Clinical trials involving positron emission tomography and prostate cancer: an analysis of the ClinicalTrials.gov databa
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RESEARCH
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Clinical trials involving positron emission tomography and prostate cancer: an analysis of the ClinicalTrials.gov database Nikola Cihoric1*† , Eugenia Vlaskou Badra1†, Alexandros Tsikkinis1, Vikas Prasad2, Stephanie Kroeze5, Ivan Igrutinovic3, Branislav Jeremic4, Marcus Beck6, Sebastian Zschaeck6, Peter Wust6 and Pirus Ghadjar6
Abstract Background: The goal of this study is to evaluate the status and future perspectives of clinical trials on positron emission tomography in prostate cancer for diagnostic or therapeutic as well as for surveillance purposes. Methods: The www.ClinicalTrials.gov database was searched on the 20th of January 2017 for all trials containing terms describing “prostate cancer” (prostate, prostatic, malignant, malignancy, cancer, tumor) and “positron emission tomography”. In total 167 trials were identified. Trials that included diseases other than PCa were excluded (n = 27; 16%). Furthermore, we excluded trials (n = 4, 2%) withdrawn prior to first patient enrollment. The remaining trials (n = 137, 82%) were selected for further manual classification analysis. Results: One hundred thirty-seven trials were detected and analyzed. Majority of trials were in “active” recruitment status (n = 46, 34%) followed by trials that had been “completed” - (n = 34, 25%) and trials with “closed recruitment but active follow-up” (n = 23, 17%). Phase 1 and 2 comprised 46% of the complete trial portfolio. Locally confined disease was of major interest (n = 46, 34%), followed by metastatic disease – not otherwise specified (n = 43, 13%). Evaluation of PET was the primary goal of the trial in 114 (83%) cases. Most of the trials evaluated only one agent (n = 122, 89%). Choline and PSMA represented two major groups (total 50%) and they were equally distributed across trial portfolio with 25% (n = 34) each. PSMA trials showed the highest average annual growth rate of 56%. The trials were conducted in 17 countries. Conclusion: The scientific community is showing a strong and ever-growing interest in the field and we expect that in the coming years, more phase III trials will be initiated ultimately delivering the required Level 1 evidence. Keywords: Cancer of prostate, Cancer of the prostate, Neoplasms, prostate, Neoplasms, prostatic, Prostate cancer, Prostate neoplasms, Prostatic cancer, Positron emission tomography, Positron emission, Pet
Background Prostate cancer (PCa) represents the most common cancer in men and the third most common cause of cancer death [1]. Most newly diagnosed patients have localized PCa which can be effectively treated using a number of different treatment modalities [1]. Nevertheless, in the high-risk disease setting and in the presence of metastasis * Correspondence: [email protected] † Nikola Cihoric and Eugenia Vlaskou Badra contributed equally to this work. 1 Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010 Bern, Switzerland Full list of author information is available at the end of the
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