The Alliance for Clinical Trials in Oncology plans to launch a clinical trial that will explore whether doctors can optimize the timing of radiation therapy for prostate cancer to minimize side effects while also maintaining treatment efficacy.
The phase III trial, called RECIPROCAL, will include 1,500 patients with metastatic, castration-resistant prostate cancer who will receive two infusions of lutetium-177 (Lu-177) prostate specific membrane antigen (PSMA) targeted radioligand therapy every six weeks. The therapy improves survival, but also can cause side effects such as dry mouth, fatigue, and gastrointestinal issues, as well as blood disorders, kidney damage, or liver problems.
"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," said study chair Thomas Hope, MD, of the University of California, San Francisco, in a statement released by the organization.
During the trial, if patients' PSA levels decrease, they will be randomized into one of two groups: A standard arm during which they will receive four more targeted radioligand treatments every six weeks, or an "adaptive arm" during which they will have their prostate-specific antigen (PSA) levels checked every three weeks. If these adaptive arm patients exhibit evidence of disease progression, they will be given up to four more doses of radioligand therapy. All study participants will receive follow-up care every 12 weeks until any evidence of disease progression appears, then every six months for up to five years after study enrollment.
"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," said Deaglan McHugh, MD, of Memorial Sloan Kettering Cancer Center in New York City, in the statement. McHugh is the trial's lead medical oncologist. "Ultimately, we want men with advanced prostate cancer to not only live longer, but to also feel better during their treatment."
