The Alliance for Clinical Trials in Oncology has launched a randomized phase III clinical trial called RECIPROCAL (Alliance A032304) to investigate whether doctors can optimize the timing of targeted radiation therapy to minimize side effects while maintaining efficacy in men with advanced prostate cancer.
Our goal in this trial is to strategically improve both survival and quality of life for men living with advanced prostate cancer. We hope to demonstrate that we can safely tailor treatment based on an individual’s cancer rather than sticking to a rigid schedule, thereby maintaining the effectiveness of targeted radiation therapy while reducing side effects.”
Thomas Hope, MD, Alliance Study Center, nuclear medicine physician and Professor in Residence, University of California, San Francisco
The current standard of care for men with metastatic castration-resistant prostate cancer involves targeted radioligand therapy (RLT) with prostate-specific antigen lutetium-177 (PSMA), a targeted radiation therapy that is attached to a drug molecule and injected into the bloodstream. Once inside the body, PSMA RLT binds to cancer cells, killing the cells while minimizing damage to healthy tissue.
While PSMA RLT improves survival, it can cause side effects such as dry mouth, fatigue, and gastrointestinal problems. Serious side effects may include blood disorders, kidney damage, or liver problems.
In the trial, clinicians will enroll about 1,500 participants. All participants will start by receiving two infusions of PSMA RLT every six weeks. During this time, if a patient’s prostate-specific antigen (PSA) level drops, they will be randomized to one of two groups:
Standard arm
- Participants receive up to four additional PSMA RLT treatments every six weeks.
Adjustable arm
- Participants have their PSA levels checked every 3 weeks. They will receive additional treatments only if their PSA rises or doctors see signs of disease progression. At that point, patients will receive up to four more doses of PSMA RLT.
monitoring schedule
- After completing treatment, patients will receive follow-up care every 12 weeks until disease progression, then every six months for up to five years after enrollment.
Our goal with RECIPROCAL is to show that treatment can be smarter, not just stronger. By tailoring treatment to each patient’s PSA response, we aim to reduce unnecessary toxicity and reduce side effects while providing the same survival benefit. Ultimately, we want men with advanced prostate cancer to not only live longer, but also feel better during their treatment.”
Deaglan McHugh, MD, lead medical oncologist on the trial and Assistant Professor at Memorial Sloan Kettering Cancer Center
