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.
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
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
Name | Type | Description | Interventions |
---|
Elekta Versa HD | Active Comparator | 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. | |
Agility Systems | Other | This 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: | Active, not recruiting |
Lead Sponsor: | Hoag Memorial Hospital Presbyterian |
Last Updated
August 25, 2021