| CTRI Number |
CTRI/2020/02/023447 [Registered on: 19/02/2020] Trial Registered Prospectively |
| Last Modified On: |
11/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study whether maintenance treatment with Abiraterone after docetaxel chemotherapy leads to further improvement in metastatic hormone sensitive prostate cancer. |
|
Scientific Title of Study
|
Sequential Abiraterone following Docetaxel Chemotherapy in Hormone Sensitive Metastatic Prostate Cancer |
| Trial Acronym |
SAD HORSE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project No 3082, Version 1.2 dated 18 june 2019 |
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 building, Tata Memorial Hospital
Dr.E.Borges Marg,
Parel, Mumbai
Mumbai
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 Hospital |
| Address |
1105, HBB building, Tata Memorial Hospital
Dr.E.Borges Marg,
Parel, Mumbai
Mumbai
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 Hospital |
| Address |
1105, HBB building, Tata Memorial Hospital
Dr.E.Borges Marg,
Parel, Mumbai
Mumbai
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 Hospital |
Room no 225, HBB building, 2nd floor,Tata Memorial Hospital
Dr. E. Borges Marg,
Parel, Mumbai – 400012
Mumbai
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, (2) ICD-10 Condition: N508||Other specified disorders of malegenital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abiraterone |
Arm B : Hormone therapy + Docetaxel chemotherapy followed by sequential Abiraterone. |
| Comparator Agent |
Observation |
Arm A : Hormone therapy + Docetaxel chemotherapy followed by Observation alone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Participants must be hormone sensitive prostate cancer for a histologically confirmed adenocarcinoma of prostate.
2. ECOG performance status ≤2.
3. Participants must have normal organ and marrow function.
|
|
| ExclusionCriteria |
| Details |
1. Participants who are receiving any other investigational agents.
2. Participants who are designated as unfit for receiving Abiraterone based chemotherapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
For Phase II:
PSA PFS: The interval between randomization and the date of documented progression or death before documented progression or treatment stopped due to any reason. Patients who have not progressed or died at their last follow ups would be censored.
For Phase III:
OS : OS will be defined as time period between date of randomization to date of death due to any cause. Patients alive at their last follow ups would be censored. |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Toxicity: To compare CTCAE version 4.03 worst grade toxicity between the 2 arms during any period of chemotherapy.
Overall Quality of Life: The Functional Assessment of Cancer Therapy-Prostate (FACIT-P) is a self report measure of both general and disease specific quality of life.
|
5 years |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/05/2020 |
| 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="5"
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
|
1.
Prostate
Cancer is the second most common malignancy worldwide. The
growth of prostate cancer is stimulated by male hormone (testosterone) i.e. Prostate Cancer is androgen dependent and can
be successfully treated with either surgical or medical castration. Androgen-deprivation
therapy in addition with Docetaxel is proved to be a standard of care for men
with metastatic, castration-sensitive Prostate Cancer. Previous studies
have proved that both Docetaxel and Abiraterone
have been used in metastatic Hormone sensitive prostate cancer. Both have
proved to increase the OS as well as the quality of life of patients. The
mechanism of action of both the agents is different. Barriers to the use of
Docetaxel include advanced patient age, poor performance status, coexisting
illnesses and patient preferences. The Objectives of the study includes to evaluate the ability of
sequential Abiraterone to improve PSA PFS and OS in patients with hormone
sensitive metastatic Prostate Cancer post hormone therapy + Docetaxel chemotherapy in Phase II and III respectively. It is a two arm, parallel design,
open label, sequential Phase 2/3 randomized controlled trial. In arm A, observation
would be done. The schedule of observation will be in accordance with the
institutional follow up protocol i.e patient would be followed up at 3 monthly
intervals. FACIT QOL Prostate would be filled at baseline, and 6 monthly
interval. In arm B, sequential Abiraterone would be administered. The patients
will be followed with CBC and biochemistry after one month. If patient
tolerates well, then patients will be followed after 2 months, then every 3
monthly. The patients would be followed up for two years after completing the
enrollment in phase II and three years in phase III part of study in both the
arms. The expected outcomes are improvement in PSA PFA and OS in Phase II and
III respectively.
|