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

NCT02302105 | Active Not Recruiting DMC

• 1 other identifier: POP-RT
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Biochemical Disease Free Survival

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

  5 years

Study Arms (2)

Prostate Only

ACTIVE COMPARATOR

66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV

Radiation: IGRT

Whole Pelvis

EXPERIMENTAL

66-68 Gray (Gy) in 25 fractions will be prescribed for the prostate PTV and 50 Gy in 25 fractions to nodal region .

Radiation: IGRT

Interventions

IGRT RADIATION

Image Guided RT to the prostate

Prostate Only; Whole Pelvis

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Dr Vedang Murthy

Navi Mumbai, Maharashtra, 410210, India

Location

Related Publications (3)

• Maitre P, Maheshwari G, Sarkar J, Singh P, Kannan S, Dutta S, Phurailatpam R, Raveendran V, Prakash G, Menon S, Joshi A, Pal M, Arora A, Murthy V. Late Urinary Toxicity and Quality of Life With Pelvic Radiation Therapy for High-Risk Prostate Cancer: Dose-Effect Relations in the POP-RT Randomized Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2024 Oct 1;120(2):537-543. doi: 10.1016/j.ijrobp.2024.03.023. Epub 2024 Mar 28.

  PMID: 38552989 RESULT

• Murthy V, Maitre P, Kannan S, Panigrahi G, Krishnatry R, Bakshi G, Prakash G, Pal M, Menon S, Phurailatpam R, Mokal S, Chaurasiya D, Popat P, Sable N, Agarwal A, Rangarajan V, Joshi A, Noronha V, Prabhash K, Mahantshetty U. Prostate-Only Versus Whole-Pelvic Radiation Therapy in High-Risk and Very High-Risk Prostate Cancer (POP-RT): Outcomes From Phase III Randomized Controlled Trial. J Clin Oncol. 2021 Apr 10;39(11):1234-1242. doi: 10.1200/JCO.20.03282. Epub 2021 Jan 26.

  PMID: 33497252 RESULT

• Murthy V, Maitre P, Bhatia J, Kannan S, Krishnatry R, Prakash G, Bakshi G, Pal M, Menon S, Mahantshetty U. Late toxicity and quality of life with prostate only or whole pelvic radiation therapy in high risk prostate cancer (POP-RT): A randomised trial. Radiother Oncol. 2020 Apr;145:71-80. doi: 10.1016/j.radonc.2019.12.006. Epub 2020 Jan 7.

  PMID: 31923712 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Vedang Murthy

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: November 25, 2011
• Primary Completion: August 22, 2017
• Study Completion (Estimated): October 23, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

IN (1)