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CTRI Number  CTRI/2020/03/024111 [Registered on: 20/03/2020] Trial Registered Prospectively
Last Modified On: 03/03/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study to Compare Quality of Life and side effects in patients undergoing Medical versus Surgical Castration in Metastatic Prostate cancer at Tata Memorial Hospital. 
Scientific Title of Study   A Prospective, Observational study to Compare Quality of Life and side effects in patients undergoing Medical versus Surgical Castration in Metastatic Carcinoma of Prostate at Tata Memorial Hospital. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Project No 3410  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Joshi  
Designation  Professor & Medical Oncologist 
Affiliation  Tata Memorial centre 
Address  1105, HBB building, Tata Memorial Hospital Dr.E.Borges Marg, Parel, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  022-24176755   
Fax    
Email  dramitjoshi74@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Joshi  
Designation  Professor & Medical Oncologist 
Affiliation  Tata Memorial centre 
Address  1105, HBB building, Tata Memorial Hospital Dr.E.Borges Marg, Parel, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  022-24176755   
Fax    
Email  dramitjoshi74@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Joshi  
Designation  Professor & Medical Oncologist 
Affiliation  Tata Memorial centre 
Address  1105, HBB building, Tata Memorial Hospital Dr.E.Borges Marg, Parel, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  022-24176755   
Fax    
Email  dramitjoshi74@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  Tata Memorial Hospital Dr. E. Borges Marg, Parel, Mumbai – 400012  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit Joshi  Tata Memorial centre   Room no 225, HBB building, 2nd floor,Tata Memorial Hospital Dr. E. Borges Marg, Parel, Mumbai – 400012
Mumbai (Suburban)
MAHARASHTRA 
022-24176229

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  
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 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  1) Patients with metastatic carcinoma prostate planned to receive either GnRH agonist / antagonist or surgical orchiectomy.

2)ECOG Criteria of 0,1,2.

3) Patient willing to undergo treatment and follow up at our centre.
 
 
ExclusionCriteria 
Details  1) Those not willing to comply with study procedures.

2) Patients with performance status of 3,4.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the quality of life between the patients undergoing medical and surgical castration.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the side effects between the patients undergoing medical and surgical castration.
2. To compare the expenditure of the treatments in the patients undergoing medical and surgical castration.
 
2 years 
 
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)   24/03/2020 
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 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  

Prostate cancer is one of the most common types of cancer in men. In case of Metastatic Prostate Cancer Patients, preferred option of treatment in the developed country is Medical Castration either by GnRH agonist or antagonist, but in case of India, majority of patients prefer undergoing surgical Orchiectomy taking into consideration the financial aspect of the patients in India.

Survival is an important endpoint in advanced Prostate Cancer, as is quality of life (QoL). The effects of the disease and its treatment on patient health-related QoL, plays an important role, when selecting the most appropriate treatment options. There are various side effects reported when it comes to patients undergoing surgical or medical castration as it causes sudden hormone changes in the body. Side effects from hormone changes may include sterility, loss of sexual interest, erection problems, hot flashes, weight gain, loss of muscle mass, osteoporosis, fatigue, heart disease, memory problems.

Objective of the study is to compare quality of life of patients undergoing Medical versus Surgical Castration, at every 3 months till 2 year using FACT-P Questionnaire and to assess the side-effects and financial aspect of the patients in both the arms.

Patients with histologically proven metastatic prostate cancer, attending the OPDs of Uro-oncology DMG at Tata Memorial Hospital and willing to take treatment will be screened for the study. Informed consent form will be administered to the patient and patient will be explained about the study in detail. Patient will be enrolled in the study after he signs the informed consent form.

Patient after making the choice regarding the treatment options i.e. medical or surgical castration will be followed up during their regular OPD visits i.e. 3 monthly ±3 weeks for a period of 2 years and will be asked to fill a questionnaire FACT-P as per choice of their language, as FACT-P questionnaire is validated for English, Hindi, Marathi languages.


NOTE: 

Since it is a non-randomized study, patient will receive treatment as per their choice. So, for the sake of assessment of toxicity, patients will be enrolled in each arm on time basis, i.e. number of metastatic prostate cancer patients coming in Uro-Oncology DMG in 2 years will be enrolled (i.e. Approximately 300 in 2 years) and will be followed up for 2 years, who will agree to undergo treatment and follow up at our centre.

 
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