BlueCross BlueShield of Tennessee Medical Policy Manual

Radiotherapy for Prostate Cancer

DESCRIPTION

The prostate is a gland found only in males, it sits just below the bladder and in front of the rectum. The prostate gland tends to get bigger as men get older. This is called benign prostatic hyperplasia, or BPH. BPH is not cancer and it does not lead to cancer. Prostate cancer is the second most common cancer in American men. Prostate cancer treatment options include: surgery, chemotherapy, cryotherapy, hormonal therapy, and/or radiation therapy.

Radiotherapy options 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. EBRT uses 2-dimensional treatment planning based on flat images and radiation beams with cross-sections of uniform intensity that were sequentially aimed at the tumor along 2 or 3 intersecting axes.

Permanent Brachytherapy - Low-dose Rate (LDR)

Brachytherapy with permanent radioactive seed implantation for use in the treatment of localized prostate cancer as an alternative or complement to EBRT. 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. Permanent brachytherapy combined with EBRT is used, sometimes along with androgen deprivation, to treat higher risk disease.

Temporary Brachytherapy- High-dose Rate (HDR)

High-intensity radiation is precisely delivered directly to the prostate gland through temporary implants using ultrasound guidance and 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 then removed with the goal of increasing direct tumor necrosis while reducing toxicity and surrounding tissue damage (e.g. rectum and urethra). HDR can be used as monotherapy and as a boost in combination with external beam radiation therapy.

When HDR brachytherapy is used following failed radiotherapy it is referred to as ‘salvage’ therapy. Data on HDR brachytherapy as salvage treatment are too limited to determine the impact on health outcomes.

Conformal Three-Dimensional (3-D) Radiotherapy

Three-dimensional images, usually from computed tomography (CT) scans, delineate the boundaries of the tumor and discriminate tumor tissue from adjacent normal tissue and nearby organs at risk for radiation damage. Computer algorithms were developed to estimate cumulative radiation dose delivered to each volume of interest by summing the contribution from each shaped beam. 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, thereby reducing radiation damage to normal tissues near the tumor.

Mixed-Beam (Photon/Neutron) Radiotherapy

Mixed-beam radiotherapy is a form of EBRT that combines the potentially higher therapeutic benefits of the neutron beam with the lower toxicity of the photon beam. Neutron beam therapy uses accelerated neutral subatomic particles to target tumor mass using a high linear energy transfer which is associated with greater cell killing per unit dose and proposes to be superior in overcoming radioresistance in tumor mass.

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

Proton or helium ion beam (charged particle) radiation differs from conventional electromagnetic radiation therapy. The use of protons (or helium ions) is produced by an accelerator (cyclotron, synchrotron, synchrocyclotron, or linear) and it allows particulate beams to pass through tissue and place ionizing energy at precise depths.

See medical policy hyperlink below

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 radiation using multiple beams at variable intensity.

Refer to MCG Care Guidelines for Intensity Modulated Radiation Therapy (IMRT)

POLICY

See also:  

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

Limited data is available to determine the efficacy of high-dose rate brachytherapy following a radical prostatectomy otherwise known as salvage therapy; therefore this radiotherapy is considered investigational.

SOURCES 

Agency for Healthcare Research and Quality. (2014) Therapies for clinically localized prostate cancer: update of a 2008 systematic review. Retrieved April 1, 2014 from: www.ahrq.gov.  

American College of Radiology / American Brachytherapy Society. (2015) Practice parameter for transperineal permanent brachytherapy of prostate cancer. Retrieved April 1, 2016 from: http://www.acr.org.  

American College of Radiology /American Society of Therapeutic Radiology and Oncology. (2010). ACR–ASTRO practice guideline for transperineal permanent brachytherapy of prostate cancer. Retrieved August 2, 2013 from http://www.acr.org/~/media/1AE76757ADA64E73812D316DDC8E4BCA.pdf.

American College of Radiology. (2013). ACR appropriateness criteria® high-dose-rate brachytherapy for prostate cancer. Retrieved April 7, 2015 from http://www.guideline.gov. (NGC: 010182).

American College of Radiology. (2013). ACR appropriateness criteria® definitive external beam irradiation in stage T1 and T2 prostate cancer. Retrieved April 7, 2015 from http://www.guideline.gov. (NGC: 010181).

American College of Radiology. (2014). ACR appropriateness criteria® postradical prostatectomy irradiation in prostate cancer. Retrieved April 7, 2015 from http://www.guideline.gov. (NGC: 010470).

