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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Prostate Only Radiation
Prostate and Pelvic Lymph Node Radiation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Intermediate Risk Prostate Cancer, High Risk Prostate Cancer, Hypofractionated Radiotherapy, Pelvic Lymph Node Irradiation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • National Cancer Institute - Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prostate Only (Arm A)

Prostate and Pelvic Lymph Nodes (Arm B)

Arm Description

Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to a dose of 60Gy/20fractions (3 Gy per fraction)

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)

Outcomes

Primary Outcome Measures

Acute toxicity
Compare Acute toxicity between the 2 arms using Radiation Therapy Oncology Group (RTOG) acute morbidity scoring criteria.
Local Control
Compare Local control (LC) with minimum follow up of 1 year in both groups

Secondary Outcome Measures

Biochemical free survivals (BFS)
Biochemical free survivals (BFS) with minimum follow up of 1 year in both groups.
Late toxicity
Compare Late toxicity (using RTOG/EORTC Late Radiation Toxicity Scale)
Overall survival (OS)
Compare overall survival in the study population

Full Information

First Posted
March 9, 2022
Last Updated
August 9, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05285319
Brief Title
Trial Comparing Radical Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Intermediate Risk Prostate Cancer, High Risk Prostate Cancer, Hypofractionated Radiotherapy, Pelvic Lymph Node Irradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prostate Only (Arm A)
Arm Type
Experimental
Arm Description
Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to a dose of 60Gy/20fractions (3 Gy per fraction)
Arm Title
Prostate and Pelvic Lymph Nodes (Arm B)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Radiation
Intervention Name(s)
Prostate Only Radiation
Intervention Description
Prostate Only Radiation for Intermediate and High Risk Prostate cancer
Intervention Type
Radiation
Intervention Name(s)
Prostate and Pelvic Lymph Node Radiation
Intervention Description
Prostate and Pelvic Lymph Node Radiation for Intermediate and High Risk Prostate cancer
Primary Outcome Measure Information:
Title
Acute toxicity
Description
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
Title
Local Control
Description
Compare Local control (LC) with minimum follow up of 1 year in both groups
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Biochemical free survivals (BFS)
Description
Biochemical free survivals (BFS) with minimum follow up of 1 year in both groups.
Time Frame
1 year
Title
Late toxicity
Description
Compare Late toxicity (using RTOG/EORTC Late Radiation Toxicity Scale)
Time Frame
1 year
Title
Overall survival (OS)
Description
Compare overall survival in the study population
Time Frame
1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelhamid, Msc
Phone
+201203262526
Email
ahmed.abdelhamid@nci.cu.edu.eg
Facility Information:
Facility Name
National Cancer Institute - Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelhamid
Phone
+201203262526
Email
ahmed.abdelhamid@nci.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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