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
|
|
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
|
|
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. |