The Alliance for Clinical Trials in Oncology has initiated a significant phase III clinical trial named RECIPROCAL (Alliance A032304), aimed at improving both survival rates and quality of life for men diagnosed with advanced prostate cancer. The trial investigates the potential benefits of adjusting the timing of targeted radiation therapy to reduce side effects while maintaining treatment effectiveness.
According to Thomas Hope, MD, the study chair and a nuclear medicine physician at the University of California, San Francisco, the aim is to personalize therapy based on individual cancer responses rather than adhering to a fixed treatment schedule. “We hope to prove we can safely adjust the therapy based on an individual’s cancer instead of sticking to a rigid schedule, thus maintaining the effectiveness of targeted radiation therapy while reducing side effects,” he stated.
Current Treatment Landscape
The standard treatment for men suffering from metastatic castration-resistant prostate cancer currently includes Lutetium-177 Prostate Specific Membrane Antigen (PSMA) targeted Radioligand Therapy (RLT). This therapy involves administering a drug molecule linked to targeted radiation, which is injected into the bloodstream. Once inside the body, the PSMA RLT attaches to cancer cells, effectively destroying them while minimizing damage to healthy tissue.
Although PSMA RLT has been shown to enhance survival, it is not without its drawbacks. Common side effects include dry mouth, fatigue, and gastrointestinal issues, while more severe effects can encompass blood disorders, kidney damage, and liver complications.
Trial Design and Objectives
Approximately 1,500 participants will be enrolled in the RECIPROCAL trial. All participants will initially receive two infusions of PSMA RLT every six weeks. If a patient’s prostate-specific antigen (PSA) levels decrease, they will be randomly assigned to one of two groups: the standard arm or the adaptive arm.
In the standard arm, participants will receive up to four additional PSMA RLT treatments every six weeks, while in the adaptive arm, patients will have their PSA levels monitored every three weeks and will receive further treatments only if their PSA levels rise or if there is evidence of disease progression. This adaptive approach aims to tailor therapy to the patient’s specific condition.
Following the completion of treatment, patients will receive follow-up care every twelve weeks until disease progression, then every six months for up to five years.
Dr. Deaglan McHugh, the lead medical oncologist for the trial and an Assistant Professor at Memorial Sloan Kettering Cancer Center, emphasized the study’s innovative approach, stating, “Our goal with RECIPROCAL is to show that treatment can be smarter, not just stronger. 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 RECIPROCAL trial represents a promising advancement in the fight against advanced prostate cancer, with the potential to not only extend patients’ lives but also enhance their quality of life during treatment. As the trial progresses, it may pave the way for more personalized and effective cancer therapies in the future.
