Randomized Trial of Prostate Only or Pelvic RT in High Risk Prostate Cancer (POP-RT)
Primary Purpose
Prostate Cancer
Status
Active
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
IGRT
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion
- Any age according to the fitness estimated by the Physician
- Physician estimated life expectancy > 5 years
- Biopsy proven Adenocarcinoma of prostate
- High risk prostate cancer based on Staging and Risk of Pelvic Nodal Metastases ≥ 20% as per the Roach formula (2/3 PSA) + [(GS - 6) x 10] If Gleason Score 8-10 - Any PSA, T1- T3a N0 M0 If Gleason Score 7 - PSA > 15, T1-T3a N0 M0 If Gleason Score 6 - PSA > 30, T1-T3a N0 M0 T3b-T4a N0 M0, Any Gleason Score, Any PSA
- Ability to receive long term hormone therapy/ Orchidectomy
- KPS ≥ 70 (see appendix)
- Estimated life expectancy > 5 years
- No previous history of malignancy ≤5 years
- No prior history of therapeutic irradiation to pelvis
- Patient willing and reliable for follow-up and QOL
- No major co morbidities preventing radical treatment
- Signed study specific consent form
Exclusion
- Any histopathology other than Adenocarcinoma
- Contraindication to Pelvic Radiotherapy like Inflammatory Bowel Disorders
- No prior history of pelvic surgery
- Uncontrolled diabetes
- Uncontrolled cardiac co morbidity
- Presence of nodal or distant metastatic disease
Sites / Locations
- Dr Vedang Murthy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Prostate Only
Whole Pelvis
Arm Description
66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV
66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV and 50 Gy in 25 fractions to nodal region .
Outcomes
Primary Outcome Measures
Biochemical Disease Free Survival
Biochemical failure is defined using the standard Phoenix consensus definition i.e. PSA>2ng/ml over the nadir PSA
Secondary Outcome Measures
Full Information
NCT ID
NCT02302105
First Posted
November 24, 2014
Last Updated
November 20, 2021
Sponsor
Tata Memorial Centre
1. Study Identification
Unique Protocol Identification Number
NCT02302105
Brief Title
Randomized Trial of Prostate Only or Pelvic RT in High Risk Prostate Cancer
Acronym
POP-RT
Official Title
Prospective Phase III Randomized Trial of Prostate Only or Whole Pelvic RadioTherapy in High Risk Prostate Cancer (POP-RT) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 25, 2011 (Actual)
Primary Completion Date
October 23, 2025 (Anticipated)
Study Completion Date
October 23, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Memorial Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evidence to justify the use of the pelvic field is lacking for men with high risk localized prostate cancer. An additional randomized study is needed in men with a potential risk of nodal involvement to test the hypothesis that the use of the pelvic field contributed to the benefit observed in those studies.
This trial aims to compare the outcomes with whole pelvis RT and Prostate alone RT in patients with High risk, non metastatic Prostate cancer with a Lymph nodal >20% with Primary 5 year Biochemical failure free survival and Secondary Disease free survival, overall survival, Acute toxicity, Late toxicity and QOL Patients will be randomized to one of two arms Arm 1 Whole pelvis radiotherapy and Arm 2 Prostate only radiotherapy. The Dose prescription will be 66 Gy in 25 fractions will be prescribed for the prostate PTV in Arm 2 an additional 50 Gy in 25 fractions for nodal PTV in patients in Arm 1. An overlap volume at rectal-prostate interface will receive 64 Gy/25#.
All patients will receive hormone therapy starting at least 8 weeks prior to the beginning of radiotherapy. They will continue the hormone therapy and later for a total duration of 2-3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prostate Only
Arm Type
Active Comparator
Arm Description
66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV
Arm Title
Whole Pelvis
Arm Type
Experimental
Arm Description
66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV and 50 Gy in 25 fractions to nodal region .
Intervention Type
Radiation
Intervention Name(s)
IGRT
Intervention Description
Image Guided RT to the prostate
Primary Outcome Measure Information:
Title
Biochemical Disease Free Survival
Description
Biochemical failure is defined using the standard Phoenix consensus definition i.e. PSA>2ng/ml over the nadir PSA
Time Frame
5 years
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion
Any age according to the fitness estimated by the Physician
Physician estimated life expectancy > 5 years
Biopsy proven Adenocarcinoma of prostate
High risk prostate cancer based on Staging and Risk of Pelvic Nodal Metastases ≥ 20% as per the Roach formula (2/3 PSA) + [(GS - 6) x 10] If Gleason Score 8-10 - Any PSA, T1- T3a N0 M0 If Gleason Score 7 - PSA > 15, T1-T3a N0 M0 If Gleason Score 6 - PSA > 30, T1-T3a N0 M0 T3b-T4a N0 M0, Any Gleason Score, Any PSA
Ability to receive long term hormone therapy/ Orchidectomy
KPS ≥ 70 (see appendix)
Estimated life expectancy > 5 years
No previous history of malignancy ≤5 years
No prior history of therapeutic irradiation to pelvis
Patient willing and reliable for follow-up and QOL
No major co morbidities preventing radical treatment
Signed study specific consent form
Exclusion
Any histopathology other than Adenocarcinoma
Contraindication to Pelvic Radiotherapy like Inflammatory Bowel Disorders
No prior history of pelvic surgery
Uncontrolled diabetes
Uncontrolled cardiac co morbidity
Presence of nodal or distant metastatic disease
Facility Information:
Facility Name
Dr Vedang Murthy
City
Navi-Mumbai
State/Province
Maharashtra
ZIP/Postal Code
410210
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
31923712
Citation
Murthy V, Maitre P, Bhatia J, Kannan S, Krishnatry R, Prakash G, Bakshi G, Pal M, Menon S, Mahantshetty U. Late toxicity and quality of life with prostate only or whole pelvic radiation therapy in high risk prostate cancer (POP-RT): A randomised trial. Radiother Oncol. 2020 Apr;145:71-80. doi: 10.1016/j.radonc.2019.12.006. Epub 2020 Jan 7.
Results Reference
derived
Learn more about this trial
Randomized Trial of Prostate Only or Pelvic RT in High Risk Prostate Cancer
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