A newly launched phase-III clinical trial hopes to answer one of the most important questions facing targeted radioligand therapy (RLT): How can doctors tailor the treatments to individual patients?
Called the RECIPROCAL trial, the study is seeking to enroll approximately 1,500 participants nationwide and is sponsored by the Alliance for Clinical Trials in Oncology. Study chair Thomas Hope, MD, of the University of California, San Francisco, recently explained that the goal is to explore whether doctors can optimize the timing of RLT (Pluvicto, Novartis) to minimize side effects while preserving efficacy in men with advanced prostate cancer.
“We hope to prove we can safely adjust the therapy based on an individual’s cancer instead of sticking to a rigid schedule,” Hope said.
In the trial, all participants will start by receiving two infusions of Pluvicto every six weeks. During this time, if a patient’s prostate-specific antigen (PSA) level falls, they will be randomized into one of two groups: either a standard arm or an adaptive arm.
In the standard arm, participants will receive up to four more treatments every six weeks. In the adaptive arm, they will have their PSA levels checked every three weeks and will receive up to four more doses only if their PSA increases or doctors see evidence of disease progression.
“Our goal with RECIPROCAL is to show that treatment can be smarter, not just stronger,” said Deaglan McHugh, MD, the lead medical oncologist on the trial and Assistant Professor at Memorial Sloan Kettering Cancer Center. The new study is partly modeled after the recently completed PSMAfore trial, he noted.
Hope added that ongoing efforts to bring Pluvicto and other RLT drugs up front in therapy need to consider the risk/benefit calculation.
More information about the RECIPROCAL trial can be found on the National Library of Medicine’s ClinicalTrials.gov website.