Hypofractionated DoseNCT07489729
Hypo Fractionated Versus Conventional IMRT in Unfavorable Intermediate- and High-Risk Prostate Cancer
A study testing Hypofractionated Intensity-Modulated Radiation Therapy and Conventional Intensity-Modulated Radiation Therapy in people with Hypofractionated Dose and Prostate Cancer Patients, run by Tanta University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Hypofractionated Dose, Prostate Cancer Patients
- What is being tested?
- Hypofractionated Intensity-Modulated Radiation Therapy and Conventional Intensity-Modulated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Statistical evaluation of patients' characteristics who have intermediate \& high risk localized prostate cancer.
- 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.
- Evaluation of acute as well as late toxic side effects after radiotherapy.
Read the 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
- Statistical evaluation of patients' characteristics who have intermediate \& high risk localized prostate cancer.
- 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.
- Evaluation of acute as well as late toxic side effects after radiotherapy.
- Conditions
- Hypofractionated Dose, Prostate Cancer Patients
- Being tested
- Hypofractionated Intensity-Modulated Radiation Therapy, Conventional Intensity-Modulated Radiation Therapy
- Keywords
- Prostate cancer, Hypo fractionated intensity-modulated radiotherapy, toxicity
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Intensity-Modulated Radiation TherapyRadiation
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).
Conventional Intensity-Modulated Radiation TherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | hypofractionated Intensity-Modulated Radiation Therapy Receives: Radiation: Hypofractionated Intensity-Modulated Radiation Therapy |
| Group B | Active comparator | conventional fractionated Intensity-Modulated Radiation Therapy Receives: Radiation: Conventional Intensity-Modulated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
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.
Measured: Three monthly the first year after radiation, 4 months the second and third year.
Secondary outcomes (1)
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start30 Jun 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypofractionated DoseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Samir Shams El-Din El-Behiri, Tanta University
- Investigators
- Nada El-Behiri, Principal investigator, Assistant lecturer of Clinical Oncology& Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489729
- Sponsor's protocol ID
- 35544/6/22
- Status last verified
- Jun 2022
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypo Fractionated Versus Conventional IMRT in Unfavorable Intermediate- and High-Risk Prostate Cancer: A Phase II Comparative Study of PSA Kinetics and Dosimetric Outcomes
- ClinicalTrials.gov ID
- NCT07489729
- Acronym / sponsor ID
- 35544/6/22
- Conditions
- Hypofractionated Dose, Prostate Cancer Patients
- Keywords
- Prostate cancer, Hypo fractionated intensity-modulated radiotherapy, toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is
- Statistical evaluation of patients' characteristics who have intermediate \& high risk localized prostate cancer.
- 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.
- Evaluation of acute as well as late toxic side effects after radiotherapy.
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
- Statistical evaluation of patients' characteristics who have intermediate \& high risk localized prostate cancer.
- 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.
- Evaluation of acute as well as late toxic side effects after radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Radiation: Hypofractionated Intensity-Modulated Radiation Therapyhypofractionated Intensity-Modulated Radiation Therapy |
| Group B | Active comparator | Radiation: Conventional Intensity-Modulated Radiation Therapyconventional fractionated Intensity-Modulated Radiation Therapy |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Intensity-Modulated Radiation TherapyModerately 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 | Group A |
| Conventional Intensity-Modulated Radiation TherapyConventional 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. | Radiation | Group B |
Primary outcome
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.
1 secondary outcome
Overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be available if it needed
Related trials for Hypofractionated Dose
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A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer
Limited Stage Small-Cell Lung Cancer
Recruiting
Evaluating Tolerability of ePUHRT With Brachytherapy Boost
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Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer
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Active, not recruitingPhase 2
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Spinal Metastases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nada El-Behiri principal investigator
Assistant lecturer of Clinical Oncology& Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Intensity-Modulated Radiation Therapy and Conventional Intensity-Modulated Radiation Therapy in people with Hypofractionated Dose and Prostate Cancer Patients, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response (time frame: Three monthly the first year after radiation, 4 months the second and third year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.