Status:
ACTIVE_NOT_RECRUITING
Randomized Trial of Prostate Only or Pelvic RT in High Risk Prostate Cancer
Lead Sponsor:
Tata Memorial Centre
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 25 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2026
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT02302105
Start Date
November 25 2011
End Date
October 23 2026
Last Update
February 13 2025
Active Locations (1)
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1
Dr Vedang Murthy
Navi Mumbai, Maharashtra, India, 410210