NCT01752140 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Djavan B, Margreiter M
Biopsy standards for detection of prostate cancer. World J Urol. 2007 Mar;25(1):11-7. Epub 2007 Mar 7. Review.
Lecuona A, Heyns CF
A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol. BJU Int. 2011 Jul;108(2):204-8. doi: 10.1111/j.1464-410X.2010.09887.x. Epub 2010 Nov 19.
Remzi M, Fong YK, Dobrovits M, Anagnostou T, Seitz C, Waldert M, Harik M, Marihart S, Marberger M, Djavan B
The Vienna nomogram: validation of a novel biopsy strategy defining the optimal number of cores based on patient age and total prostate volume. J Urol. 2005 Oct;174(4 Pt 1):1256-60; discussion 1260-1; author reply 1261.
Uzzo RG, Wei JT, Waldbaum RS, Perlmutter AP, Byrne JC, Vaughan ED Jr
The influence of prostate size on cancer detection. Urology. 1995 Dec;46(6):831-6.

A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme

Clinical trial NCT01752140 - References