TY - JOUR
T1 - Real-world evidence of clinical outcomes in precision radionuclide oncology
T2 - The nightcap study of177lu-psma in metastatic prostate cancer
AU - Harvey Turner, J.
PY - 2020
Y1 - 2020
N2 - A novel approach to current radiopharmaceutical study design to document the efficiency of177Lu-PSMA-radioligand therapy of metastatic prostate cancer is described in a proposed prospective, real-time, real-world audit of a large patient population worldwide. The NIGHTCAP (National Investigators Global Harmonisa-tion Theragnostics of Cancer of Prostate) Study will establish real-world evidence (RWE) of overall survival (OS) and quality of life (QoL) in patients undergoing routine177Lu-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 differ-ences, or oncologist bias, and relies upon individual patient self-assessment by choice of one of five emoji which best reflects their mood each day.
AB - A novel approach to current radiopharmaceutical study design to document the efficiency of177Lu-PSMA-radioligand therapy of metastatic prostate cancer is described in a proposed prospective, real-time, real-world audit of a large patient population worldwide. The NIGHTCAP (National Investigators Global Harmonisa-tion Theragnostics of Cancer of Prostate) Study will establish real-world evidence (RWE) of overall survival (OS) and quality of life (QoL) in patients undergoing routine177Lu-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 differ-ences, or oncologist bias, and relies upon individual patient self-assessment by choice of one of five emoji which best reflects their mood each day.
KW - Efficiency
KW - Lutetium-177-PSMA Radio-ligand Therapy
KW - Prostate Cancer
KW - Real-world Data
KW - Theragnostics
UR - http://www.scopus.com/inward/record.url?scp=85089625658&partnerID=8YFLogxK
U2 - 10.2174/1381612826666200312141347
DO - 10.2174/1381612826666200312141347
M3 - Review article
C2 - 32164507
AN - SCOPUS:85089625658
VL - 26
SP - 3799
EP - 3803
JO - Current Pharmaceutical Design
JF - Current Pharmaceutical Design
SN - 1381-6128
IS - 31
ER -