Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Stereotactic Body Radiation Therapy (SBRT) for the Management of Carcinoma of the Prostate: Quality of Life Data After Primary Stereotactic Body Radiation Therapy for Localized Prostate Cancer

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to learn the long term efficacy and side effects associated with utilizing Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System. SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer.

Traditional External beam radiation therapy (EBRT) for prostate carcinoma is typically done over the course of approximately 42-45 daily treatments SBRT is a way to condense this treatment into a course of 5 treatments, delivering more dose per day.

Clinical Trial Description

Prostate cancer is the most common cancer diagnosed in men, and ranks second in estimated deaths. The current standard of care for localized prostate cancer consists of observation, surgery or radiation therapy. From a radiation perspective, accepted options include external beam radiation therapy, brachytherapy, or a combination of those. Acceptable external beam radiation options are further defined as conventionally fractionated (over approximately 8-9 weeks), or moderately hypo-fractionated (over approximately 4-6 weeks).

Stereotactic body radiation therapy (SBRT) is a newer technique, allowing treatment to be delivered in an extremely hypo-fractionated regimen (i.e. in 5 fractions). Current consensus guidelines describe SBRT as "a cautious alternative to conventionally fractionated regimens at clinics with appropriate technology, physics, and clinical expertise."

The goal of any therapy is to maximize the effect of that treatment on cancer cells and minimize any effect on normal tissue. In radiation therapy, this is mainly done through dose targeting (i.e. limiting the radiation dose to the targets and minimizing dose to normal surrounding organs). Advancements in radiation therapy have allowed for better targeting, resulting in shrinking margins of treatment around cancer cells.

The therapeutic window can also be optimized through the use of fractionation (i.e. amount of dose delivered per day) in radiation therapy. Since cancerous and normal tissue cells respond differently to changes in fractionation, the therapeutic window could theoretically be improved by choosing a fractionation pattern to which cancer cells are more sensitive. Historical generalizations put cancer cells into the category of early responding tissues, which would make them more sensitive to cell death when radiation is delivered in a protracted fractionation pattern, such as over 8-9 weeks of radiation therapy.

However, studies have emerged which suggest that prostate cancer is unlike other cancers and reactive more like late responding tissues. With that in mind, prostate cancer cells could be more sensitive to high doses per fraction, which could provide a radiobiological advantage and a greater therapeutic window with the use of SBRT.

Very promising early results utilizing SBRT for prostate cancer treatment have been described in the literature, and multiple ongoing phase 3 trials are underway.

Aside from a potential therapeutic advantage, SBRT also offers a more cost effective solution to patients with prostate cancer, with less impact on their daily lives (only needing to come in for 5 treatments instead of 40-45 treatments).

Much of the literature on SBRT has been done utilizing the CyberKnife system. But the Elekta Versa HD and Agility Systems available at Hoag provides a unique opportunity for faster treatment delivery and 4D imaging during treatment. The Elekta Versa HD and Agility systems are approved by the FDA for SBRT treatment of cancer.

This study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Elekta machines, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT03889119
• Study type: Interventional
• Source: Hoag Memorial Hospital Presbyterian
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 21, 2016
• Completion date: December 31, 2025