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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285319
• Other study ID #: RO2002-30906
• Status: Recruiting
• Phase: Phase 2
• Start date: February 9, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2022
• Source: Cairo University
• Contact: Ahmed Abdelhamid, Msc
• Phone: +201203262526
• Email: ahmed.abdelhamid[@]nci.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Egypt	National Cancer Institute - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Local Control	Compare Local control (LC) with minimum follow up of 1 year in both groups	1 year
Secondary	Biochemical free survivals (BFS)	Biochemical free survivals (BFS) with minimum follow up of 1 year in both groups.	1 year
Secondary	Late toxicity	Compare Late toxicity (using RTOG/EORTC Late Radiation Toxicity Scale)	1 year
Secondary	Overall survival (OS)	Compare overall survival in the study population	1 year