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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.
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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.
Early side effects and first results of radioligand therapy with 177Lu-DKFZ-617 PSMA of castrate-resistant metastatic prostate cancer: a two-centre study