| CTRI Number |
CTRI/2020/07/026761 [Registered on: 24/07/2020] Trial Registered Prospectively |
| Last Modified On: |
07/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Other |
|
Public Title of Study
|
Rectal spacer for Prostate Cancer Radiotherapy |
|
Scientific Title of Study
|
A pilot study for standardizing use of rectal spacer for Prostate Cancer Radiotherapy |
| Trial Acronym |
na |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRahul Krishnatry |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology,HBB 1125, Tata Memorial hospital, parel Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRahul Krishnatry |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology,HBB 1125, Tata Memorial hospital, parel Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRahul Krishnatry |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Radiation Oncology,HBB 1125, Tata Memorial hospital, parel Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre
Dr Earnest Bordges Road, Parel, Mumbai |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre Department of Atomic Energy Clinical Trial Centre |
| Address |
Dr.E.Borges Marg,Parel, Mumbai-400012, India |
| 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 Rahul Krishnatry |
Tata Memorial Centre |
Department Of Radiation Oncology, Urology. Dr. E. Borges Marg, Parel Mumbai-400012
Mumbai (Suburban)
MAHARASHTRA |
02224177028
krishnatry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-II |
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 |
| Intervention |
insertion of rectal seperator for prostate radiotherapy |
Either blood or hyaluronic acid will be inserted as spacer under local anaesthesia prior to ratiotherapy for prostate cancer patients to reduce the dose to rectum and hence late rectal toxicity. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
1.Age above 18 years
2.Histologically proven adenocarcinoma prostate
3.Any patient suitable and considered for local radical radiotherapy treatment for prostate cancer.
4.No prior pelvic radiotherapy or proctocolitis or inflammatory bowel disease.
5.No contra-indication for prostate radiotherapy.
6.Informed Consent signed for the procedure.
7.Participant in any other clinical trial is not an exclusion criterion.
|
|
| ExclusionCriteria |
| Details |
1.Unreliable to follow up or poor logistic or social support
2.Involvement of rectal wall on diagnostic MRI scan (standard investigation).
3.Allergic to lignocaine or other local anaesthetic agents.
4.Too anxious to undergo the procedure under local anaesthesia.
5.No bleeding disorder and normal INR, platelet counts, Clotting time, bleeding time
6.Patients on any blood thinners/anticoagulation therapy for systemic conditions which alters platelet count/PTT/INR beyond normal range.
7.MRI is contraindicated for any reason.
8.Not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop standard procedures for recto-prostatic spacer during prostate cancer radiotherapy treatment using blood or hyaluronic acid. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional success in creating 5 – 10 mm space between rectal wall and prostate (at mid gland level)
To assess procedure related Adverse Events (AEs)
To study the impact on dose to the rectum with and without recto-prostatic spacer (blood or hyaluronic acid) when planning radical radiotherapy for prostate cancer.
|
2 years |
To evaluate the impact of recto-prostatic spacer on doses to the target coverage and other organs at risk like bladder, femoral heads and bowel.
Stability of space created and identification of space, during the course of radiotherapy.
To assess early (at radiotherapy conclusion and 3 months) and late rectal toxicity (at 6, 12, 18 and 24 months) as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
|
2 years |
To see if CT and CBCT is as good as MRI to identify volume and dimensions of recto-prostatic space created using blood or hyaluronic acid.
Cost analysis for using two types of spacers (blood and hyaluronic acid).
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
31/07/2020 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Suspended |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Radiotherapy is one of the established treatments for prostate cancer. Modern radiotherapy techniques have been helpful in decreasing dose to adjacent normal structures like bladder and rectum when prostate is being irradiated. However, some significant dose is still received by these organs which can lead to late side effects. Recently, some inert or body similar materials have been used to create space between rectum and prostate and have gained standard of care status through randomized trials for ability to decrease rectal toxicity. These materials are not available off label in India. In this study we are trying to standardize the workflow and testing two of the such materials. One is Hyaluronic acid which is easily available and other is patient’s own blood which can be very cost effective for our patient population. These will help in decreasing the side effects as well as guide more economical solution for Indian patient population. |