Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate cancer
Treatment: Radiation therapy
The proposed radiation therapy is not medically necessary.

In this case, the patient is a male with a diagnosis of high-risk prostate cancer Gleason-7, and PSA of 40.3.  Definitive radiation therapy was recommended, and stereotactic body radiotherapy (SBRT) was requested.  However, based upon and in conclusion of this review, the proposed treatment is not considered medically necessary for this patient under these unique circumstances.
 
	
Stereotactic radiosurgery (SRS) is a highly precise form of radiation therapy used primarily to treat tumors and other abnormalities of the brain. The treatment involves the delivery of a single high-dose, or sometimes smaller, multiple doses, of radiation beams that converge on the specific area where the tumor or other abnormality resides.   It is a highly precise treatment, is able to minimize the amount of radiation to surrounding healthy and critical tissues.  Extracranial stereotactic body radiotherapy (SBRT) for certain conditions has also been shown to be safe and effective as compared to the standard radiation therapy.  Some of the conditions that have shown the most potential include spinal cord tumors and liver tumors.  There is also emerging data showing the potential of radiosurgery for the treatment of prostate cancer.  
		
SBRT is an FDA approved procedure and it is not subject to institutional board review (IRB) review.  In a 2008 study from Stanford University (1), a total of 41 patients with localized prostate cancer were treated with SBRT.  With a median follow-up of 33 months, the authors concluded that "the early and late toxicity profile and PSA response for prostate SBRT are highly encouraging, and continued accrual and follow-up will be necessary to confirm durable biochemical control rates and low toxicity profiles".  The American Society for Therapeutic Radiology and Oncology (ASTRO) recently reported that "It is ASTRO's opinion that data supporting the use of SBRT for prostate cancer have matured to a point where SBRT could be considered an appropriate alternative for select patients with LOW to INTERMEDIATE risk disease".  The National Comprehensive Cancer Network (NCCN) guidelines also supports its use stating that "Extremely hypofractionated image guided IMRT/SBRT regimens are an emerging treatment modality with single institutional and pooled reports of similar efficacy and toxicity to conventionally fractionated regimens.  They can be considered as a cautious alternative to conventionally fractionated regimens as clinics with appropriate technology, physics and clinical expertise", and that "SBRT combined with ADT, can be considered when delivering longer courses of EBRT would present a medical or social hardship".
						
In this case, the patient has a high risk prostate cancer with a Gleason score of seven and PSA of over 40.  Most of the published studies confirming the effectiveness of SBRT are for low-intermediate risk prostate cancer.  There are several ongoing trials still evaluating the role of SBRT for high risk prostate cancer.  The reference provided by AP (by Katz, et al) showed good potential of SBRT for high-risk prostate cancer, however, the number of high risk prostate cancer patients included in the trial was only 12. The other reference provided (from Lancet) concluded that "Ultra-hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy for intermediate-to-high risk prostate cancer regarding failure-free survival. Early side-effects are more pronounced with ultra-hypofractionation compared with conventional fractionation whereas late toxicity is similar in both treatment groups". There are several alternative options for the treatment of high risk prostate cancer including radical prostatectomy, intensity modulated radiation therapy (IMRT), brachytherapy, hormonal therapy or combined modality.  Although SBRT is a promising technology for high-risk prostate cancer, it is not a medically necessary treatment because there are many other established alternative options available for this patient.