Efficiently Performing Two Global Approval Studies In Prostate Cancer Patients
Prostate cancer is the second most frequent cancer diagnosis in men, and therapies to treat this disease are some of the most fiercely competitive in the oncology market.
Prostate cancer is the second most frequent malignancy (after lung cancer) in men worldwide, counting 1,276,106 new cases and causing 358,989 deaths (3.8% of all deaths caused by cancer in men) in 2018. The incidence and mortality of prostate cancer worldwide correlate with increasing age, with the average age at the time of diagnosis being 66 years. Although 2,293,818 new cases are estimated until 2040, a small variation in mortality will be observed (an increase of 1.05%). (Ferlay J EM, Lam F, Colombet M, Mery L, Pineros M, Znaor A, Soerjomataram I. et al. Global cancer observatory: cancer tomorrow. Lyon, France: International Agency for Research on Cancer)
Prostate cancer is also the fifth leading cause of death worldwide. Prostate cancer may be asymptomatic at the early stage and often has an indolent course that may require only active surveillance. Differences in the incidence rates worldwide reflect differences in the use of diagnostic testing. Prostate cancer incidence and mortality rates are strongly related to the age with the highest incidence being seen in elderly men > 65 years of age. (Prashanth Rawla. Epidemiology of Prostate Cancer. World J Oncol. 2019 Apr; 10(2): 63–89. PMID: 31068988, https://www.wjon.org/index.php/WJON/article/view/1191) Age-adjusted incidence rates of prostate cancer have increased dramatically and this is largely because of the increased availability of screening for prostate-specific antigen (PSA) in men without symptoms of the disease. This PSA test leads to detection of many prostate cancers that are small and/or would otherwise remain undiagnosed, and which may or may not develop further into higher stage disease. (https://www. wcrf.org/dietandcancer/prostate-cancer-statistics/)
A quickly growing biotech client approached QPS with a request to perform two Phase III trials in Prostate Cancer patients, designed to collect the efficacy, safety and pharmacokinetic information required to submit application for approval packages globally. The objective in mind was to conduct the studies and apply for global approvals in an expedited manner. QPS performed the duties of a central CRO, overseeing study conduct at all of the global clinical study sites across the USA, Europe and Asia. To get those studies started QPS was also involved in the development process of new formulation for an existing marketed product indicated for treatment of prostate cancer.
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