Radiotherapy for Prostate Cancer
DESCRIPTION
Prostate cancer forms in the tissues of the prostate in the male reproductive system. According to statistics from the American Cancer Society, It is the second most common cancer in American men. Prostate cancer treatment options are surgery, chemotherapy, cryotherapy, hormonal therapy, and/or radiation.
Radiotherapy for prostate cancer addressed by this policy include:
External Beam Radiation Therapy (EBRT)
EBRT has been widely used in the treatment of prostate cancer since the late 1950's. The radiation is focused from a source outside the body onto the area affected. The location of the prostate is defined according to the anatomy of nearby structures without the use of three-dimensional (3-D) visualization. Computed tomography (CT) images can be used to shape the radiotherapy fields to conform more closely to that of the prostate itself.
Interstitial Radiotherapy (Brachytherapy) - Permanent Seed Implantation
Brachytherapy for permanent seed implantation has been proposed for use in the treatment of localized prostate cancer as an alternative or complement to EBRT. It involves radioactive isotopes being directly implanted into the prostate gland as permanent seeds. The volume and shape of the prostate is accurately mapped out prior to surgery by use of transperineal CT or by ultrasound images. Needle placement and seed distribution is customized and evaluated by computer dosimetry planning systems. The number of seeds implanted is determined by the size of the prostate. The dose to the prostate is optimized and dose to the bladder and rectum is minimized by adjustment to seed placement and strength. This treatment is usually done as a single outpatient procedure with the use of spinal anesthesia.
Conformal Three-Dimensional (3-D) Radiotherapy
This type of radiotherapy uses digital information obtained with computed tomography (CT) scanners to obtain 3-D visualization of the prostate and nearby structures. The prostate, seminal vesicles, and surrounding normal tissue can be localized within the individual receiving the treatment. The radiation fields can then be tailored to the shape of the target tissue, thereby directing the highest dose of radiation to the malignant cells. The individual receiving treatment is fitted with a plastic mold resembling a body cast. The plastic mold is used to minimize movement so that the radiation can be more accurately aimed from several directions. More accurately aimed radiation may help to reduce radiation damage to normal tissues near the tumor.
Mixed-Beam (Photon/Neutron) Radiotherapy
Mixed-beam radiotherapy combines the higher therapeutic benefits of the neutron beam with the lower toxicity of the photon beam. This is done in an attempt to achieve tumor control in prostate cancer.
Other forms of radiotherapy for prostate cancer that have been investigated in clinical settings but are not addressed by this policy include:
Proton or Helium Ion Beam (Charged Particle) Radiation Therapy
See Proton or Helium Ion Beam (Charged Particle) Radiation Therapy policy (hyperlink below).
High-dose Rate Temporary Prostate Brachytherapy
In this technique of delivering a high-intensity radiation source directly to the prostate gland the radiation source is precisely inserted through hollow catheters into several areas of the prostate gland using ultrasound guidance and treatment planning computed tomography (CT) or ultrasound images. The radiation source is allowed to dwell in the target areas until the prescribed radiation dose is reached and is then removed with the goal of increasing direct tumor necrosis while reducing toxicity and surrounding tissue damage.
Intensity Modulated Radiation Therapy
Intensity modulated radiation therapy is an advanced form of 3-dimensional conformal radiation therapy.) Enhanced conformation allows for greater doses of radiation to reach the target volume while delivering less radiation to surrounding normal tissues. Intensity modulated radiation therapy, like 3-dimensional conformal radiation therapy, uses multiple beams, with the shape of each beam conforming to the target; however, unlike 3-dimensional conformal radiation therapy, the intensity of radiation within any given beam varies such that normal organs are spared compared with target tissues.
POLICY
External beam radiation therapy (EBRT) for the treatment of prostate cancer is considered medically necessary.
Brachytherapy without external beam radiation for localized prostate cancer is considered medically necessary.
Conformal three-dimensional (3-D) radiotherapy for the treatment of prostate cancer is considered medically necessary.
Mixed-beam (Photon-Neutron) radiotherapy for the treatment of prostate cancer is considered investigational.
Brachytherapy, with external beam radiation, for treatment of localized prostate cancer is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication otherwise it will be considered investigational.
See also:
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of mixed-beam (photon-neutron) radiotherapy and brachytherapy with external beam radiation for the treatment of localized prostate cancer compared to alternative treatments.
SOURCES
American College of Radiology. (2011). ACR appropriateness criteria for locally advanced (high risk) prostate cancer. Retrieved August 22, 2011 from http://www.guideline.gov/.
American College of Radiology. (2010). ACR appropriateness criteria for permanent source brachytherapy for prostate cancer. Retrieved August 22, 2011 from http://www.guideline.gov/.
American Urological Assciation. (2007) Guideline for the management of clinically localized prostate cancer. Retrieved August 22, 2011 from http://www.guideline.gov/.
Biagioli, M., Hoffe, S. (2010). Emerging technologies in prostate cancer radiation therapy: Improving the therapeutic window. Cancer Control, 17 (4), 223-232.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2002). Brachytherapy for clinically localized prostate cancer using permanently implanted seeds (8.01.14). Retrieved August 19, 2011 from BlueWeb.
Dattoli, M., Wallner, K., True, L., Bostwick, D., Cash, J., &Sorace, R. (2010). Long term outcomes for patients with prostate cancer having intermediate and high risk disease, treated with combination external beam irradiation and brachytherapy. Journal of Oncology, 2010 (epub),
National Comprehensive Cancer Network. (2011, April). Clinical practice guidelines in oncology-v.4.2011: Prostate cancer. Retrieved August 19, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.
National Institute for Health and Clinical Excellence. (2008, February). Prostate cancer, diagnosis and treatment. Retrieved August 19, 2011 from http://www.nice.org.uk/nicemedia/live/11924/39687/39687.pdf.
National Institute for Health and Clinical Excellence. (2006, May). High dose rate brachytherapy in combination with external-beam radiotherapy for localized prostate cancer. Retrieved August 19, 2011 from http://www.nice.org.uk/nicemedia/live/11215/31529/31529.pdf.
National Institute for Health and Clinical Excellence. (2005, July). Low dose rate brachytherapy for localized prostate cancer. Retrieved August 19, 2011 from http://www.nice.org.uk/nicemedia/live/11150/31307/31307.pdf.
U. S. Food and Drug Administration. (2005, February). Center for Devices and Radiological Health. 510(k) summary of safety and effectiveness. Retrieved August 19, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/K043246.pdf.
U. S. Food and Drug Administration. (2006, November). Center for Devices and Radiological Health. 510(k) summary of safety and effectiveness. Retrieved August 19, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062384.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2006, November). Conformal and intensity modulated radiation therapy for prostate cancer. Retrieved August 19, 2011 from www.Hayesinc.com/subscribers. (94 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 8/1983
MOST RECENT REVIEW DATE: 1/12/2012
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.