Clinical trial NCT05285319: Trial Comparing Radical Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Intermediate Risk Prostate Cancer
High Risk Prostate Cancer
Hypofractionated Radiotherapy
Pelvic Lymph Node Irradiation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 82
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase II prospective randomized trial with 2 arms:

* Prostate Only (Arm A)

  o 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)
Primary purpose: TREATMENT

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Acute toxicity
timeFrame: 90 days post the end of radiation therapy
measure: Local Control
timeFrame: 1 year
Secondary outcomes:
measure: Biochemical free survivals (BFS)
timeFrame: 1 year
measure: Late toxicity
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute - Cairo University
Study officials:
References: