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 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Prostate Only Radiation for Intermediate and High Risk Prostate cancer
Prostate and Pelvic Lymph Node Radiation for Intermediate and High Risk Prostate cancer
National Cancer Institute - Cairo University
Cairo, Egypt
RECRUITINGAcute toxicity
Compare Acute toxicity between the 2 arms using Radiation Therapy Oncology Group (RTOG) acute morbidity scoring criteria.
Time frame: 90 days post the end of radiation therapy
Local Control
Compare Local control (LC) with minimum follow up of 1 year in both groups
Time frame: 1 year
Biochemical free survivals (BFS)
Biochemical free survivals (BFS) with minimum follow up of 1 year in both groups.
Time frame: 1 year
Late toxicity
Compare Late toxicity (using RTOG/EORTC Late Radiation Toxicity Scale)
Time frame: 1 year
Overall survival (OS)
Compare overall survival in the study population
Time frame: 1 year
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