Prostate Specific Antigen Rapid Test

Zusammenfassung Die TITAN-Studie zum Vergleich von Apalutamid plus ADT mit Placebo plus ADT in einer breiten, sog.all-comers" Patientenpopulation mit metastasiertem hormonsensitivem Prostatakarzinom (mHSPC) erreichte bereits bei der ersten geplanten Interimsanalyse beide koprimaren Endpunkte rPFS und OS 1 . Nach einer medianen Nachbeobachtungszeit von 22,7 Monaten war das radiographische Progressionsrisiko um 52% statistisch signifikant reduziert (p<0,001) 1 . Dabei war der rPFS-Vorteil in allen Subgruppen und unabhangig von der Tumorlast oder einer Docetaxel-Vorbehandlung zu beobachten 1 . Die OS-Interimsanalyse zeigte statistisch signifikant ein um 33% verringertes Mortalitatsrisiko zugunsten von Apalutamid plus ADT (p=0,0053) 1 . Signifikant verbessert waren auch der sekundare Endpunkt Zeit bis zur zytotoxischen Chemotherapie (p<0,0001) sowie die explorativen Endpunkte Zeit bis zur PSA-Progression und PFS2, definiert als Zeit zwischen Randomisierung und der zweiten Progression bzw. Tod unter der ersten Folgetherapie 1 2 . Apalutamid wurde von den Patienten insgesamt gut vertragen. Neben einem erhohten Auftreten von Apalutamid-typischen Hautausschlagen und Hypothyreose wurde in TITAN im Vergleich zu Placebo keine relevante Zunahme anderer Nebenwirkungen von speziellem Interesse wie Fatigue, Sturze und Frakturen beobachtet, und auch die Lebensqualitat blieb erhalten 1 . Damit kann Apalutamid plus ADT bei einer All-comers-Population mit mHSPC eine effektive und gut vertragliche neue Therapieoption darstellen. Abstract The TITAN study, which compares apalutamide plus ADT with placebo plus ADT in an all-comers population of patients with metastatic hormone-sensitive prostate cancer (mHSPC), reached both primary endpoints, rPFS and OS, at the first planned interim analysis 1 . After a median follow-up of 22.7 months, the risk of radiographic progression was reduced by 52% (p<0.001) 1 . The rPFS benefit was observed in all subgroups and independently of tumour burden or docetaxel pre-treatment 1 . The OS interim analysis showed a mortality risk reduced by 33% in favour of apalutamide plus ADT (p=0.0053) 1 . The secondary endpoint of time to cytotoxic chemotherapy as well as the exploratory endpoints of time to PSA progression and second progression-free survival (PFS2), defined as time between randomisation and second disease progression or death under the first subsequent therapy, were also significantly improved 1 2 . Overall, apalutamide showed good tolerability, with a higher rate of apalutamide-typical rash and hypothyroidism but no relevant increase in fatigue, falls or fractures compared with placebo, and with quality of life being maintained 1 . Apalutamide plus ADT can thus be an effective and well-tolerated new treatment option in many patients with mHSPC.

Therapy response assessment is a critical step in cancer management, leading clinicians to optimize the use of therapeutic options during the course of the disease. Imaging is a pivotal biomarker for therapy response evaluation in oncology and has gained wider use through the development of reproducible data-based guidelines, of which the Response Evaluation Criteria in Solid Tumors is the most successful example. Disease-specific criteria have also been proposed, and the Prostate Cancer Working Group 3 criteria are the mainstay for prostate cancer (PC). However, conventional imaging evaluation in metastatic PC has several limitations, including (a) the inability to detect small-volume disease, (b) the high prevalence of bone (nonmeasurable) lesions at imaging, and (c) the established role of serum prostate-specific antigen (PSA) levels as the biomarker of choice for response assessment and disease progression. In addition, there are an increasing number of newer treatment options with various effects on imaging features. Prostate-specific membrane antigen (PSMA) PET has improved patient selection for newer treatments, such as metastasis-directed therapy (MDT) or radionuclide therapy. The role of PSMA PET in response assessment for many metastatic PC therapeutic options (MDT) androgen deprivation therapy, chemotherapy, radionuclide therapy, and immunotherapy) is an evolving issue, with emerging data showing good correlation with PSA levels and clinical outcome. However, there are specific implications of each therapy (especially androgen deprivation therapy and immunotherapy) on PSMA expression by PC cells, leading to potential pitfalls and inaccuracies that must be known by radiologists. Despite some limitations, PSMA PET is addressing gaps left by conventional imaging methods (eg, CT and bone scanning) and nonimaging biomarkers (PSA levels) in metastatic PC therapy response assessment, a role that can be improved with advances like refinement of interpretation criteria and whole-body tumor burden quantification. (C) RSNA, 2020