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MP 8.01.33 High-Dose Rate Temporary Prostate Brachytherapy
Medical Policy
Section
Therapy 		 Original Policy Date
4/30/00		 Last Review Status/Date
Reviewed with literature search/5:2009
Issue
5:2009		 Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

Description

Prostate brachytherapy can be delivered in a variety of ways. Perhaps the most familiar technique is the use of radioactive seeds permanently implanted into prostate tissue. These seeds contain isotopes that slowly emit radiation of relatively low energy. In contrast, temporary prostate brachytherapy involves use of higher energy radioisotopes such as iridium-192. These isotopes deliver radiation at higher dose rates, which may be more effective in destroying rapidly dividing cancer cells. In this technique, needle catheters are placed into the prostate gland using transrectal ultrasound guidance. Once the needles are placed, a dosimetric plan is developed and the radioactive source inserted into each needle using an afterloading device. The radioactive source is left in the needle for a predetermined time, called the “dwell” time. The radiation usually is delivered once or twice daily over a course of several days. The dwell time can be altered at various positions along the needle’s length to control dose distribution to the target volume and critical surrounding structures, such as the rectum or urethra. This strategy contrasts with permanent seed implantation in which dosimetry is calculated prior to needle placement and which cannot be altered after seed implantation. The treatment typically consists of 4,000 to 5,000 cGy delivered with external beam radiation therapy (EBRT) to the prostate and periprostatic tissues, while the high-dose rate brachytherapy (HDR BT) is used as the method of dose escalation to the prostate gland. The total boost doses are variable. In addition, studies are also being conducted using high-dose rate brachytherapy as the sole treatment modality (monotherapy) in those with prostate cancer.

It is an accepted premise that increasing doses of radiation therapy are associated with improved biochemical control (i.e., stable levels of prostate-specific antigen [PSA]), and thus there has been keen interest in exploring different techniques of dose escalation while simultaneously limiting both early and late toxicities in surrounding tissues. In patients with locally advanced disease, it is hypothesized that local failure may be related to the large volume of tumor and radioresistant cell clones, both of which might respond to higher radiation doses. High-dose rate prostate brachytherapy has been primarily investigated as an adjunct to external-beam radiotherapy (EBRT) as a technique of dose escalation. Other techniques for dose escalation include EBRT using intensity-modulated radiation therapy (IMRT) for treatment planning and delivery, proton beam radiotherapy (which may also use IMRT), or EBRT combined with brachytherapy using interstitial seeds.

Related policies:
8.01.14 – Brachytherapy for clinically localized prostate cancer using permanently implanted seeds.

Policy

High-dose rate prostate brachytherapy may be considered medically necessary as monotherapy or in conjunction with external beam radiation therapy in the treatment of localized prostate cancer.

High-dose rate prostate brachytherapy is considered investigational in the treatment of prostate cancer when used as salvage therapy.

Policy Guidelines

The CPT coding for high-dose rate prostate brachytherapy will consist of a series of CPT codes describing the treatment planning, dosimetry, and delivery of radiation therapy. These codes overlap with those describing brachytherapy using permanent seed implantation. However, since the therapy is given over a course of several days, the last 2 CPT codes listed below may be used more than once.

76873: Ultrasound, transrectal; prostate volume study for brachytherapy treatment planning

77326, 77327, 77328: Brachytherapy isodose calculation; simple, intermediate, or complex

77776, 77777, 77778: Interstitial radiation source application, simple, intermediate, or complex

77790: Supervision handling, loading of radiation source

The surgical code for placement of the brachytherapy catheter is:

55875: Transperineal placement of needles or catheters into prostate for interstitial radioelement application, with or without cystoscopy

Effective 1/1/09, there are new codes specific to afterloading of high-dose rate brachytherapy:

77785: Remote afterloading high dose rate radionuclide brachytherapy; 1 channel

77786: 2-12 channels

77787: over 12 channels

Benefit Application

BlueCard/National Account Issues

High-dose rate brachytherapy is not a widely disseminated procedure, and thus patients seeking this therapy may request access to an out-of-network facility.

