Clinical Trials /

Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

NCT03889119

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 115-16-CA
  • NCT ID: NCT03889119

Conditions

  • Prostate Cancer

Purpose

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.

Detailed 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.
    

Trial Arms

NameTypeDescriptionInterventions
Elekta Versa HDActive ComparatorThis 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.
    Agility SystemsOtherThis study seeks to investigate biochemical failure rates for patients treated with SBRT utilizing Agility Systems, as well as obtain quality of life data and assess the intrafraction motion in approximately 15 patients for 5 years following SBRT.

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Histologically confirmed diagnosis of adenocarcinoma of the prostate History/physical
                   examination with digital rectal examination of the prostate
      
                -  Histological evaluation of prostate biopsy with assignment of Gleason score to the
                   biopsy material.
      
                -  Clinical stage T1-3 (AJCC 7th edition).
      
                -  Males age ≥ 18
      
                -  Patient must be able to provide study-specific informed consent prior to study entry.
      
                -  Willingness and ability to complete the Expanded Prostate Cancer Index Composite
                   (EPIC) questionnaire
      
              Exclusion Criteria:
      
                -  Evidence of distant metastases
      
                -  Regional lymph node involvement
      
                -  Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer
      
                -  Previous pelvic irradiation, prostate brachytherapy
      
                -  Previous or concurrent cytotoxic chemotherapy for prostate cancer
      
              There are no exclusions due to co-morbid disease or illnesses except for patients with
              severe inflammatory bowel disease
      
              No life expectancy restrictions will apply
      
              Performance Status will not be considered
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:The primary aim of this study is to examine biochemical failure rates after SBRT for patients with low, intermediate, and high risk localized non-metastatic prostate cancer.
      Time Frame:5 years
      Safety Issue:
      Description:The number of patients demonstrating biochemical failure will be assessed. Biochemical failure will be defined using the Phoenix definition (Roach et al. IJROBP 2006), which is defined as a rise above nadir PSA + 2 ng/ml.

      Secondary Outcome Measures

      Measure:The secondary aim is to obtain quality of life data to examine the potential complications associated with SBRT: detailed symptom questionnaire
      Time Frame:5 years
      Safety Issue:
      Description:Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) (Chang J Urol 2011) total symptom score change from baseline will be assessed. This total score ranges from 0-60, with higher scores representing more symptoms.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Hoag Memorial Hospital Presbyterian

      Last Updated

      March 25, 2019