Rectal retractor in prostate cancer

Clinical evaluation and comparison of rectal toxicity and absorbed dose effects of radiation therapy with and without rectal retractor on patients with prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180919041070N4

Enrollment

Registered

2020-04-21

Start date

2019-10-22

Completion date

Unknown

Last updated

2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer. Malignant neoplasm of prostate

Interventions

Intervention 1: Intervention group: Patients who are treated with rectal retractor in order to retract the rectum and distance it from prostate, Intervention: A rectal retractor probe which is designe

Eligibility

Sex/Gender

Male

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with localized prostate cancer who are candidates for radiation therapy with 5 fields technique pathologically confirmed prostate cancer in patients who have not undergone prostate surgery

Exclusion criteria

Exclusion criteria: Anorectal disorders (Hemorrhoidsm, rectal fistula)

Design outcomes

Primary

Measure	Time frame
Early and late lower gastrointestinal complications grade based on Radiation therapy oncology group (RTOG) criteria. Timepoint: During treatment course, 1-3 months after treatment, 9-12 months after treatment. Method of measurement: according to Radiation therapy oncology group (RTOG) criteria.;Rectum to prostate distance in CT scan images. Timepoint: At the beginning of study (During intervention). Method of measurement: Axial CT scan images.	—

Measure

Time frame

Early and late lower gastrointestinal complications grade based on Radiation therapy oncology group (RTOG) criteria. Timepoint: During treatment course, 1-3 months after treatment, 9-12 months after treatment. Method of measurement: according to Radiation therapy oncology group (RTOG) criteria.;Rectum to prostate distance in CT scan images. Timepoint: At the beginning of study (During intervention). Method of measurement: Axial CT scan images.

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Secondary

Measure	Time frame
Maximum dose (Dmax). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).;Minimum dose (Dmin). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).;Mean dose (Dmean). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).;Dose 30% (D30%): The dose that covers 30% of rectum. Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).;Dose 50% (D50%): The dose that covers 50% of rectum. Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).;Dose volume histograms for rectum and planning treatment volume (PTV). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).	—

Measure

Time frame

Maximum dose (Dmax). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).;Minimum dose (Dmin). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).;Mean dose (Dmean). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).;Dose 30% (D30%): The dose that covers 30% of rectum. Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).;Dose 50% (D50%): The dose that covers 50% of rectum. Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).;Dose volume histograms for rectum and planning treatment volume (PTV). Timepoint: at the intervention time. Method of measurement: Radiation therapy treatment planning system (Varian Eclipse v.13.6 ).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahshid Abbasi

Iran University of Medical Sciences

mahshid.abbasi2011@gmail.com+98 21 8214 1201

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026