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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Dr Vedang Murthy

Navi Mumbai, Maharashtra, 410210, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IGRT

Radiation

Image Guided RT to the prostate

Primary outcomes

Biochemical Disease Free Survival

Time frame: 5 years

Biochemical failure is defined using the standard Phoenix consensus definition i.e. PSA>2ng/ml over the nadir PSA

Sponsors and collaborators

Lead sponsor

Tata Memorial Centre

Other

Registry information

Official study title

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

Acronym: POP-RT

Important dates

Study start: 2011
Primary completion: 2017
Study completion: 2026
First posted: Nov 26, 2014
Registry last updated: Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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