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Hypo Fractionated Versus Conventional IMRT in Unfavorable Intermediate- and High-Risk Prostate Cancer

NCT07489729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-24

No results posted yet for this study

Summary

The aim of the study is

1. Statistical evaluation of patients' characteristics who have intermediate \& high risk localized prostate cancer.
2. Statistical analysis of treatment efficacy of combined hormonal therapy \& hypo fractionated intensity modulated radiotherapy compared with conventionally fractionated radiotherapy plus hormonal treatment as regard biochemical failure, disease free survival \& overall survival.
3. Evaluation of acute as well as late toxic side effects after radiotherapy.

Conditions

  • Hypofractionated Dose
  • Prostate Cancer Patients

Interventions

RADIATION

Hypofractionated Intensity-Modulated Radiation Therapy

Moderately hypofractionated schedule include 60 Gy in 20fx (3 Gy/fx) over 4 weeks (5 fractions/week). The prostate will be prescribed 60 Gy in 20 fx (3 Gy/fx). Proximal seminal vesicles will be prescribed 48-50 Gy in 2.4-2.5 Gy/fx, Entire seminal vesicles will be prescribed full dose (60 Gy) in case of evidence of seminal vesicle invasion on multi parametric MRI. If treating the elective pelvic LNs (risk of involvement \>20% according to roach formula), prescribed dose will be 44 Gy in 2.2 Gy/fx. A simultaneous integrated boost technique will be utilized with moderate hypo fractionation).

RADIATION

Conventional Intensity-Modulated Radiation Therapy

Conventional fractionation of 76 Gy in 38 fractions (5 fractions/week) at 2.0 Gy/fraction over 8 weeks. The prostate will be prescribed 76 Gy in 38 fractions (2 Gy/fx). Proximal seminal vesicles will be prescribed 54-66Gy (2Gy/fx), paying attention to bowel toxicity. Entire seminal vesicle will be prescribed full dose (76 Gy) in case of evident seminal vesicle invasion on MRI. If treating elective pelvic lymph nodes (risk of involvement \>20% according to roach formula), prescribed dose will be 45-50 Gy.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Nada El-Behiri · Assistant lecturer of Clinical Oncology& Nuclear Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07489729 on ClinicalTrials.gov