NCT02302105

Randomized Trial of Prostate Only or Pelvic RT in High Risk Prostate Cancer

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Tata Memorial Centre · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	IGRT	Image Guided RT to the prostate

Timeline

• Start date: 2011-11-25
• Primary completion: 2017-08-22
• Completion: 2026-10-23
• First posted: 2014-11-26
• Last updated: 2025-02-13

Locations

1 site across 1 country: India