A new phase III clinical trial, named RECIPROCAL (Alliance A032304), has been initiated by the Alliance for Clinical Trials in Oncology to investigate whether the timing of targeted radiation therapy can be optimized for men with advanced prostate cancer. The trial aims to improve both survival rates and the quality of life for these patients by minimizing side effects associated with treatment.
Thomas Hope, MD, the study chair and a nuclear medicine physician at the University of California, San Francisco, emphasized the trial’s goal: “We hope to prove we can safely adjust the therapy based on an individual’s cancer instead of sticking to a rigid schedule.” The aim is to maintain the effectiveness of targeted radiation therapy while reducing adverse effects.
Currently, the standard treatment for men with metastatic castration-resistant prostate cancer includes Lutetium-177 Prostate Specific Membrane Antigen (PSMA) targeted Radioligand Therapy (RLT). This therapy involves injecting a radioactive drug molecule into the bloodstream, where it targets and kills cancer cells while sparing healthy tissue. Despite its benefits in improving survival, PSMA RLT may lead to side effects such as dry mouth, fatigue, and gastrointestinal issues. More severe complications can include blood disorders, kidney damage, and liver problems.
Trial Structure and Objectives
The RECIPROCAL trial will enroll approximately 1,500 participants. Each participant will initially receive two infusions of PSMA RLT every six weeks. Following these treatments, if a patient’s prostate-specific antigen (PSA) level shows a decrease, they will be randomly assigned to one of two groups.
The first group, known as the standard arm, may receive up to four additional treatments of PSMA RLT every six weeks. Conversely, participants in the adaptive arm will have their PSA levels monitored every three weeks. Additional treatments for this group will only be administered if their PSA increases or there is evidence of disease progression. In those cases, patients will receive up to four more doses of PSMA RLT.
After completing the treatment, patients will undergo follow-up care every 12 weeks until the disease progresses, and subsequently every six months for up to five years post-enrollment.
Aiming for Smarter Treatment
The overarching goal of the RECIPROCAL trial is to demonstrate that treatment can be both effective and personalized. As Deaglan McHugh, MD, the lead medical oncologist on the trial and an Assistant Professor at Memorial Sloan Kettering Cancer Center, stated, “By tailoring therapy to each patient’s PSA response, we aim to reduce unnecessary toxicity and diminish side effects while still delivering the same survival benefit.”
The hope is that this innovative approach will allow men with advanced prostate cancer not only to live longer but also to enhance their overall experience during treatment. With ongoing advancements in cancer therapies, the RECIPROCAL trial represents a significant step towards more personalized and effective cancer care.
