A clinical trial to study the effects of radiotherapy on Prostate Only or whole Pelvic region in high risk prostate cancer patients. (POP-RT) trial
- Conditions
- Health Condition 1: null- prostate cancer
- Registration Number
- CTRI/2012/12/003181
- Lead Sponsor
- Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 224
Inclusion
1.Age 18 to 75 years
2Physician estimated life expectancy more than 5 years
3.Biopsy proven Adenocarcinoma of prostate
4.High risk prostate cancer based on Staging and Risk of Pelvic Nodal Metastases 20% as per the Roach formula
(2/3 PSA) + [(GS â?? 6) x 10]
4.If Gleason Score 8-10 with Any PSA, T1- T3a N0 M0
5. If Gleason Score 7 with PSA more than 15 T1-T3a N0 M0
6.If Gleason Score 6 with PSA more than 30 T1-T3a N0 M0
7. T3b-T4a N0 M0 Any Gleason Score Any PSA
8.Ability to receive long term hormone therapy/ orchidectomy
9.KPS moretha 70 (see appendix)
10.Estimated life expectancy more than 5 years
11.No previous history of malignancy
12.No prior history of therapeutic irradiation to pelvis
13.Patient willing and reliable for follow-up and QOL
14.No major co morbidities preventing radical treatment
15.Signed study specific consent form
1.Any histopathology other than Adenocarcinoma
2.Contraindication to Pelvic Radiotherapy like Inflammatory Bowel Disorders
3.No prior history of pelvic surgery
4.Uncontrolled diabetes
5.Uncontrolled cardiac co morbidity
6.Presence of nodal or distant metastatic disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o4 year Biochemical Failure Free (BFF) survivalTimepoint: o4 year Biochemical Failure Free (BFF) survival
- Secondary Outcome Measures
Name Time Method oDisease Free Survival (DFS) <br/ ><br>oOverall Survival <br/ ><br>oAcute Toxicity <br/ ><br>oLate toxicity <br/ ><br>oQOLTimepoint: 4 years