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

NCT05285319 | Unknown Phase 2

• 1 other identifier: RO2002-30906
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Intermediate Risk Prostate Cancer; High Risk Prostate Cancer; Hypofractionated Radiotherapy; Pelvic Lymph Node Irradiation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Biochemical free survivals (BFS)

  1 year

• Late toxicity

  1 year

• Overall survival (OS)

  1 year

Study Arms (2)

Prostate Only (Arm A)

EXPERIMENTAL

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

Radiation: Prostate Only Radiation

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)

Radiation: Prostate and Pelvic Lymph Node Radiation

Interventions

Prostate Only Radiation RADIATION

Prostate Only Radiation for Intermediate and High Risk Prostate cancer

Prostate Only (Arm A)

Prostate and Pelvic Lymph Node Radiation RADIATION

Prostate and Pelvic Lymph Node Radiation for Intermediate and High Risk Prostate cancer

Prostate and Pelvic Lymph Nodes (Arm B)

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Cancer Institute - Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Ahmed Abdelhamid, Msc

CONTACT

+201203262526; ahmed.abdelhamid@nci.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer Of Radiation Oncology - National Cancer Institute

Model Details: 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)

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: February 9, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

EG (1)