ESMO 2021: Patient-Reported Outcomes in Prostate Cancer Patients Receiving PSMA-Targeted Radionuclide Therapy

( The European Society of Medical Oncology (ESMO) 2021 annual meeting’s prostate cancer session included a presentation by Dr. Brian Gonzalez discussing patient-reported outcomes in prostate cancer patients receiving prostate-specific membrane antigen (PSMA) radionuclide therapy. PSMA targeted radionuclide therapy is a promising investigational therapy for patients with progressive metastatic castration-resistant prostate cancer (mCRPC), conjugating a radionuclide emitting alpha radiation (e.g., Actinium-225) or beta radiation (e.g., Lutetium-177) to a small molecule ligand (e.g., PSMA-617) or a monoclonal antibody (e.g., J591) that has an affinity for PSMA. Treatment is generally well-tolerated, but adverse events have been reported. At the ESMO congress, Dr. Gonzalez and colleagues assessed patient-reported outcomes in prospective clinical trials.

From 2017 to 2021, 104 patients receiving either 177Lu-PSMA-617 or 225Ac-J591 with complete FACT-P and BPI instruments at baseline and 12 weeks later were included in the study. The authors used linear mixed model analyses with no imputation for missing data among participants with evaluable data to examine whether PROs changed over time and whether a change in PROs was associated with treatment received, baseline clinical factors, and response to treatment (i.e., best change in PSA after baseline).

Among patients included in the study, 91% receiving 177Lu-PSMA-617 and 100% receiving 225Ac-J591 experienced at least one adverse event, such as pain, fatigue, dry mouth, nausea, and hematologic toxicity. No overall change over time was observed in quality of life or pain, and treatment (i.e., 177Lu-PSMA-617 versus 225Ac-J591) was not associated with a change in PROs:



Baseline factors (e.g., ECOG performance status, metastases) were not associated with change over time in PROs. PSA decreased in 79% of participants (M = -64%, SD = 27%, range = -1% to -99%), and PSA increased in 21% of participants (M = 49%, SD = 65%, range = 1% to 233%). Response to treatment was associated with change over time in pain intensity, functional well-being, prostate-specific quality of life, and overall quality of life:


Dr. Gonzalez concluded his presentation of PROs for patients undergoing PSMA-radioligand therapy with the following take home messages:

  • This is the first study to compare change in PROs among patients receiving different targeted radionuclide therapy therapies
  • PROs did not change over time overall or as a function of PSMA targeted radionuclide therapy received; however, change in clinically important PROs was associated with response to treatment
  • Future studies should replicate and extend these findings to examine change in PROs as a potential prognostic factor for response to PSMA targeted radionuclide therapy.

Presented by: Brian D. Gonzalez, PhD, Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2021 European Society for Medical Oncology (ESMO) Annual Congress 2021, Thursday, Sep 16, 2021 – Tuesday, Sep 21, 2021.

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