| CTRI Number |
CTRI/2018/05/014054 [Registered on: 22/05/2018] Trial Registered Prospectively |
| Last Modified On: |
28/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Prostate Radiotherapy In high risk and node positive disease comparing Moderate & Extreme hypofractionation. |
|
Scientific Title of Study
|
Randomised controlled trial of Prostate Radiotherapy In high risk & node positive disease comparing Moderate & Extreme hypofractionation. |
| Trial Acronym |
PRIME |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vedang Murthy |
| Designation |
Professor,Dept of Radiation Oncology |
| Affiliation |
TMH/ ACTREC |
| Address |
OPD 223, Homi Bhabha Block, Tata Memorial Hospital, Dr E. Borges marg, Parel Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224176227 |
| Fax |
|
| Email |
vedangmurthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vedang Murthy |
| Designation |
Professor,Dept of Radiation Oncology |
| Affiliation |
TMH/ ACTREC |
| Address |
OPD 223, Homi Bhabha Block, Tata Memorial Hospital, Dr E. Borges marg, Parel Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224176227 |
| Fax |
|
| Email |
vedangmurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vedang Murthy |
| Designation |
Professor,Dept of Radiation Oncology |
| Affiliation |
TMH/ ACTREC |
| Address |
OPD 223, Homi Bhabha Block, Tata Memorial Hospital, Dr E. Borges marg, Parel Mumbai 400012
Mumbai (Suburban)
MAHARASHTRA
400012
India
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
02224176227 |
| Fax |
|
| Email |
vedangmurthy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
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
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Indranil Mallick |
Tata Medical Centre |
Dept of
radiation Oncology 14
Major Arterial Road(EW)
New Town, Rajarhat,
Kolkata 700160
Kolkata
WEST BENGAL |
9831171235
imallick@gmail.com |
| Dr Vedang Murthy |
Tata Memorial Centre |
OPD 223, Dept of Radiation Oncology, Urology, Dr E Borges Marg, Parel Mumbai
Mumbai (Suburban)
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
02224176227
vedangmurthy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Tata Medical Centre-Institutional Review Board |
Approved |
| TMH-ACTREC IEC-III |
Approved |
| TMH-ACTREC IEC-III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
1.Participants must be histologically proven, adenocarcinoma prostate.
2. Localised to prostate or pelvic lymph nodes., (1) ICD-10 Condition: N428||Other specified disorders of prostate, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Extreme hypofractionated RT(Test arm) |
Patients in this arm will receive a course of 5 fractions of radiation; each fraction size will be 7.25 Gy. The total dose will be 36.25 Gy. All patients irrespective of nodal status will receive a dose of 25Gy in 5 # to the pelvic nodes. The 5 treatments will be scheduled to be delivered alternate day over 7-10 days.An option of equivalent biological dose using 35-36.25 Gy in 5 weekly fractions may be allowed for multicentric accrual in the future. |
| Comparator Agent |
Moderately hypofractioated RT(Standard arm) |
Patients in this arm will receive a total dose of 68Gy in 25# to the primary over 5 weeks, with treatment being delivered daily. All patients irrespective of nodal status will receive a dose of 50Gy in 25# to the pelvic nodes.Boost to gross nodal disease will be considered based on the response to hormonal therapy to a dose of 60-66Gy/25# as a simultaneous integrated boost (SIB). An option of equivalent biological dose using 60-62.5 Gy in 20# may be allowed for multi-centric accrual in the future. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
1. Participants must be histologically proven, adenocarcinoma prostate
2. Localised to the prostate or pelvic lymph nodes
3. High risk prostate cancer as per NCCN definition
clinical stage T3a or Gleason score 8/Gleason grade group4 or Gleason score 9-10/gleason grade group 5, PSA > 20 ng/mL.orVery high risk prostate cancer i.e T3b-T4 or Primary Gleason pattern 5/Gleason grade group 5 or > 4cores Gleason score8-10/Gleason grade group 4 or5
4. Ability to receive long term hormone therapy/ orchidectomy
5. KPS >70
6. No prior history of therapeutic irradiation to pelvis
7. Patient willing and reliable for follow-up and QOL
8. Signed study specific consent form
|
|
| ExclusionCriteria |
| Details |
1.Evidence of distant metastasis at anytime since presentation.
2. Life expectancy<2 year.
3. Previous RT to prostate or prostatectomy.
4. A previous trans-urethral resection of the Prostate(TURP).
5. Severe urinary symptoms or with severe IPSS score (>15) inspite of being on hormonal therapy for 6months which in the opinion of the physician precludes RT.
6. Patients with known obstructive symptoms with stricture.
7. Any containdication to radiotherapy like inflammatory bowel disease.
8. Uncontrolled co-morbidities including, but not limited to diabetes or hypertension.
9. Unable to follow up or poor logistic or social support. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the 4 year Biochemical Failure free Survival (BFFS) between the two arms.. |
Four years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate acute and late toxicity with both treatments.
2. To find the Prostate cancer specific survival and overall survival of patients receiving moderately hypofractionated RT and SBRT.
3. To estimate the out of pocket expenditure involved in patients receiving the two treatment schedules.
4. To assess quality of life
|
• All patients will follow up 3-6 weeks from end of radiotherapy, followed by 3-6 monthly for the first two years depending on the clinical need and 6 monthly thereafter.
• QOL will be assessed at baseline and 6 monthly using the QLQC30 and PR25 EORTC Questionnaire.
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="464"
Sample Size from India="464"
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 3 |
|
Date of First Enrollment (India)
|
31/05/2018 |
| 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="12"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
No publications as of now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The aim of the study is to compare the efficacy with SBRT and moderate hypo-fractionation in high risk and node positive prostate cancer.
Study Design and Randomization. Patients will be randomized to one of the below mentioned arms using stratified block randomization method.
Arm 1 (Standard arm): Moderate hypo-fractionated RT 66-68 Gy/25# Arm 2 (Test arm): Extreme hypo-fractionated RT with SBRT 35-37.5 Gy/5#
Stratification : Stratification will be done for the following parameters. 1. Nodal status: N0 Vs N+ 2. Medical castration vs Surgical castration 3.Centre: TMC Mumbai Vs TMC Kolkata |