American Society for Radiation Oncology / American Urological Association Education and Research. (2013) Adjuvant and salvage radiotherapy after prostatectomy: ASTRO/AUA guideline. Retrieved April 7, 2015 from http://www.guideline.gov. (NGC: 009907).

American Society of Therapeutic Radiology and Oncology/American Urological Association. (2013) Adjuvant and salvage therapy after prostatectomy: Astro/AUA guidelines. Retrieved August 2, 2013 from http://www.redjournal.org/webfiles/images/journals/rob/RAP%20Full%20Text%20Guideline%202nd%.

American Urological Association. (2011) Guideline for the management of clinically localized prostate cancer. Retrieved August 2, 2013 from http://www.guideline.gov.

BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2016). Brachytherapy for clinically localized prostate cancer using permanently implanted seeds (8.01.14). Retrieved February 3, 2017 from BlueWeb. (23 guidelines and /or articles reviewed)

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2015). High-dose rate temporary prostate brachytherapy. (8.01.33). Retrieved February 3, 2017 from BlueWeb. (20 guidelines and /or articles reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. LCD for stereotactic radiation therapy: stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) (L35076). Retrieved February 6, 2017 from https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35076&.

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).

Hurwitz, M., Halabi, S., Archer, L., McGinnis, L., Kuettel, M., DiBiase, S., et al. (2011). Combination external beam radiation and brachytherapy boost with androgen deprivation for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809. Cancer, 117 (24), 5579-5588. (Level 4 evidence - Independent study)

Jo, Y., Fujii, T., Hara, R., Yokoyama, T., Miyaji, Y., Yoden, E., et al. (2011, March). Salvage high-dose-rate brachytherapy for local prostate cancer recurrence after radiotherapy - preliminary results. BJU International. 109, 835-839. (Level 4 evidence)

Keyes, M., Crook, J., Morris, W. J., Morton, G., Pickles, T., Usmani, N., et al. (2013). Canadian prostate brachytherapy in 2012. Canadian Urologic Association Journal, 7 (1-2), 51- 58. (Level 5 evidence - Independent)

Lane, J., Donovan, J., Davis, M., Walsh, E., Dedman, D., Down, L., et al. (August, 2014). Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial. Lancet Oncology. 15, 1109-18. (Level 2 evidence)

Moghanaki, D., Turkbey, B., Vapiwala, N., Ehdaie, B., Frank, S., McLaughlin, P., et al. (2017). Advances in prostate cancer magnetic resonance imaging and positron emission tomography-computed tomography for staging and radiotherapy treatment planning. Seminars in Radiation Oncology, 27 (1), 21-33. Abstract retrieved February 6, 2017 from PubMed database.

National Cancer Institute. (2017). Prostate cancer treatment (PDQ®). Retrieved February 6, 2017 from https://www.cancer.gov/types/prostate/hp/prostate-treatment-pdq.

National Comprehensive Cancer Network. (2017). Clinical practice guidelines in oncology - version 1.2017: prostate cancer. Retrieved February 6, 2017 from the National Comprehensive Cancer Network.

National Institute for Health and Clinical Excellence. (2014, January). Prostate cancer, diagnosis and treatment. Retrieved April 7, 2015 from http://www.nice.org.uk/nicemedia/live/11924/39687/39687.pdf.

Skowronek, J. (2013). Low-dose-rate or high-dose-rate brachytherapy in treatment of prostate cancer - between options. Journal of Contemporary Brachytherapy, 5 (1), 33-41. (Level 5 evidence)

Traudt, K., Ciezki, J., & Klein, E. (2011). Low dose rate brachytherapy as salvage treatment of local prostate cancer recurrence after radical prostatectomy. Journal of Urology, 77 (6), 1416 - 1419. (Level 4 evidence - Independent study)

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.

Vanneste, B. G., Van Limbergen, E. J., van Lin, E. N., van Roermund, J. G., & Lambin, P. (2016). Prostate cancer radiation therapy: what do clinicians have to know? BioMed Research International, 2016, December 28, 1-19. (Level 5 evidence - Independent)

Wojcieszek, P, & Biatas, B. (2012). Prostate cancer brachytherapy: guidelines overview. Journal of Contemporary Brachytherapy, 4 (2), 116-120.

Yamada, Y., Kollmeier, M., Pei, X., Kan, C., Cohen, G., Donat, S, et al. (2013). Elsevier. A Phase II study of salvage high-dose-rate brachytherapy for the treatment of locally recurrent prostate cancer after definitive external beam radiotherapy.13 (2014) 111-116. (Level 4 evidence)

ORIGINAL EFFECTIVE DATE:  8/1983

MOST RECENT REVIEW DATE:  4/13/2017

ID_BT

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