Status:
UNKNOWN
Trial Comparing Radical Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer
Lead Sponsor:
Cairo University
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
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 wi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05285319
Start Date
February 9 2020
End Date
April 1 2023
Last Update
August 10 2022
Active Locations (1)
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1
National Cancer Institute - Cairo University
Cairo, Egypt