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Treatment with five-fraction SBRT could be effective versus traditional radiation in certain patients with low- or intermediate-risk prostate cancer.
Stereotactic body radiotherapy (SBRT) compared with traditional radiation in patients with localized prostate cancer has been found to be noninferior, meaning it works just as well.
The phase 3 study, PACE-B, published in The New England Journal of Medicine determined that five-fraction SBRT may be an effective treatment option for patients with low- to intermediate-risk localized prostate cancer.
The study included 874 patients who were randomly assigned to two groups. The SBRT group included 433 patients and the control radiation group included 441 patients. All patients in the study either had low- or intermediate-risk localized prostate cancer.
Five-fraction SBRT: targeted radiation therapy that requires sessions across five days, delivered every other day.
Biochemical failure: when a lab test for prostate-specific antigen in prostate cancer shows a rise after treatment, which could mean the return of cancer.
Clinical failure: when the prostate cancer has worsened or spread after treatment, which may require more treatment.
"To be able to sit with a patient and say, 'We can treat you with a low toxicity treatment in five days, and your chance of keeping the cancer at bay for five years is 96%,' is a very positive conversation to have,” said lead study author Dr. Nicholas van As in a news release about the study. “We expect our trial to be practice-changing and people with intermediate-risk prostate cancer should be given the option of SBRT as an alternative to conventional radiation or prostate surgery.”
van As is a chief investigator professor, medical director and consultant clinical oncologist at The Royal Marsden NHS Foundation Trust and professor of precision prostate radiotherapy at The Institute of Cancer Research in London.
At a median follow-up of 74 months, 26 patients from the SBRT group experienced biochemical or clinical failure versus 36 patients in the traditional radiation group.
At five years, the rate of not having biochemical or clinical failure was 95.8% in the SBRT group and 94.6% in the traditional radiation group, the researchers stated. Of note, these percentages were achieved without the use of androgen deprivation (hormone) therapy, according to the study.
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“The results of the PACE-B trial … are a game-changer. They provide the most compelling level of data to date in support of prostate SBRT for early-stage disease, and directly inform the standard of care,” said Dr. Seth Blacksburg, chief medical officer of Accuray, in the news release. “This trial empowers men who require or prefer radiation treatment to utilize SBRT, a technique that not only offers highly effective cancer therapy but also significantly reduces the disruption to their lives compared to traditional schedules. This trial represents a crucial step forward in improving medical care and enhancing the quality of life for men diagnosed with prostate cancer.”
Accuray is the manufacturing company of the SBRT device used in the study.
Grade 2 or higher genitourinary side effects from radiation at five years were reported in 26 of the 355 patients who were treated with SBRT compared with 16 patients who received traditional radiation therapy. General grade 2 or higher genitourinary side effects occurred in 31 of 355 patients from the SBRT group versus 24 patients in the traditional radiation group, according to the study.
At five years, grade 2 or higher gastrointestinal side effects from radiation occurred in three patients who were treated with SBRT and in one patient treated with traditional radiation. Grade 2 or higher erectile dysfunction at five years occurred in 78 and 86 patients in the SBRT and traditional radiation groups, respectively.
Overall, 79 patients died in the study, with 46 from the SBRT group and 33 in the traditional radiation group. Four of these deaths were because of prostate cancer (two from each group). There were 28 deaths among patients which were because of other primary cancers, the researchers stated in the study.
Reference
“Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer” by Dr. Nicholas van As, et al., The New England Journal of Medicine.
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