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Hi, my name is Dr. Neeraj Agarwal. I'm a Professor of Medicine and Director of Genitourinary Oncology Program at the Huntsman Cancer Institute, University of Utah in Salt Lake City. Today I'm going to be discussing the application of androgen receptor pathway inhibitor in combination with radiation therapy for patients with high-risk localized non-metastatic prostate cancer who are undergoing radiation therapy.
As we know, in this setting, abiraterone has already been tested and showed improved survival outcomes. Since the study conducted by STAMPEDE investigators, and this one led by Dr. Ger Attard, was published in The Lancet 2 years ago and showed that adding abiraterone to androgen deprivation therapy plus radiation therapy in these patients improved survival outcomes.
Just to give you a background on this one, that previously docetaxel has been tested in this setting, but did not show improved survival outcomes. So in this trial, the STAMPEDE trial, newly diagnosed patients who had either node positivity, so local regional lymphadenopathy, or two of the following factors, which were a stage 3, so a stage T3 and T4 for prostate cancer by MRI, PSA of 40 ng/mL, or a Gleason score of 8, 9 or 10. So patients had to have two of these three or node positivity, were included. There was a small number of patients, 3% of patients had relapsing or recurring prostate cancer after prior radiation therapy or surgery. And these were also included but, in my view, data only applies to the newly diagnosed patients with high-risk localized non-metastatic prostate cancer. The median age was 68 years, median PSA was 34 ng/mL, and 39% of patients had lymph node enlargement, so quite a high-risk patient population. And we can see metastasis-free survival, which was the primary endpoint, was improved. The 6-year metastasis-free survival was improved from 69% to 82% in these patients, when - who received abiraterone. And this benefit was present across the subgroups regardless of the age, performance status, or lymph node status. If we look at the overall survival data, 6-year overall survival was improved by almost 10 points, from 77% to 86%.
So definitely these are practice-changing data. And these data have led to endorsement of abiraterone with prednisone as standard of care, in addition to androgen deprivation therapy with radiation therapy in patients with localized, high-risk, non-metastatic prostate cancer. So these patients receive radiation therapy plus 3 years of androgen deprivation therapy, and according to these data, should be receiving 2 years of abiraterone therapy.
There are two more trials which are ongoing, I would like to bring your attention to. In a very similar patient population where, instead of abiraterone, darolutamide and enzalutamide are being used respectively. So the first trial is DASL-HiCaP trial where 96 weeks, or roughly 2 years, of darolutamide is being used in addition to radiation therapy and androgen deprivation therapy. So 1,100 patients will be randomized to undergoing radiation therapy plus androgen deprivation therapy for their localized high-risk non metastatic prostate cancer, and half of them will be receiving darolutamide.
Similarly, in the ENZARAD trial, patients with high-risk, localized, non-metastatic prostate cancer who are undergoing radiation therapy with androgen deprivation therapy are being randomized to enzalutamide versus a conventional non-steroidal antiandrogen which is often bicalutamide.
So I really hope that some of these novel ARPIs will be approved and our patients will have more options in the setting beyond abiraterone.
I hope you found this video helpful for our patients and for our colleagues.
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