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)
Age
Any age
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Clareo Health | Trial Comparing Radical Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer
