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

March 18, 2026 updated by: Nada Samir Shams El-Din El-Behiri, Tanta University

Hypo Fractionated Versus Conventional IMRT in Unfavorable Intermediate- and High-Risk Prostate Cancer: A Phase II Comparative Study of PSA Kinetics and Dosimetric Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The incidence rate of prostate cancer is rapidly increasing, and it has become the most prevalent solid tumor diagnosed in men.

In most cases the prostate cancer is organ-confined at the time of initial diagnosis . Radical prostatectomy and radiotherapy, either given as a seed implant or external beam radiation therapy, are the accepted standard options for treating the primary tumor itself, and androgen deprivation may be added selectively for certain cases with an intermediate or high risk of dissemination based on clinical and pathologic features evident at the time of diagnosis.

Regarding the specific option of external beam radiotherapy, the current widely accepted standard regimen for organ-confined prostate cancer involves approximately eight weeks of fractionated treatments with a daily dose of 1.8-2.0 Gy to a total dose in the range of 70-80 Gy .

Over the last decade, there have been three major advances in the use of external RT for the management of clinically localized prostate cancer: (a) androgen deprivation therapy ; (b) image-guided ration therapy with three-dimensional conformal radiotherapy and intensity modulated radiotherapy , and particularly c) radiation dose escalation schedules compared with conventional 70-80 Gy (2 Gy per fraction), which has been shown to improve biochemical and distant metastases control with minimum toxicity, but not overall survival .

The rapid dose gradients, which are able to be generated with Intensity Modulated Radiation Therapy have been demonstrated to reduce OAR dose relative to three-dimensional conformal radiotherapy resulting in well-established reductions in toxicity in the conventionally fractionated, dose escalated prostate cancer radiotherapy setting .

The use of conventional fractionated radiation therapy with a single 1.8-2 Gy fraction/day is related to more radiation therapy sessions and longer treatments; therefore, influencing the decision-making and patient non-adherence, since longer treatments can affect their financial situation (by not being able to work during radiotherapy) or cause a disruption in their daily life .

Hypofractionated Radiation Therapy and conventional fractionated radiation therapy schedules have been shown to be isoeffective in terms of incidence of biochemical control or late complications in several phase III trials .

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biopsy proven prostate adenocarcinoma
  • Patient has been classified as intermediate or high risk according to the National Comprehensive Cancer Network v2018 .
  • Clinically localized stage (cT2-T3b N0M0, using the AJCC 8th TNM classification) .
  • Eastern Cooperative Oncology Group performance status ranged from 0-1 . - Mean age was 65 years (range: 50-80 years).
  • a prostate-specific antigen test at the time of diagnosis ≥10 ng/ml.
  • Gleason scores range from 7 to 10.
  • The patient must not receive any cytotoxic anticancer therapy for prostate cancer prior to randomization.
  • Adequate hematological, hepatic, renal function tests

Exclusion Criteria:

  • Patients with a history of other malignancies, except: non-melanoma skin cancer.
  • Patients with any contraindication to pelvic radiotherapy: including, previous pelvic radiotherapy, inflammatory bowel disease or severe bladder irritability.
  • Patients who had prior surgical treatment for carcinoma of the prostate apart from trans-urethral resection,
  • Nodal or distant metastasis proven by a computed tomography pelvis or bone scan,
  • Co-morbidities as Congestive heart failure, recent myocardial infarction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
hypofractionated Intensity-Modulated Radiation Therapy
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).
Active Comparator: Group B
conventional fractionated Intensity-Modulated Radiation Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: Three monthly the first year after radiation, 4 months the second and third year.
Evaluation of tumor response will be performed by digital rectal examination, prostate-specific antigen, testosterone levels and Magnetic resonance imaging abdomen & pelvis with contrast 3-monthly the first year after radiation therapy, 4-monthly the second and third year.
Three monthly the first year after radiation, 4 months the second and third year.

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Nada El-Behiri, Assistant lecturer of Clinical Oncology& Nuclear Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35544/6/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available if it needed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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