ESMO 2021: Health-Related Quality of Life, Pain and Safety Outcomes in the Phase 3 VISION Study of 177Lu-PSMA-617 in Patients with mCRPC

( The European Society of Medical Oncology (ESMO) 2021 annual meeting’s prostate cancer mini oral session included a presentation by Dr. Karim Fizazi discussing health-related quality of life, pain, and safety outcomes in the phase 3 VISION study. [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) delivers β-particle radiation to prostate-specific membrane antigen (PSMA) expressing cells and the surrounding microenvironment. In the phase III VISION study (NCT03511664), 177Lu-PSMA-617 + protocol-permitted standard of care prolonged radiographic progression-free survival (rPFS; HR 0.40, 99.2% CI 0.29-0.57), overall survival (OS; HR 0.62, 95% CI 0.52-0.74) and time to first symptomatic skeletal event (SSE, HR 0.50, 95% CI 0.40-0.62) versus standard of care (all p < 0.001) [1]. At the ESMO 2021 congress, Dr. Fizazi and colleagues presented health-related quality of life, pain assessments, and safety outcomes from VISION.

VISION was an international, open-label study of 177Lu-PSMA-617 in adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) previously treated with ≥ 1 androgen receptor pathway inhibitor and 1–2 taxane regimens. Patients were randomized 2:1 to 177Lu-PSMA-617 (7.4 GBq every 6 weeks, ≤ 6 cycles) plus standard of care or to standard of care alone. The trial design for VISION is as follows:

VISION study-0.jpg 

rPFS and OS were alternate primary endpoints, and time to SSE was a key secondary endpoint. Other secondary endpoints included safety and patient-reported health-related quality of life (Functional Assessment of Cancer Therapy – Prostate [FACT-P]) and pain (Brief Pain Inventory – Short Form [BPI-SF]). Pre-specified analyses included time to the first occurrence of health-related quality of life/pain worsening, disease progression or death.

 Health-related quality of life was assessed in the pre-specified rPFS analysis set comprising 581 of the 831 randomized patients (177Lu-PSMA-617 arm, n = 385; control arm, n = 196). Health-related quality of life and pain time-to-worsening analyses favored the 177Lu-PSMA-617 arm. For the FACT-P total score, time to worsening was 9.7 months for 177Lu-PSMA-617 compared to 2.4 months for standard of care alone (HR 0.46, 95% CI 0.35-0.61):

VISION study-1.jpg  

Additionally, for the BPI-SF pain intensity score, time to worsening was 14.3 months for 177Lu-PSMA-617 compared to 2.9 months for standard of care alone (HR 0.45, 95% CI 0.33-0.60):

VISION study-2.jpg 

A key secondary endpoint was time to first SSE, with a median time to SSE of 11.5 months for 177Lu-PSMA-617 and 6.8 months for standard of care (HR 0.50, 95% CI 0.40-0.62):

VISION study-3.jpg 

These outcomes were achieved by 177Lu-PSMA-617 despite a higher incidence of grade ≥ 3 adverse events versus standard of care alone. The most common grade 3-5 adverse events for 177Lu-PSMA-617 included bone marrow suppression (23.4%) and anemia (12.9%). There were no new or unexpected safety concerns noted, including changes in creatinine clearance. 

Dr. Fizazi concluded his presentation of health-related quality of life, pain, and safety outcomes from the VISION trial with the following-take home points:

  • The combination of 177Lu-PSMA-617 and standard of care in adults with mCRPC who were previously treated with androgen receptor pathway inhibitors and taxane chemotherapy extended overall survival, delayed radiographic progression-free survival, and was generally well-tolerated
  • Additionally, 177Lu-PSMA-617 plus standard of care delayed time to worsening in health-related quality of life and pain and delayed the time to first symptomatic skeletal event versus standard of care alone in adults with advanced mCRPC

Presented by: Karim Fizazi, MD, PhD, Head of the Department of Cancer Medicine at the Institut Gustave Roussy, Villejuif, France and Professor of Oncology at the University of Paris

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.


  1. Sartor O, de Bono J, Chi KN et al. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Jun 23 [Epub ahead of print].
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