Trial Comparing Radical Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Acute toxicity [90 days post the end of radiation therapy]
Compare Acute toxicity between the 2 arms using Radiation Therapy Oncology Group (RTOG) acute morbidity scoring criteria.
- Local Control [1 year]
Compare Local control (LC) with minimum follow up of 1 year in both groups
Secondary Outcome Measures
- Biochemical free survivals (BFS) [1 year]
Biochemical free survivals (BFS) with minimum follow up of 1 year in both groups.
- Late toxicity [1 year]
Compare Late toxicity (using RTOG/EORTC Late Radiation Toxicity Scale)
- Overall survival (OS) [1 year]
Compare overall survival in the study population
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Cancer Institute - Cairo University | Cairo | Egypt |
Sponsors and Collaborators
- Cairo University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RO2002-30906