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

Radiation Toxicity Clinical Trial

Official title:

Acute and Late Toxicity After Moderate Hypo-fractionated Intensity Modulated Radiotherapy (IMRT) With Simultaneous Integrated Boost (SIB) for Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05265364
• Other study ID #: MansouraUH
• Status: Active, not recruiting
• Start date: July 25, 2022
• Est. completion date: December 12, 2024

Study information

• Verified date: October 2023
• Source: Mansoura University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Patients and methods This is a prospective study of at least 50 patients to record acute and late toxicity using moderate hypo-fractionation with simultaneous integrated boost (SIB) IMRT for Prostate Cancer.Data will be collected at Clinical Oncology and Nuclear Medicine Department Mansoura University and Oncology Center Tanta University from January 2022 to December 2024 Patients Eligibility criteria Age >40 Pathologically proved prostate cancer Patients with unfavorable intermediate, High. very high risk groups and N1disease (Metastases in regional node(s) Risk groups according to NCCN guidelines 2021 and new grade grouping system of International Society of Urological Pathology (ISUP) Consensus Conference 2014

Unfavorable intermediate risk group :

exclusion criteria: Patients with prior pelvic irradiation. history of collagen vascular . inflammatory bowel disease. Double malignancy.

Methods Data acquisition planning computed tomography (CT) imaging will be performed in supine position using knee and ankle fixation support system for immobilization of the legs and patients arms on their chest.

Axial images will be obtained with 3-5 mm slice thickness from L1 vertebra to about 3 cm below the ischial tuberosity.

Before planning CT, patients will be instructed to have moderately, comfortably filled bladder and empty rectum four tattoos will be marked on the skin at the time of planning CT, rectum, bladder and hip joints will be contoured as organs at risk (OARs).

Target volumes

The prostate clinical target volume (CTV-pros) :

Include the whole prostate gland.

Prostate and seminal vesicles CTV (CTV-psv) :

Generated by 5mm expansion of CTV-pros in all directions except posteriorly at the prostate-rectum interface + proximal 2 cm of the seminal ( in case of cT3b the entire seminal vesicles will be included) .

Whole pelvis clinical target volume (CTV-pelv):

Consist of CTV-psv + common iliac (under L5-S1 space), external iliac, presacral and obturator lymph nodes.

Dose and fractionation All patients will receive moderate hypo fractionation with step and shoot IMRT with SIB in 28 fractions using 6-10 MV photon beams they will receive 70 Gy to PTV-pros in 2.5Gy/fraction and 57.4 Gy to PTV-psv in 2.05 Gy/fraction 50.4 Gy to the pelvic lymph nodes using 1.8 Gy/fraction for PTV coverage, the 95% of the prescribed dose will cover 95% of the target volume (V95% > 95%) for all PTVs. Rectum V45Gy, V63Gy, bladder V45Gy, hip joints V45Gy will be constrained below 50%, 20%, 65% and 10% of their volumes respectively.

Treatment delivery and care Before treatment a detailed medical history will be recorded and physical examination including PSA , pretreatment bone scan and pelvi -abdominal CT +/- MRI will be required to stage the prostate cancer and to exclude distant metastases.

Intermediate risk patients with bulky disease or un- favorable histological parameters will receive neo-adjuvant and concomitant hormone for 4-6 months (short-term hormone therapy) and in high risk patients neo-adjuvant ,concomitant and adjuvant hormone therapy for 24-36 months (long-term hormone therapy).

Patients will be evaluated every second week during the treatment, every three months after radiation therapy for the first year .

Acute toxicities will be reported during radiation therapy and within the initial 3-month and late toxicity will be recorded thereafter according to Common Terminology Criteria for Adverse Events (CTCAE)version 5.0 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 12, 2024
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Radiation Toxicity

Intervention

Radiation:
• IMRT with SIB
moderate hypofractioation using 2.5gy/fr in prostate cancer patients usig IMRT SIB technique

Locations

Country	Name	City	State
Egypt	Clinical Oncology and Nuclear Medicin Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
hanan fawzy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary end point is to asses late toxicity	using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	will be recorded after 3 months of end of radiotherapy according to Common Terminology Criteria for Adverse Events (CTCAE)version 5.0 .