| CTRI Number |
CTRI/2019/09/021080 [Registered on: 05/09/2019] Trial Registered Prospectively |
| Last Modified On: |
04/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to capture the side effects and Quality of life(QoL) in castration-resistant prostate cancer patients who are receiving docetaxel as part of standard therapy in Tata Memorial Centre. |
|
Scientific Title of Study
|
A prospective study to evaluate the Adverse Drug Reactions and to assess quality of life in prostate cancer patients receiving docetaxel in Tata Memorial Centre. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No 3293, Version 1 Dated 28.11.2018 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Joshi |
| Designation |
Professor & Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
1105 HBB Dr E Borges Road Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769331525 |
| Fax |
|
| Email |
dramitjoshi74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Joshi |
| Designation |
Professor & Medical Oncologist |
| Affiliation |
Tata Memorial Hospital |
| Address |
1105 HBB Dr E Borges Road Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769331525 |
| Fax |
|
| Email |
dramitjoshi74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath Nookala |
| Designation |
SCIENTIFIC OFFICER E |
| Affiliation |
Tata Memorial Centre ACTREC |
| Address |
ACTREC Sector 22 Utsav Chowk CISF Road, Owe Camp Kharghar Navi Mumbai Maharashtra
Mumbai
MAHARASHTRA
410210
India |
| Phone |
|
| Fax |
|
| Email |
nk.manjunath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Dr. E. Borges Road, Parel, Mumbai -400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Joshi |
ACTREC |
Sector 22 Kharghar Navi Mumbai 410210
Mumbai
MAHARASHTRA |
02227405000
dramitjoshi74@gmail.com |
| Dr Amit Joshi |
Tata Memorial Hospital |
OPD HBB 225 And GJB 59 Department of Uro Medical Oncology Tata Memorial hospital Dr E Borges Road Parel Mumbai 400012 (Extn 6229)
Mumbai
MAHARASHTRA |
02224177000
dramitjoshi74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Male |
| Details |
1. Patient of either gender aged 18 or more than 18
2. Metastatic Prostate Carcinoma patients receiving docetaxel chemotherapy. |
|
| ExclusionCriteria |
| Details |
1. Patient not willing to give consent.
2. Patients having non-compliance to the treatment schedule at Tata memorial Hospital or ACTREC. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adverse Drug Reaction |
2 Weekly- 3 Weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grade III and Grade IV adverse events |
2 Weekly- 3 Weekly |
| Causality assessment of the adverse reactions |
2 Weekly- 3 Weekly |
| quality of life |
2-3 Monthly |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
19/09/2019 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cancer is a dreaded disease and can compromise the life of the patient. They are treated with anti-cancer drug s which can cause many adverse drug reactions (ADRs) along with the beneficial effect, which can compromise their quality of life. As a standard treatment practice, castration-resistant prostate cancer patients are treated with Docetaxel as either 2 weekly or 3 weekly regimen depending on the clinical decision. We would like to conduct a study to systematically capture the adverse events experienced by the castration-resistant prostate cancer patients who are receiving docetaxel. We will be regularly following the patients as long as they are on treatment with docetaxel, which could be till the progression of disease, death or patient lost to follow up (which-ever is earlier). In addition to ADRs we will also be capturing the quality of life (QoL) data of patients who are taking docetaxel using validated EORTC QOL C-30 and EORTC QOL PR-25 Questionnaires. This QoL data will be obtained every 2 to 3 months (depending on the clinical condition of the patient) as long as the patient is on docetaxel which could be till the progression of the disease, death or patient lost to follow up (which-ever is earlier). |