NCT03442075 - 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)

Attard G, Parker C, Eeles RA, Schröder F, Tomlins SA, Tannock I, Drake CG, de Bono JS
Prostate cancer. Lancet. 2016 Jan 2;387(10013):70-82. doi: 10.1016/S0140-6736(14)61947-4. Epub 2015 Jun 11. Review.
Herranz Amo F, Diéz Cordero JM, Cabello Benavente R
[Evolution of the transrectal ultrasound guided prostatic biopsy technique]. Arch Esp Urol. 2006 May;59(4):385-96. Review. Spanish.
Loeb S, Vellekoop A, Ahmed HU, Catto J, Emberton M, Nam R, Rosario DJ, Scattoni V, Lotan Y
Systematic review of complications of prostate biopsy. Eur Urol. 2013 Dec;64(6):876-92. doi: 10.1016/j.eururo.2013.05.049. Epub 2013 Jun 4. Review.
Lowrance WT, Roth BJ, Kirkby E, Murad MH, Cookson MS
Castration-Resistant Prostate Cancer: AUA Guideline Amendment 2015. J Urol. 2016 May;195(5):1444-52. doi: 10.1016/j.juro.2015.10.086. Epub 2015 Oct 20. Review.
Mottet N, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Schmid HP, van der Kwast T, Wiegel T, Zattoni F, Heidenreich A
[EAU guidelines on prostate cancer. Part II: treatment of advanced, relapsing, and castration-resistant prostate cancer]. Actas Urol Esp. 2011 Nov-Dec;35(10):565-79. doi: 10.1016/j.acuro.2011.03.011. Epub 2011 Jul 14. Spanish.
Sahin A, Ceylan C, Gazel E, Odabas Ö
Three different anesthesia techniques for a comfortable prostate biopsy. Urol Ann. 2015 Jul-Sep;7(3):339-44. doi: 10.4103/0974-7796.152014.

Prospective, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness of Four Analgesic Methods During Trans Rectal Prostate Biopsy.

Clinical trial NCT03442075 - References