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

Cairo University (CU)

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: Prostate and Pelvic Lymph Node Radiation; Radiation: Prostate Only Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT05285319

RO2002-30906

Details and patient eligibility

About

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.

Full 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)

Enrollment: 82 estimated patients

Sex: Male

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Prostate Only (Arm A)

Experimental group

Description:

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

Treatment:

Radiation: Prostate Only Radiation

Prostate and Pelvic Lymph Nodes (Arm B)

Experimental group

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)

Treatment:

Radiation: Prostate and Pelvic Lymph Node Radiation