Rationale

An evidence-based approach to the analysis of data on the various treatment options for prostate cancer is problematic for the following reasons:

  • The lack of controlled clinical trials comparing various different treatment options in homogeneous groups of patients. Thus far, the only randomized comparison of alternatives for managing early stage prostate cancer compared watchful waiting with radical prostatectomy. (1)
  • Similar trials are lacking to compare surgery with radiation or to compare different methods of radiation. In a recent review of 2,991 consecutive patients receiving a variety of therapies for localized prostate cancer, the authors concluded that it is still not possible to determine which of the treatment options leads to the best metastasis free or overall survival. Therefore, at the present time, there is no evidence-based gold standard of treatment, which limits the ability to assess emerging approaches. (2)
  • The numerous patient variables, including tumor stage, size of tumor (i.e., percent positive biopsy score), Gleason score, and PSA level.
  • The indolent natural history of many early stage prostate cancers, requiring prolonged follow-up to determine final patient outcomes.
  • A variety of intermediate outcomes have been used, most commonly biochemical failure as evidenced by rising PSA levels.
  • The evolving nature of radiation therapy. Over the last 10 years, there have been major advances in the planning and delivery of radiation therapy, including conformal therapy and intensity modulated radiation therapy (IMRT), both of which permit dose escalation. There are variables in the total dosage of radiation therapy, variations in the planning and delivery of radiation therapy, and multiple different combinations of therapy (i.e., EBRT plus brachytherapy). Fractionation of doses is another treatment variable that intends to balance the treatment effectiveness with both early and late morbidities to surrounding normal tissues.

 

  • The role of dose escalation in radiation therapy of prostate cancer. A dose-response relationship in the treatment of prostate cancer is generally accepted among clinicians and physicists, and in fact serves as the scientific rationale of high-dose rate brachytherapy, as well as other recent techniques for radiation planning and delivery (i.e., IMRT). While a few randomized controlled trials have examined this issue, the data suggest that dose escalation is associated with improved biochemical control. (3) However, data regarding the impact of total radiation dose on survival among patients with different prognostic factors are minimal. In addition, the optimal radiation therapy dose is unknown. (4)

 

Given these significant limitations, the following results have been reported for high-dose rate (HDR) as an adjunct to external beam radiation therapy (EBRT). The largest case series has been reported by researchers at the William Beaumont Hospital in Royal Oak, Michigan. This group reported on the outcomes of a series of 207 patients treated between 1991 and 2000. (5) All patients had poor prognostic factors, which included tumor stage T2B, a Gleason score of 7, or a PSA greater than 10 nl/mL. External beam radiation therapy was alternated with HDR radiation therapy as a boost. At a mean follow-up of 4.7 years, overall biochemical control rate was 74%, but was 85% if one poor prognostic factor was present, 75% if 2 were present, and 50% if all 3 were present. Late toxicity was minimal. The authors suggest that these results are similar or better to other treatment alternatives for prostate cancer with poor prognostic features. In another analysis, the authors performed a matched-pair analysis of HDR brachytherapy boost versus EBRT alone. (6) A total of 161 patients received a HDR boost; they were randomly matched with a unique patient who received EBRT alone. Patients were matched according to PSA level, Gleason score, T stage, and follow-up of duration. Those who received the HDR boost reported a 5-year biochemical control rate of 67% compared to 44% in those receiving EBRT alone. In a review article, Vicini and colleagues summarized the experience reported in 8 other case series of locally advanced prostate cancer totaling just over 1,000 patients. (7) The biochemical control rate ranged from 74% to 97% with median follow-ups ranging from 11 to 74 months.

An update of the related policy No. 8.01.14 on conventional brachytherapy (using permanently implanted seeds) noted that while final health outcomes are not available, thus limiting scientific conclusions, conventional brachytherapy had become widely accepted by patients and physicians and may be considered a reasonable treatment option. Large case series of conventional brachytherapy have reported data on both morbidity and the intermediate outcome of biochemical relapse-free survival (i.e., survival-free from increasing PSA levels). These studies show that conventional brachytherapy is associated with similar outcomes when compared with the alternative (EBRT). Therefore, given the uncertainty for choosing between the established treatment options of watchful waiting, radical prostatectomy, EBRT, or conventional brachytherapy, some may consider patient preference to be particularly appropriate in selecting conventional brachytherapy.

