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GU Cancers 2021 | STARTAR: one-year follow-up results

Tian Zhang, MD, Duke Cancer Center, Durham, NC, shares the latest data from the Phase II salvage STARTAR trial (NCT03311555) investigating androgen receptor inhibition with androgen deprivation therapy (ADT) and apalutamide with radiation therapy followed by docetaxel in men with PSA recurrent prostate cancer after radical prostatectomy. At 12 months of follow-up there have been no progression events and 38% of patients had post-treatment testosterone recovery into the normal range. The treatment was well tolerated in the majority of men with the exception of a high rate of drug rashes and neutropenia. This interview took place during the 2021 Genitourinary Cancers Symposium.

Transcript (edited for clarity)

So, STARTAR was a investigator initiated multi-center trial in biochemical recurrence in the salvage setting for high-risk prostate cancer. It’s premised on the fact that we know that radiation with hormone therapy and bicalutamide can improve disease-free survival outcomes for these men. And it enrolled over a course of about two years, 39 patients with high-risk prostate cancer. They were defined by PSA relapse within four years of prostatectomy with Gleason 8-10 disease or Gleason 7 disease with high-risk features, either T3 node-positive or positive margins and up to four positive lymph nodes at the time of prostatectomy...

So, STARTAR was a investigator initiated multi-center trial in biochemical recurrence in the salvage setting for high-risk prostate cancer. It’s premised on the fact that we know that radiation with hormone therapy and bicalutamide can improve disease-free survival outcomes for these men. And it enrolled over a course of about two years, 39 patients with high-risk prostate cancer. They were defined by PSA relapse within four years of prostatectomy with Gleason 8-10 disease or Gleason 7 disease with high-risk features, either T3 node-positive or positive margins and up to four positive lymph nodes at the time of prostatectomy.

All of these men were treated with hormone therapy as standard of care, as well as standard of care external beam radiation. We added apalutamide at the beginning of their treatments and then after their radiation was completed, they did up to six cycles of docetaxel chemotherapy. And they finished about nine months of treatment overall. And this was an interim analysis that we presented at GU ASCO, showing that with a follow-up of 14 months, there were zero PSA progression events, and 15 of these 39 patients had full testosterone recovery into the normal range.

So, it’s a really intensifying treatment upfront in this salvage setting and really trying to look for the three-year PSA recurrence rates, as well as testosterone recovery rates. So, early on we’re seeing that men are generally recovering their testosterone levels with no sign of PSA progression at around one year for the median follow-up.

The most common toxicities we did see, were hot flashes and fatigue as well as rashes from the apalutamide. More related from the docetaxel, we saw evidence of leukopenia, alopecia, and also neutropenia while they were on the docetaxel chemotherapy portion of the study. But they ultimately tolerated it pretty well and we were able to get men through pretty intensive treatment during the course of their salvage treatments.

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Disclosures

Tian Zhang, MD, has received research funding from Acerta, Novartis, Merrimack, Abbvie/StemCentrx, Merck, Regeneron, Mirati Therapeutics, Janssen, Astra Zeneca, Pfizer, OmniSeq, Personal Genome Diagnostics and Astellas; has been a speaker for Sanofi-Aventis and Genomic Health; has participated in advisory boards for Genentech/Roche, Merck, Exelixis, Sanofi-Aaventis, Janssen, Astra Zeneca, Pfizer, Amgen, BMS, Pharmacyclics, Seattle Genetics, Dendreon and Calithera; has done consultancy work for Bayer, Astra Zeneca, Foundation Medicine, IQVIA, MJH Associates, Pacific Genuity; and has familial connections to Nanorobotics, Capio Biosciences and Archimmune Therapeutics (spouse).

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