The NRG-GU011 trial, also known as the NRG PROMETHEAN trial, is currently enrolling participants to evaluate the efficacy of combining relugolix with stereotactic body radiation therapy (SBRT) versus SBRT alone in men with prostate-specific antigen (PSA) recurrence and prostate-specific membrane antigen (PSMA)-positive metastasis outside the pelvis. This Phase 2 study, supported by the NCI National Clinical Trials Network, seeks to determine if targeted radiation can delay or eliminate the need for immediate hormone therapy in this patient population.
Rationale for the Study
Prior to the advent of PSMA-PET imaging, clinicians faced uncertainty regarding when to initiate hormone therapy for men with biochemical recurrence but without a clear source of disease on conventional imaging. While hormone therapy is crucial for metastatic disease, studies supporting its early use were conducted before the PSMA-PET era. With PSMA-PET's ability to detect cancer at an earlier stage, the necessity of immediate, lifelong androgen deprivation therapy (ADT) is being questioned. NRG-GU011 aims to address whether radiation targeting PET-detected lesions, combined with relugolix, can offer a viable alternative to immediate ADT.
Trial Design and Patient Population
The trial randomizes men with PSA recurrence and PSMA-PET confirmed metastasis outside the pelvis (either bone or extra-pelvic nodal metastasis) to either SBRT alone or SBRT in conjunction with 6 months of relugolix. This design allows researchers to assess the potential of targeted radiation, augmented by short-term androgen deprivation, to control the disease and potentially delay or avoid long-term hormone therapy. Bridget F. Koontz, MD, FASTRO, highlights that the study is specifically designed to evaluate whether radiation can target lesions seen on PSMA-PET and potentially delay hormone therapy for men.
