A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

NCT02825225 | Completed

• 1 other identifier: Prostate biopsy - 01
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose is to compare the detection rate of 20-core versus 12-core prostate biopsy. The secondary objective is to evaluate pain perception using a validated scale to compare the analgesia provided by the two different local anesthesia schemes. Data will be prospectively collected from patients who will undergo prostate biopsy in a single high volume urology center. The patients will be randomized to two different biopsy samplings and two local anesthesia schemes.

Conditions

Prostate Cancer; Local Anesthesia; Prostate-Specific Antigen/Blood; Biopsy/Methods; Image-guided Biopsy/Methods; Prostatic Neoplasms/Diagnosis; Prostate/Pathology; Prospective Studies; Humans; Male; Ultrasonography, Interventional/Methods

Keywords

Prostatic Neoplasms; Biopsy; Anesthesia; Detection

Outcome Measures

Primary Outcomes (1)

• Number of participants with prostate cancer detected.

  Statistical evaluation comparing detection of prostate cancer in 12-core versus 20 cores.

  Through study completion, an average of four years.

Secondary Outcomes (7)

• Number of participants with complications

  Immediate, early (30 minutes) and late (within first week)

• Core biopsy accuracy.

  Through study completion, at time of surgery.

• Pain perception using pain analogue scale.

  Immediate and early (30 minutes after biopsy).

• Number of participants with prostate cancer detected according to PSA value

  Through study completion, an average of four years.

• Number of participants with prostate cancer detected according to PSA density.

  Through study completion, an average of four years.

Study Arms (2)

20 core-biopsy fragments

EXPERIMENTAL

Patients submitted to experimental intervention (extended sextant biopsy with 20 cores) compared to current standard biopsy protocol (extended sextant biopsy with 12 cores) guided by transrectal ultrasound.

Other: 20 core-biopsy fragments; Procedure: Base and apex local anesthesia

Base and apex local anesthesia

EXPERIMENTAL

Patients submitted to experimental intervention in prostate-biopsy anesthetic protocol (prostate base and prostate apex bilateral local anesthetic injection) compared to participants submitted to current standard anesthetic protocol in institution (prostate base bilateral local anesthesia) guided by transrectal ultrasound. guided by transrectal ultrasound.

Other: 20 core-biopsy fragments; Procedure: Base and apex local anesthesia

Interventions

20 core-biopsy fragments OTHER

Using the extended sextant fashion prostate biopsy, this randomized group was submitted to a 20-fragments core-biopsy to evaluate the diagnostic power, pain perception and complications comparative to institution's standard 12 cores.

20 core-biopsy fragments; Base and apex local anesthesia

Base and apex local anesthesia PROCEDURE

Using the institution's standard local anesthesia protocol (base injection) as active comparator group, this randomized group was submitted to base and apex local anesthetic application to evaluate tolerability of the procedure, pain perception (with use of previous validated analogue pain scale) and complications.

20 core-biopsy fragments; Base and apex local anesthesia

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Formal indication to prostate biopsy: PSA elevation, positive digital rectal examination of prostate, prostate cancer active surveillance protocols.
• Patients signing the consent therm agreeing to participate in the trial
• Exclusive local anesthesia prostate biopsy.
• Exclusive transrectal ultrasound guided prostate biopsy.

You may not qualify if:

• Transperineal ultrasound guided prostate biopsy
• Magnetic resonance cognitive fusion biopsy.
• Previous treatment with radiation therapy or brachytherapy.
• Previous treatment with focal therapy
• Previous androgen deprivation therapy

Sponsors & Collaborators

• University of Nove de Julho: lead
• Hospital Brigadeiro UGA V-SP: collaborator

Study Sites (1)

Hospital Brigadeiro UGA V-SP

São Paulo, São Paulo, 01401-901, Brazil

Location

Related Publications (20)

• Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, Cooper D, Gansler T, Lerro C, Fedewa S, Lin C, Leach C, Cannady RS, Cho H, Scoppa S, Hachey M, Kirch R, Jemal A, Ward E. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012 Jul-Aug;62(4):220-41. doi: 10.3322/caac.21149. Epub 2012 Jun 14.

  PMID: 22700443 RESULT

• Giovannucci E, Liu Y, Platz EA, Stampfer MJ, Willett WC. Risk factors for prostate cancer incidence and progression in the health professionals follow-up study. Int J Cancer. 2007 Oct 1;121(7):1571-8. doi: 10.1002/ijc.22788.

