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

NCT07489729 | Completed

• 1 other identifier: 35544/6/22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is

1. 1.Statistical evaluation of patients' characteristics who have intermediate \& high risk localized prostate cancer.
2. 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. 3.Evaluation of acute as well as late toxic side effects after radiotherapy.

Conditions

Hypofractionated Dose; Prostate Cancer Patients

Keywords

Prostate cancer; Hypo fractionated intensity-modulated radiotherapy; toxicity

Outcome Measures

Primary Outcomes (1)

• 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.

  Three monthly the first year after radiation, 4 months the second and third year.

Secondary Outcomes (1)

• Overall survival

  3 years

Study Arms (2)

Group A

ACTIVE COMPARATOR

hypofractionated Intensity-Modulated Radiation Therapy

Radiation: Hypofractionated Intensity-Modulated Radiation Therapy

Group B

ACTIVE COMPARATOR

conventional fractionated Intensity-Modulated Radiation Therapy

Radiation: Conventional Intensity-Modulated Radiation Therapy

Interventions

Hypofractionated Intensity-Modulated Radiation Therapy RADIATION

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).

Group A

Conventional Intensity-Modulated Radiation Therapy RADIATION

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.

Group B

Eligibility Criteria

• Age: 50 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Nada El-Behiri

  Assistant lecturer of Clinical Oncology& Nuclear Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: June 30, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 24, 2026

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)