2005 Update

A review of the literature for the period of 2004 through April 2005 did not identify any additional literature that would address the limitations noted above. An international group of investigators reported on the use of HDR as an adjunct to EBRT with or without androgen-deprivation therapy in a case series of 611 patients. (8) A total of 209 patients were treated at William Beaumont Hospital, and thus it is likely that there are overlapping patients with the studies reviewed above. While the authors reported that adjunctive HDR was associated with excellent long-term outcomes in terms of biochemical control, disease-free survival and cause-specific survival, interpretation of the findings is extremely limited due to the absence of a control group.

2006 Update

A review of the literature for the period of April 2005 through June 2006 again did not identify literature that would address the limitations noted above. Investigators from the Endocurietherapy Cancer Center reported on outcomes (median follow-up of 7.25 years) of 209 consecutive patients with localized prostate cancer treated with high-dose rate brachytherapy combined with external-beam radiotherapy. (9) The PSA progression-free survival rate was 90%, 87%, and 69% for the low-, intermediate-, and high-risk groups, respectively.

2007 Update

A literature review was conducted using MEDLINE through June 2007. Hoskin and colleagues reported on a European single-center randomized trial of 220 patients conducted between 1997 and 2005 where EBRT was compared to EBRT with HDR brachytherapy. (10) With a median follow-up of 30 months, the authors noted an improvement in actuarial biochemical relapse-free survival as well as a lower incidence of acute rectal discharge. However, the total dose delivered in this study was about 55 Gy, substantially below the 70 Gy does typically delivered by EBRT using conformal techniques. Thus, the applicability of these findings at typical radiation doses is uncertain. Phan reported on a case-series of 309 patients treated with EBRT (40 to 45 Gy) and HDR brachytherapy (22 to 24 Gy). (11) At a median follow-up of 59 months, the 5-year biochemical control rate was 86% and overall survival was 91%; rates were higher for those with lower-risk disease. However, these results cannot be interpreted without having a comparable control group.

Some studies have also been conducted using HDR brachytherapy as the sole treatment modality in those with prostate cancer. However, as noted in a review article, longer follow-up and more published data are needed to show the comparative efficacy and safety of this approach. (12) Results from published series are limited by the number of patients studied, the length of follow-up, and/or lack of a comparable control group. (13-15) Questions have also been asked about patient acceptance of high-dose compared to low-dose brachytherapy.

The National Cooperative Cancer Network (NCCN) guidelines for treatment of prostate cancer do not include recommendations on use of HDR brachytherapy. (16)

2008 - 2009 Update
The policy was updated with a literature review using MEDLINE in April 2009. Hurwitz reviewed both low-dose and high-dose (HDR) brachytherapy combined with external beam radiation therapy (EBRT) in the treatment of prostate cancer. (17) The review notes that single-institution experience shows promise. This review comments on the study by Hoskin (10) and notes that concerns about administration of the EBRT may hinder extrapolation of the results to current practice. The review also notes that there are no reported studies that directly compare outcomes of treatment with currently available EBRT techniques that allow dose escalation to those with dose escalation using HDR.

Publications on use of HDR as monotherapy for treatment of prostate cancer are fewer than those that report its use as combined modality therapy with EBRT. The largest published series of this modality are results of a phase II study by Corner et al. (18) This study involved 110 patients treated with 3 regimens: 34 Gy in four fractions, 36 Gy in four fractions, and 31.5 Gy in three fractions. At 6 months, 2 patients had grade 3 bladder toxicity, and one patient had grade 2 gastrointestinal (GI) toxicity. No PSA relapses have been detected, although the median follow-up was just 12 months among the 55 patients that received 31.5 Gy. The authors concluded that these early results suggest an excellent biochemical response with no differences seen in acute and late toxicity between the 3 regimens. Grills and colleagues reported on a series of 149 patients with early stage prostate cancer who were treated with either permanent or temporary (HDR) brachytherapy at one center. (19) In this series, patients selected which of the 2 treatments they would receive. Treatments were given between 1999 and 2001. The authors note lower acute grade 1 to 3 symptoms in the HDR group, but many of these symptoms were grade 1. The reported rates of grade 2 and 4 chronic genitourinary (GU) toxicity did not vary and were 23%. The impotence rate was 16% in the HDR group and 45% in the LDR group. Levels of biochemical control were similar in the 2 groups with median follow-up of 35 months. Given the non-random assignment of patients in this single institution study, additional confirmatory trials may be useful.

