Skip to main content
OpenTrials
Completed

NCT Number: NCT03664193

MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer

Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

About this study

Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5, or 2 Gy per fraction for a total dose of 37.5, 40, 42.5 or 45 Gy to biopsy-proven lesions, defined using MRI.

Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate nodules and deliver a higher radiation dose, to achieve maximal local control without increasing treatment toxicity

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy-proven diagnosis of prostate adenocarcinoma
  • NCCN defined low-, intermediate- and high-risk prostate cancer
  • Age ≥ 18
  • Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA positron emission tomography (PET) with an avid intraprostatic lesion

Exclusion criteria

  • History of prior pelvic radiation (external beam or brachytherapy)
  • Inability to undergo MRI
  • Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study
  • American Urological Association (AUA) score >17 - AUA score >17

Treatment and study plan

SIBRT

Radiation

Patients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.

Primary outcomes

  1. Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB).

    Time frame: 2 months

    Feasibility of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB). The investigators will track the number of treatment plans(number of participants) for each dose level (37.5, 40, 42.5, or 45 Gy) that can be delivered while meeting radiation planning objectives.

  2. Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities.

    Time frame: 1month

Secondary outcomes

  1. Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients.

    Time frame: baseline, 3-6 months post treatment start

    Health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) short-form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.

  2. American Urological Association (AUA) Questionnaire Will be Assessed.

    Time frame: baseline, 3-6 months post treatment start

    Health-related quality of life (HRQOL) measured using the AUA assessment will occur at baseline, and at first follow up. The American Urological Association (AUA) has developed the following questionnaire to help men determine how bothersome their urinary symptoms are and to check how effective their treatment is. 0-7 is mild, 8-19 is moderate and 20-35 is severe.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Acronym: SIBRT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2018
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.