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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Only (Arm A) | Experimental | Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to a dose of 60Gy/20fractions (3 Gy per fraction) |
|
| Prostate and Pelvic Lymph Nodes (Arm B) | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate Only Radiation | Radiation | Prostate Only Radiation for Intermediate and High Risk Prostate cancer |
|
| 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 |
| 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) |
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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:
N stage: N0
M Stage: M0
Performance Status: PS 0-2
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Abdelhamid, Msc | Contact | +201203262526 | ahmed.abdelhamid@nci.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute - Cairo University | Recruiting | Cairo | Egypt |
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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)
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| Prostate and Pelvic Lymph Node Radiation | Radiation | Prostate and Pelvic Lymph Node Radiation for Intermediate and High Risk Prostate cancer |
|
| 1 year |
| Overall survival (OS) | Compare overall survival in the study population | 1 year |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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