Material from clinical input (see below) indicates that results of larger trials (n of about 100 and 300) of HDR brachytherapy as monotherapy have been presented at national meetings, but not yet published.

Data on using HDR in the salvage treatment following failed prior radiation therapy remain limited. Review of active studies through clinicaltrials.gov indicates a number of active studies related to use of HDR as both monotherapy and as salvage therapy.

Physician Specialty Society and Academic Medical Center Input
In response to requests, input was received from 2 physician specialty societies (4 reviews) and 2 academic medical centers while this policy was under review for March 2009. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted. There was generally strong support for use of HDR (as monotherapy and with EBRT) as an option in the treatment of prostate cancer.

In summary, based on the data from published studies, the clinical input, and the view of many that HDR be viewed as another type of radiation therapy, its use may be considered medically necessary combined with external beam radiation therapy in the treatment of patients with localized prostate cancer. While data are much more limited on its use as monotherapy, given what is known about temporary and permanent brachytherapy, this may also be considered an option as monotherapy based on existing data and clinical input.

Because published data are still limited and clinical trials are ongoing, use of HDR in the treatment of prostate cancer as salvage therapy is considered investigational.

 

 

References:

  1. Holmberg L, Bill-Axelson A, Helgesen F et al. A randomized trial comparing radical prostatectomy with watchful waiting in early prostate cancer. N Engl J Med 2002; 347(11):781-9.
  2. Kupelian PA, Potters L, Khuntia D et al. Radical prostatectomy, external beam radiotherapy or = 72 Gy, permanent seed implantation, or combined seeds/external beam radiotherapy for stage T1-T2 prostate cancer. Int J Radiat Oncol Biol Phys 2004; 58(1):25-33.
  3. Pollack A, Zagars GK, Starkschall G et al. Prostate cancer radiation dose response: results of the MD Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys 2002; 53(5):1097-105.
  4. Vicini FA, Abner A, Baglan KL et al. Defining a dose-response relationship with radiotherapy for prostate cancer: is more really better? Int J Radiat Oncol Biol Phys 2001; 51(5):1200-8.
  5. Martinez A. Gonzalez J, Spencer W et al. Conformal high dose rate brachytherapy improves biochemical control and causes specific survival in patients with prostate cancer and poor prognostic factors. J Urol 2003; 169(3):974-80.
  6. Kestin LL, Martinez AA, Stromberg JS et al. Matched-pair analysis of conformal high-dose-rate brachytherapy boost versus external-beam radiation therapy alone for locally advanced prostate cancer. J Clin Oncol 2000; 18(15):2869-80.
  7. Vicini FA, Vargas C, Edmundson G et al. The role of high dose rate brachytherapy in locally advanced prostate cancer. Semin Radiat Oncol 2003; 13(2):98-108.
  8. Galale RM, Martinez A, Mate T et al. Long-term outcome by risk factors using conformal high-dose-rate brachytherapy (HDR-BT) boost with or without neoadjuvant androgen suppression for localized prostate cancer. Int J Radiat Oncol Biol Phys 2004; 58(4):1048-55.
  9. Demanes DJ, Rodriguez RR, Schour L et al. High-dose-rate intensity-modulated brachytherapy with external beam radiotherapy for prostate cancer: California endocurietherapy’s 10-year results. Int J Radiat Oncol Biol Phys 2005; 61(5):1306-16.
  10. Hoskin PJ, Motohashi K, Bownes P et al. High dose rate brachytherapy in combination with external beam radiotherapy in the radical treatment of prostate cancer: initial results of a randomised phase three trial. Radiother Oncol 2007; [e-pub ahead of print].
  11. Phan TP, Syed AM, Puthawala A et al. High dose rate brachytherapy as a boost for the treatment of localized prostate cancer. J Urol 2007; 177(1):123-7.
  12. Stock RG. High-dose-rate versus low-dose-rate monotherapy in the treatment of localized prostate cancer: the case for low-dose-rate monotherapy. Brachytherapy 2006; 5(1):5-6.
  13. Grills IS, Martinez AA, Hollander M et al. High dose rate brachytherapy as prostate cancer monotherapy reduces toxicity compared to low dose rate palladium seeds. J Urol 2004; 171(3):1098-104.
  14. Yoshioka Y, Konishi K, Oh RJ et al. High-dose-rate brachytherapy without external beam irradiation for locally advanced prostate cancer. Radiother Oncol 2006; 80(1):62-8.
  15. Oh RJ, Yoshioka Y, Tanaka E et al. High-dose-rate brachytherapy combined with long-term hormonal therapy for high-risk prostate cancer: results of a retrospective analysis. Radiat Med 2006; 24(1):58-64.
  16. National Cooperative Cancer Network. Prostate cancer. Clinical Practice Guidelines in Oncology, v.2.2007. Available at www.nccn.org/professionals/physician_gls/PDF/prostate.pdf (Last accessed July 23, 2007).
  17. Hurwitz MD. Technology Insight: combined external-beam radiation therapy and brachytherapy in the management of prostate cancer. Nat Clin Pract Oncol 2008; 5(11):668-76.
  18. Corner C, Rojas AM, Bryant L et al. A phase II study of high-dose rate afterloading brachytherapy as monotherapy for the treatment of localized prostate cancer. Int J Radiat Oncol Biol Phys 2008; 72(2): 441-6.
  19. Grills IS, Martinez AA, Hollander M et al. High dose rate brachytherapy as prostate cancer monotherapy reduces toxicity compared to low dose rate palladium seeds. J Urol 2004; 171(3):1098-104.

