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Real-World Evidence of Clinical Outcomes in Precision Radionuclide Oncology: The NIGHTCAP Study of 177Lu-PSMA in Metastatic Prostate Cancer

[ Vol. 26 , Issue. 31 ]

Author(s):

J. Harvey Turner*   Pages 3799 - 3803 ( 5 )

Abstract:


A novel approach to current radiopharmaceutical study design to document the efficiency of 177Lu- PSMA-radioligand therapy of metastatic prostate cancer is described in a proposed prospective, real-time, realworld audit of a large patient population worldwide. The NIGHTCAP (National Investigators Global Harmonisation Theragnostics of Cancer of Prostate) Study will establish real-world evidence (RWE) of overall survival (OS) and quality of life (QoL) in patients undergoing routine 177Lu-PSMA-radioligand therapy on harmonised compassionate patient-usage protocols throughout the world. Such long-term efficiency data will be contrasted with the short-term randomised controlled trial (RCT) assessments of efficacy predicated upon surrogate markers of survival outcomes, such as progression-free survival (PFS). The shortcomings of RCT evaluation of the clinical benefit of new anticancer agents are detailed in this review, which advocates RWE to determine efficiency.

The real-time monitoring of QoL in the NIGHTCAP Study is independent of questionnaires, language differences, or oncologist bias, and relies upon individual patient self-assessment by choice of one of five emoji which best reflects their mood each day.

Keywords:

Theragnostics, Real-world Data, efficiency, Lutetium-177-PSMA Radio-ligand Therapy, prostate cancer, NIGHTCAP Study.

Affiliation:

Medical School, Faculty of Health and Medical Sciences, The University of Western Australia, Crawley, WA 6009



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