Prospective Phase III Randomized Trial of Prostate Only or Whole Pelvic RadioTherapy in High Risk Prostate Cancer (POP-RT) Trial


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02302105

Sponsor: Tata Memorial Centre

Eligibility:

  • Age: minimum N/A maximum N/A
  • Gender: Male

Criteria: Inclusion 1. Any age according to the fitness estimated by the Physician 2. Physician estimated life expectancy > 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 - 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 5. Ability to receive long term hormone therapy/ Orchidectomy 6. KPS ≥ 70 (see appendix) 7. Estimated life expectancy > 5 years 8. No previous history of malignancy ≤5 years 9. No prior history of therapeutic irradiation to pelvis 10. Patient willing and reliable for follow-up and QOL 11. No major co morbidities preventing radical treatment 12. Signed study specific consent form Exclusion 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

View trial on ClinicalTrials.gov