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

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

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.

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)

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)