 

Codes

Number

Description
CPT 55875 Transperineal placement of needles or catheters into prostate for interstitial radioelement application, with or without cystoscopy
76873  Echography, transrectal; prostate volume study for brachytherapy treatment planning 
  77326, 77327, 77328  Brachytherapy isodose calculation; simple, intermediate, or complex 
  77776, 77777, 77778  Interstitial radioelement application, simple, intermediate, or complex 
  77790  Supervision handling, loading of radioelement 
ICD-9 Procedure  92.27  Implantation or insertion of radioactive elements 
ICD-9 Diagnosis  185  Malignant neoplasm of prostate 
HCPCS  C1717  Brachytherapy source, high dose rate iridium 192, per source 
  Q3001  Radioelements for brachytherapy, any type, each 
Type of Service  Therapy 
Place of Service  Outpatient 

Index

Brachytherapy, High-Dose Rate, Prostate Cancer
High-Dose Rate Brachytherapy, Prostate Cancer
Prostate Cancer, High-Dose Rate Brachytherapy  

Policy History

Date Action Reason
04/30/00 Add to Therapy section New policy
12/18/02 Replace policy Policy updated; policy statement unchanged
07/15/04 Replace policy Policy updated; policy statement unchanged, references added, Rationale revised
06/27/05 Replace policy Policy updated with literature search; policy statement unchanged; reference number 8 added
07/20/06 Replace policy. Policy updated with literature search; policy statement unchanged. Reference 9 added. HCPCS coding updated.
08/02/07 Replace policy Policy updated with literature search; remains investigational. Policy statement modified to indicate high-dose rate prostate brachytherapy considered investigational for dose escalation or as sole therapy. Reference numbers 10 to 16 added
05/14/09 Replace policy Policy updated with literature search; reference numbers 17 – 19 added; clinical input reviewed. Policy revised to indicate that HDR may be considered medically necessary as monotherapy and when combined with EBRT in the treatment of prostate cancer. Remains investigational as salvage therapy. CPT coding updated.

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