Trial Comparing Radical Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer
NCT ID: NCT05285319
Last Updated: 2022-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
82 participants
INTERVENTIONAL
2020-02-09
2023-04-01
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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)
TREATMENT
NONE
Study Groups
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Prostate Only (Arm A)
Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to a dose of 60Gy/20fractions (3 Gy per fraction)
Prostate Only Radiation
Prostate Only Radiation for Intermediate and High Risk Prostate cancer
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)
Prostate and Pelvic Lymph Node Radiation
Prostate and Pelvic Lymph Node Radiation for Intermediate and High Risk Prostate cancer
Interventions
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Prostate Only Radiation
Prostate Only Radiation for Intermediate and High Risk Prostate cancer
Prostate and Pelvic Lymph Node Radiation
Prostate and Pelvic Lymph Node Radiation for Intermediate and High Risk Prostate cancer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
MALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Abdelhamid
Assistant Lecturer Of Radiation Oncology - National Cancer Institute
Locations
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National Cancer Institute - Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RO2002-30906
Identifier Type: -
Identifier Source: org_study_id
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