Bridget Koontz, MD, on the rationale for the phase 2 NRG-GU011 trial

In this video, Bridget F. Koontz, MD, FASTRO, discusses the background and rationale for the phase 2 NRG-GU011 trial (NCT05053152), which is assessing the combination of relugolix plus stereotactic body radiation therapy (SBRT) vs SBRT alone. 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:

So, NRG-GU011, or the NRG PROMETHEAN trial, is a study that's supported by the NCI National Clinical Trials Network. It randomizes men who have had PSA recurrence [and] PSMA-PET which shows recurrence that is outside of the pelvis. It has to either be a bone metastasis or an extra pelvic nodal metastasis. It randomizes men to either SBRT radiation alone or radiation with 6 months of relugolix.

The rationale for this study was that before PSMA-PET, men would have biochemical recurrence, and if we could not find the source of disease, there was a discussion in radiation oncology clinics and in urology offices about, do we start hormone therapy now, or do we wait? There really wasn't a clear indication that one option was better than the other. There have been trials done in that space, and starting hormone therapy for metastatic disease is important, but all of those studies were done in the setting, pre-PET, in the bone scan, CT scan era. With PSMA, as we're detecting cancer at such an early stage, we really don't know that ADT is necessary to start immediate lifelong ADT at that time. So, this study is really getting at that question, could radiation target the lesions that we see on PET, and could we delay hormone therapy for men?

This transcription has been edited for clarity.