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

Phase 2

• Conditions: Prostate Cancer
• Interventions: Radiation: Prostate Only Radiation; Radiation: Prostate and Pelvic Lymph Node Radiation

• Registration Number: NCT05285319
• Lead Sponsor: Cairo University

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)

Study Timeline

• Study Start: 2020-02-09
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-17
• Primary Completion: 2022-04-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 82

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prostate Only (Arm A)	Prostate Only Radiation	Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to a dose of 60Gy/20fractions (3 Gy per fraction)
Prostate and Pelvic Lymph Nodes (Arm B)	Prostate and Pelvic Lymph Node Radiation	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)

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

National Cancer Institute - Cairo University; 🇪🇬 Cairo, Egypt