Trial Comparing Radical Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer

Phase II Randomized Control Trial Comparing Radical Hypofractionated Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer

This phase II randomized controlled study aims to compare the treatment results of intermediate and high risk prostate cancer patients treated with hormonal therapy and radical radiotherapy with or without pelvic lymph nodes in NCI- Cairo University.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Prostate Only Radiation; Radiation: Prostate and Pelvic Lymph Node Radiation

Detailed Description

Study Design :

Phase II prospective randomized trial with 2 arms • Prostate Only (Arm A)

Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to dose of 60Gy/20fractions (3 Gy per fraction)

• Prostate & Pelvic Lymph Nodes (Arm B)

Hypofractionated Intensity modulated radiotherapy (IMRT) with elective pelvic nodes irradiation up to 44Gy/20 fractions (2.2 Gy per fraction) with a Simultaneous Integrated Boost (SIB) to the prostate to dose of 60Gy/20fractions (3 Gy per fraction)

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ahmed Abdelhamid, Msc; Phone Number: +201203262526; Email: ahmed.abdelhamid@nci.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • National Cancer Institute - Cairo University
    • Contact: Ahmed Abdelhamid; Phone Number: +201203262526; Email: ahmed.abdelhamid@nci.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Histologically-proven prostatic adenocarcinoma.

• Risk stratification from intermediate to very high risk will be included according to NCCN guide lines September 5, 2019 version 4.2019:

  • Intermediate risk: T2b or T2c and/or GS =7 and/or PSA >10-20. Both the favorable intermediate (1 intermediate risk factor (IRF) and Grade Group 1 or 2 and <50% biopsy core positive) and unfavorable intermediate risk (2 or 3 IRFs and/or Grade Group 3 and/or ≥50% biopsy cores positive) will be included.
  • High risk: T3a or PSA >20 or Grade Group 4 or 5, not very high risk.
  • Very high risk: T3b-4, primary gleason pattern 5 OR >4 cores with grade group 4 or 5
• N stage: N0
• M Stage: M0
• Performance Status: PS 0-2

Exclusion Criteria:

• Low risk prostate cancer
• Histologies other than adenocarcinoma
• Patients with significant comorbidities might affect treatment completion and follow up
• Previously received pelvic radiotherapy
• Patients with metastatic disease
• Poor performance status (PS ≥ 3)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prostate Only (Arm A); Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to a dose of 60Gy/20fractions (3 Gy per fraction)	Radiation: Prostate Only Radiation; Prostate Only Radiation for Intermediate and High Risk Prostate cancer
Experimental: Prostate and Pelvic Lymph Nodes (Arm B); Hypofractionated Intensity modulated radiotherapy (IMRT) with elective pelvic nodes irradiation up to 44Gy/20 fractions (2.2 Gy per fraction) with a Simultaneous Integrated Boost (SIB) to the prostate to a dose of 60Gy/20fractions (3 Gy per fraction)	Radiation: Prostate and Pelvic Lymph Node Radiation; Prostate and Pelvic Lymph Node Radiation for Intermediate and High Risk Prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute toxicity	Compare Acute toxicity between the 2 arms using Radiation Therapy Oncology Group (RTOG) acute morbidity scoring criteria.	90 days post the end of radiation therapy
Local Control	Compare Local control (LC) with minimum follow up of 1 year in both groups	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical free survivals (BFS)	Biochemical free survivals (BFS) with minimum follow up of 1 year in both groups.	1 year
Late toxicity	Compare Late toxicity (using RTOG/EORTC Late Radiation Toxicity Scale)	1 year
Overall survival (OS)	Compare overall survival in the study population	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Prostate Cancer; Hypofractionated Radiotherapy; Intermediate Risk Prostate Cancer; High Risk Prostate Cancer; Pelvic Lymph Node Irradiation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: RO2002-30906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No