New study aims to improve both survival and quality of life for men with advanced prostate cancer

New study aims to improve both survival and quality of life for men with advanced prostate cancer

The Alliance for Clinical Trials in Oncology has launched a randomized phase III clinical trial called RECIPROCAL (Alliance A032304) to study whether doctors can optimize the timing of targeted radiation therapy to minimize side effects while maintaining effectiveness in men with advanced prostate cancer.

Our goal in this study is to strategically improve both survival and quality of life for men with advanced prostate cancer. We hope to demonstrate that we can safely tailor therapy to a person’s cancer, rather than sticking to a rigid schedule, maintaining the effectiveness of targeted radiation therapy while reducing side effects.”

Thomas Hope, MD,Allianz study director,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 includes targeted radioligand therapy (RLT) with lutetium-177 prostate-specific membrane antigen (PSMA), a targeted radiation therapy that is bound to a drug molecule and injected into the bloodstream. In the body, PSMA RLT binds to cancer cells, killing them while minimizing damage to healthy tissue.

While PSMA RLT improves survival rates, 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 study, clinicians will enroll approximately 1,500 participants. All participants will initially receive two infusions of PSMA RLT every six weeks. If a patient's PSA (prostate-specific antigen) level drops during this time, they will be randomized into one of two groups:

Standard arm

• Die Teilnehmer erhalten alle sechs Wochen bis zu vier weitere PSMA-RLT-Behandlungen.

Adaptive arm

• Die PSA-Werte der Teilnehmer werden alle 3 Wochen überprüft. Sie erhalten nur dann zusätzliche Behandlungen, wenn ihr PSA-Wert steigt oder die Ärzte Anzeichen für ein Fortschreiten der Krankheit erkennen. Zu diesem Zeitpunkt erhalten die Patienten bis zu vier weitere Dosen PSMA RLT.

Aftercare plan

• Nach Abschluss der Behandlung erhalten die Patienten alle 12 Wochen bis zum Fortschreiten der Krankheit eine Nachsorge, danach alle sechs Monate bis zu fünf Jahre nach der Aufnahme in die Studie.

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 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 treatment.”

Deaglan McHugh, MD, lead medical oncologist on the study and assistant professor at Memorial Sloan Kettering Cancer Center

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