Opinion

Video

Bridget Koontz, MD, highlights trials of radiation, hormone therapy in prostate cancer

Key Takeaways

  • The NRG-GU011 trial investigates relugolix plus SBRT versus SBRT alone in PET-oligometastatic prostate cancer.
  • ORIOLE and STOMP studies indicate SBRT can delay recurrence without early ADT in some patients.
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"The 5-year data from STOMP showed that about a third of men could go 5 years without requiring ADT, which is exciting," says Bridget F. Koontz, MD, FASTRO.

In this video, Bridget F. Koontz, MD, FASTRO, highlights the data supporting the ongoing phase 2 NRG-GU011 trial (NCT05053152), which is assessing the combination of relugolix plus stereotactic body radiation therapy (SBRT) vs SBRT alone in patients with PET-oligometastatic prostate cancer. The trial is currently seeking enrollment.

Koontz is radiation oncologist and the medical director of radiation oncology programs at AdventHealth Cancer Institute in Orlando, Florida.

Video Transcript:

First I'd like to highlight some studies that support the rationale for our 2 treatment arms. The first is that SBRT alone arm in the PSMA recurrence [subset]. That, of course, is the ORIOLE study (NCT02680587) and STOMP study (NCT01558427). Those studies randomized to SBRT alone or observation. The fact that observation is an option for these men highlights the equipoise that we don't know that they need ADT that early in their disease course. That both showed that SBRT, particularly when it was given to all areas of known metastasis, could delay additional recurrence. The 5-year data from STOMP showed that about a third of men could go 5 years without requiring ADT, which is exciting.

The other studies from a background standpoint are 2 studies that looked at whether or not you could give intermittent hormone therapy for metastatic disease. The one of course that I think folks remember is the SWOG-9346 trial (NCT00002651), which showed that intermittent therapy was not as beneficial treatment as continuous therapy. What people forget about is the is the Canadian NCI study, the PR07 study (NCT00002633). That was also a non-inferiority study looking at PSA rise in the pre-PET M0, non-metastatic space, so the exact space that we're looking at with this study. They actually found that delaying hormone therapy or intermittent hormone therapy was non-inferior to starting immediate hormone therapy. So, that's the rationale.

There are other studies that are open right now for patients in this PSMA recurrent space. That includes the ECOG-8191 or the INDICATE trial (NCT04423211), and that's a study that actually looks at the opposite question. That looks at hormone therapy alone, plus or minus radiation. I think those 2 studies together covers the gamut of treatment options for patients. The PI of INDICATE and I wrote those studies thinking of the other trial and hoping that we'll be able to compare results. Then the last one is for VA patients, and that's called the STARPORT trial (NCT04787744), and it's looking at the same 3 treatment options as well. So, [there are] a lot of studies that are out there and available, because this is a hot space that we don't know what the right answer is. So, we can do lots of different options, but we need to do them on a study so that we can understand and learn and make sure that the next time around, we're treating patients with better evidence data.

This transcription was AI generated and edited by human editors for clarity.

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