NRG-GU011 (“NRG PROMETHEAN”) study of SABR with or without relugolix for PET-recurrent oligometastatic prostate cancer

September 15 2022

The standard of care for prostate cancer patients diagnosed as metastatic by conventional imaging is long-term androgen deprivation therapy. However, surveillance without ADT is an NCCN approved option for patients who have PET-detected metastatic disease who are not metastatic by bone scan or CT. This cohort of patients is similar to those who were M0 PSA recurrent prior to the availability of molecular imaging and thus can be treated with delayed ADT. For patients with PET-detected oligometastatic disease, stereotactic ablative body radiotherapy (SABR) without ADT may delay or prevent further disease progression in oligometastatic castration-sensitive prostate cancer. The STOMP trial evaluated SABR without systemic therapy with ADT withheld for conventionally detected metastases. They noted that at 2 years 45% of patients treated with SABR monotherapy were able to remain ADT free, and at 5 years 34% remained ADT (and conventional metastasis)-free. (Ost 2018; Ost 2020).

While delaying ADT may allow for better immediate quality of life and delay of the onset of castration refractory disease, combining ADT with radiotherapy for aggressive prostate cancer generally improves several key outcomes. Thus, a study evaluating SABR alone or in combination with ADT will provide value by determining the benefits and detriments of combination therapy in this new population of PET-detected oligometastatic disease. NRG GU-011, or NRG PROMETHEAN, is a double-blinded randomized trial of oligometastasis-directed radiotherapy with or without relugolix in men with castration-sensitive PET-detected oligometastatic cancer.

What are key eligibility?

  • Castration sensitive biochemically recurrent prostate cancer with PSA less than 10 ng/ml
  • Prior curative intent treatment to prostate with no evidence of local recurrence
  • Negative bone scan and pelvic CT or MRI
  • Positive fluciclovine or PSMA PET with up to 5 lesions in bone and/or nodal/soft tissue sites
  • Testosterone >/= 100 ng/dl within last 120 d

For more information and materials please visit the study page.

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