January 12 2022
NRG-GU011: A Phase II Double-Blinded, Placebo-Controlled Trial of Prostate Oligometastatic Radiotherapy with or without Androgen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG PROMETHEAN)
With the use of advanced imaging techniques, the incidence of radiographically detected oligometastatic prostate cancer has increased. The study of metastases shows that the spread of some prostate cancers is limited, with a few metastases originating from the primary prostate tumor. Castration or androgen deprivation therapy (ADT) typically serve as standard treatment for metastatic prostate cancer. This castrate state is often brought about through the use of gonadotropin release hormone analogs such as relugolix. However, recent studies have shown that in limited-volume metastatic disease, local therapy such as stereotactic ablative body radiation therapy (SABR), can have a significant effect on progression-free survival (PFS) and overall survival (OS) without requiring the use of ADT. The role of ADT in patents with serum prostate-specific antigen (PSA) recurrence or only PET-evident metastases continues to be questioned. National Comprehensive Cancer Network guidelines have endorsed either intermittent ADT or surveillance in PET-positive, 99mTc bone scan-negative patients. ADT is known to reduce quality of life (QoL) in patients and so avoiding, delaying, or reducing use of ADT provides patients with important options for care. However, the combination of ADT with non-SABR-based radiotherapy (RT) to the primary tumor site has shown, through NRG and other trials, to improve important outcomes such as cause-specific mortality and OS. Therefore, a study is needed which evaluates both tumor related outcomes (ie progression free survival) and quality of life outcomes for the treatment of oligometastatic prostate cancer with SABR, with or without ADT.
“A study such as NRG-GU011, which evaluates SABR alone and in combination with 6 months of relugolix, will provide value to determining the benefits and detriments of combination therapy in this new population of PET-detected oligometastatic disease,” stated Bridget Koontz, MD, of GenesisCare and the Principal Investigator of the NRG-GU011 study. She added, “Because relugolix is oral, and has been shown to promote a faster testosterone recovery when stopped, we are hypothesizing that we will see the synergistic benefit of combining radiotherapy and ADT without the long-term toxicity of ADT.”
NRG-GU011 is enrolling patients with a history of pathologically proven diagnosis of prostate adenocarcinoma and up to 5 metastases at any extra-pelvic nodal or bone anatomical location, along with a history of prior curative-intent treatment to the prostate. Once enrolled, all eligible patients will undergo radiotherapy to all metastases and will be randomly assigned to either receive a placebo (Arm 1) or relugolix (Arm 2) initiated concurrently with SABR.
The primary objective of NRG-GU011 is to compare conventional radiological progression-free survival (rPFS) for positron emission tomography (PET)-detected, biochemically recurrent, oligometastatic, castration-sensitive prostate cancer patients treated with SABR plus placebo vs. SABR plus relugolix. It is hypothesized that the addition of relugolix to SABR will improve rPFS.
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website