Acute Toxicity After Moderate Hypo-fractionated Intensity Modulated Radiotherapy IMRT or Prostate Cancer

NCT05265364 | Unknown DMC

• 1 other identifier: MansouraUH
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

External radiation techniques (EBRT) is considered one of the primary therapies for patients of all risk classifications of prostate cacer . EBRT aims to control tumor growth while keeping acute and late adverse events to a minimum and ensuring biochemical progression-free outcome

Conditions

Radiation Toxicity

Outcome Measures

Primary Outcomes (1)

• Primary end point is to asses acute toxicity of moderate hypo-fractionation using intensity-modulated radiotherapy (IMRT) with a simultaneous integrated boost (SIB) in prostate cancer patients

  according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  Acute toxicities will be reported within the initial 18 week of starting radiotherapy

Secondary Outcomes (1)

• Secondary end point is to asses late toxicity

  will be recorded after 3 months of end of radiotherapy according to Common Terminology Criteria for Adverse Events (CTCAE)version 5.0 .

Interventions

IMRT with SIB RADIATION

moderate hypofractioation using 2.5gy/fr in prostate cancer patients usig IMRT SIB technique

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

male patients with prostate cancer proved pathologically non metastatic

You may qualify if:

• \- Age \>40 Pathologically proved prostate cancer Patients with unfavorable intermediate, High. very high risk groups and N1disease (Metastases in regional node(s)

You may not qualify if:

• Patients with prior pelvic irradiation. history of collagen vascular . inflammatory bowel disease. Double malignancy.

Sponsors & Collaborators

• hanan fawzy: lead

Study Sites (1)

Clinical Oncology and Nuclear Medicin Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Radiation Injuries

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• hanan fawzy

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: specialist of clinical oncology and nuclear medicin

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 3, 2022
• Study Start: July 25, 2022
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)