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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Prostate Only Radiation
* Radiation: Prostate and Pelvic Lymph Node Radiation


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase II prospective randomized trial with 2 arms: Prostate Only (Arm A) o 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate Only (Arm A)<br>Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to a dose of 60Gy/20fractions (3 Gy per fraction) | Radiation: Prostate Only Radiation<br>* Prostate Only Radiation for Intermediate and High Risk Prostate cancer<br>|
| Experimental: Prostate and Pelvic Lymph Nodes (Arm B)<br>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<br>* Prostate and Pelvic Lymph Node Radiation for Intermediate and High Risk Prostate cancer<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Intermediate Risk Prostate Cancer, High Risk Prostate Cancer, Hypofractionated Radiotherapy, Pelvic Lymph Node Irradiation