandit Madan Mohan Malaviya Cancer Centre Sundar Bagiya, Near Nariya Gate Banaras Hindu University Campus Varanasi Varanasi Uttar Pradesh - 221005 India
Submittted/Under Review
Institutional Ethics Committee, National Cancer Institute, Nagpur- 441108
Submittted/Under Review
INSTITUTIONAL REVIEW BOARD CHRISTIAN MEDICAL COLLEGE THORAPADI POST BAGAYAM VELLORE Vellore Tamil Nadu - 632012 India
Submittted/Under Review
INSTITUTIONAL REVIEW BOARD TATA MEDICAL CENTER 14 MAJOR ARTERIAL ROAD EW RAJARHAT NEW TOWN Kolkata West Bengal - 700160 India
Submittted/Under Review
Institutional Review Board, Rajiv Gandhi Cancer Institute & Research Centre, sector 5 , Rohini, Delhi - 110085, India
Approved
Mumbai Oncocare Centre IEC Cellcure Cancer Centre Private Limited Majithira Apartment, God Gift Premises SV Road, Ville Parle West, Mumbai Mumbai Mumbai Suburban Maharashtra - 400056 India
Approved
The Chairman, TMH, Institutional Ethics Committee-I, Tata memorial Hospital, Dr.E Borges Road, Parel, Mumbai, Mumbai city, Maharasthtra- 400012 India
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: N428||Other specified disorders of prostate,
Intervention / Comparator Agent
Type
Name
Details
Intervention
NIL
NIL
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Male
Details
Patients diagnosed and/or treated with mCSPC or mCRPC 01 January 2023 onwards,
inclusive. mCSPC is defined as the current and/or historical presence of metastases
on any imaging modality sensitive to hormone therapy. mCRPC is defined as the
current and/or historical presence of metastases on any imaging modality with
evidence of disease progression (a rising PSA or radiographic progression (as defined
by the investigator) despite ongoing castration therapy [ADT or prior surgical
orchiectomy]).1,9
Aged at least 18 years upon diagnosis of mCSPC or mCRPC.
ExclusionCriteria
Details
Previously enrolled in an interventional trial related to metastatic prostate cancer.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Describe demographic and clinical characteristics at first diagnosis of metastatic
adenocarcinoma of prostate (mCSPC and mCRPC).
Document treatment patterns from original prostate cancer diagnosis in both mCSPC
and mCRPC.
Assess clinical outcomes among patients diagnosed with mCSPC and mCRPC,
including PSA response and real-world progression-free survival (PFS) in DDR
mutation/wild type, ORR, and OS.
Report mCRPC-specific HCRU.
Document time on treatment for each line of treatment for mCSPC and mCRPC.
Document time to next treatment from initiation of a systemic therapy line to the
commencement of the subsequent systemic therapy line for mCSPC and mCRPC.
Document time to subsequent chemotherapy from initiation of first-line systemic
treatment for mCSPC and mCSPC.
18 months
Secondary Outcome
Outcome
TimePoints
NA
NA
Target Sample Size
Total Sample Size="300" Sample Size from India="300" 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
N/A
Date of First Enrollment (India)
22/06/2024
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
Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Adenocarcinoma of the Prostate.
This is a multicentric, non-interventional, real-world observational study involving the review of pertinent data from medical records.
The study cohort will consist of all patients who meet the eligibility criteria. The date of metastatic prostate cancer diagnosis will define the study index date (T1), which must occur during the case selection window of 01 January 2023 onwards. The selection of these study dates is based on consideration of the anticipated data collection date, the need to document current treatment patterns (from the first-line metastatic setting), and allowance of at least 18-month follow-up opportunity for the assessment of study outcomes, particularly OS.
The time of metastatic prostate cancer diagnosis (T1) will represent the baseline. The baseline characteristics and treatment history prior to T1 will be assessed. The follow-up period will begin on the index date (T1). Patients will be followed until date of death or the date of last recorded medical visit. Patients who died before 18 months of follow-up and patients who have less than 18 months of follow-up as of their last recorded medical visit will be allowed into the study. All patient medical records that occur during follow-up will be reviewed and data on treatment regimens, treatment characteristics, clinical outcomes, and
resource use will be extracted. Consistent with the routine-care of mCSPC and mCRPC patients and differences in healthcare systems across the country (India), the follow-up visits are likely to be different.