New prostate cancer trial seeks to reduce toxicity without sacrificing efficacy

The Alliance for Clinical Trials in Oncology has launched a randomized phase III clinical trial called RECIPROCAL (Alliance A032304) to explore whether doctors can optimize the timing of targeted radiation therapy to minimize side effects while preserving 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,” said Alliance study chair Thomas Hope, MD, a nuclear medicine physician and Professor in Residence at the University of California, San Francisco. “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.”

The current standard of care for men with metastatic castration-resistant prostate cancer includes Lutetium-177 Prostate Specific Membrane Antigen (PSMA) targeted Radioligand Therapy (RLT), a targeted radiation therapy attached to a drug molecule and injected into the bloodstream. Once in the body, PSMA RLT binds to cancer cells, killing them cells while minimizing harm to healthy tissue.

While PSMA RLT improves survival, it can cause side effects, such dry mouth, fatigue and gastrointestinal issues. Serious side effects can 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 falls, they will be randomized into one of two groups:

Standard Arm

• Participants receive up to four more PSMA RLT treatments every six weeks.

Adaptive Arm

• Participants have their PSA levels checked every 3 weeks. They will receive additional treatments only if their PSA increases or doctors see evidence of disease progression. At that point, patients will receive up to four more doses of PSMA RLT.

Follow‑Up 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,” said Deaglan McHugh, MD, the lead medical oncologist on the trial and Assistant Professor at Memorial Sloan Kettering Cancer Center. “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. Ultimately, we want men with advanced prostate cancer to not only live longer, but to also feel better during their treatment.”

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Reference: Alliance A032304/NCT07200830—Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

The Alliance for Clinical Trials in Oncology is a national leader in advancing cancer research, uniting more than 25,000 cancer specialists at 115 main institutions and 1,400 affiliate centers across the U.S. and Canada. As part of the National Clinical Trials Network and a leading research base for the NCI Community Oncology Research Program, the Alliance conducts pioneering, practice-changing clinical trials that improve outcomes and reshape standards of care. Our work has led to multiple FDA approvals, influenced national guidelines, and produced hundreds of high-impact publications. More than 40,000 participants have taken part in Alliance studies, and our growing biospecimen repository now includes more than 1.5 million samples, collected over the past 30 years. Learn more at www.AllianceforClinicalTrialsinOncology.org.

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