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American Journal of Nuclear Medicine and Molecular Imaging (1)
Research and Reports in Urology (1)
Poulsen, Mads Hvid (2)
Gerke, Oke (1)
Høilund-Carlsen, Poul Flemming (1)
Lund, Lars (1)
Svolgaard, Niels (1)
Vach, Werner (1)
Year of Publication
Prostate cancer: a review of active surveillance
Research and Reports in Urology
The objective of this paper is to review the current recommendations for active surveillance in prostate cancer from the present prospective studies. Worldwide, there are increasing numbers of men with prostate cancer. It is now accepted as standard care that a number of men with favorable-risk disease can be followed with active surveillance. In 1995, the first prospective studies were initiated to assess the feasibility of active surveillance, in which the decision to intervene was determined by prostate-specific antigen and/or histological progression. The strategy was to provide therapy individualized to the biological behavior of the cancer. Clinical trials assessing active surveillance have usually included patients younger than 70 years of age, although the guidelines have changed over time for Gleason score and prostate-specific antigen, eg, doubling time, thereby changing the indication for active treatment. The present review focuses on patient selection, prospective studies reported in the literature, and future directions.
active surveillance; prostate cancer; prospective studies; review
Interim analyses in diagnostic versus treatment studies: differences and similarities
Høilund-Carlsen, Poul Flemming
American Journal of Nuclear Medicine and Molecular Imaging
The purpose of this paper was to contrast interim analyses in (randomized controlled) treatment studies with interim analyses in paired diagnostic studies of accuracy with respect to planning and conduct. The term ‘treatment study’ refers to a (randomized) clinical trial that aims to demonstrate the superiority or noninferiority of one treatment compared with another, and the term ‘diagnostic study’ to a clinical study that compares two diagnostic procedures, using a third diagnostic procedure as the gold standard. Though interim analyses in treatment studies and paired diagnostic studies show similarities in a priori planning of timing, decision rules, and the consequences of the analyses, they differ with respect to (1) the need for sample size adjustments, (2) the possibility of early decisions without early stopping, and (3) the impact of keeping results secret. These differences are due, respectively, to certain characteristics of paired diagnostic studies: the dependence of the sample size on the agreement rate between the modalities, multiple aims of diagnostic accuracy studies, and the advantages of early unblinding of results at the individual level. We exemplified our points by using a recent investigation at our institution on the detection of bone metastases from prostate cancer in patients with histologically confirmed prostate cancer in which 99mTc-MDP whole body bone scintigraphy was compared to positron emission tomography/computed tomography with 18F-fluorocholine as tracer, using magnetic resonance imaging as a reference.
Study design; diagnostic imaging; PET/CT; efficacy studies; accuracy studies; sample size
Results 1-2 (2)
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