  PMID: 17450530 RESULT

• Crawford ED. Epidemiology of prostate cancer. Urology. 2003 Dec 22;62(6 Suppl 1):3-12. doi: 10.1016/j.urology.2003.10.013.

  PMID: 14706503 RESULT

• Schroder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Paez A, Maattanen L, Bangma CH, Aus G, Carlsson S, Villers A, Rebillard X, van der Kwast T, Kujala PM, Blijenberg BG, Stenman UH, Huber A, Taari K, Hakama M, Moss SM, de Koning HJ, Auvinen A; ERSPC Investigators. Prostate-cancer mortality at 11 years of follow-up. N Engl J Med. 2012 Mar 15;366(11):981-90. doi: 10.1056/NEJMoa1113135.

  PMID: 22417251 RESULT

• Ross AE, Loeb S, Landis P, Partin AW, Epstein JI, Kettermann A, Feng Z, Carter HB, Walsh PC. Prostate-specific antigen kinetics during follow-up are an unreliable trigger for intervention in a prostate cancer surveillance program. J Clin Oncol. 2010 Jun 10;28(17):2810-6. doi: 10.1200/JCO.2009.25.7311. Epub 2010 May 3.

  PMID: 20439642 RESULT

• Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, Lieber MM, Cespedes RD, Atkins JN, Lippman SM, Carlin SM, Ryan A, Szczepanek CM, Crowley JJ, Coltman CA Jr. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003 Jul 17;349(3):215-24. doi: 10.1056/NEJMoa030660. Epub 2003 Jun 24.

  PMID: 12824459 RESULT

• Zisman A, Leibovici D, Kleinmann J, Siegel YI, Lindner A. The impact of prostate biopsy on patient well-being: a prospective study of pain, anxiety and erectile dysfunction. J Urol. 2001 Feb;165(2):445-54. doi: 10.1097/00005392-200102000-00023.

  PMID: 11176394 RESULT

• Nash PA, Bruce JE, Indudhara R, Shinohara K. Transrectal ultrasound guided prostatic nerve blockade eases systematic needle biopsy of the prostate. J Urol. 1996 Feb;155(2):607-9.

  PMID: 8558671 RESULT

• Rodriguez-Covarrubias F, Gonzalez-Ramirez A, Aguilar-Davidov B, Castillejos-Molina R, Sotomayor M, Feria-Bernal G. Extended sampling at first biopsy improves cancer detection rate: results of a prospective, randomized trial comparing 12 versus 18-core prostate biopsy. J Urol. 2011 Jun;185(6):2132-6. doi: 10.1016/j.juro.2011.02.010. Epub 2011 Apr 15.

  PMID: 21496851 RESULT

• Sfakianos JP, Thorner DA, Dovirak O, Weiss JP, Karanikolas NT. Optimizing prostate cancer detection during biopsy by standardizing the amount of tissue examined per core. BJU Int. 2011 Nov;108(10):1578-81. doi: 10.1111/j.1464-410X.2011.10239.x. Epub 2011 May 31.

  PMID: 21627750 RESULT

• 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. doi: 10.1097/01.ju.0000173924.83392.cc.

  PMID: 16145388 RESULT

• Zaytoun OM, Jones JS. Prostate cancer detection after a negative prostate biopsy: lessons learnt in the Cleveland Clinic experience. Int J Urol. 2011 Aug;18(8):557-68. doi: 10.1111/j.1442-2042.2011.02798.x. Epub 2011 Jun 21.

  PMID: 21692866 RESULT

• Ukimura O, Coleman JA, de la Taille A, Emberton M, Epstein JI, Freedland SJ, Giannarini G, Kibel AS, Montironi R, Ploussard G, Roobol MJ, Scattoni V, Jones JS. Contemporary role of systematic prostate biopsies: indications, techniques, and implications for patient care. Eur Urol. 2013 Feb;63(2):214-30. doi: 10.1016/j.eururo.2012.09.033. Epub 2012 Sep 25.

  PMID: 23021971 RESULT

• Pepe P, Aragona F. Saturation prostate needle biopsy and prostate cancer detection at initial and repeat evaluation. Urology. 2007 Dec;70(6):1131-5. doi: 10.1016/j.urology.2007.07.068.

  PMID: 18158033 RESULT

• Sonn GA, Natarajan S, Margolis DJ, MacAiran M, Lieu P, Huang J, Dorey FJ, Marks LS. Targeted biopsy in the detection of prostate cancer using an office based magnetic resonance ultrasound fusion device. J Urol. 2013 Jan;189(1):86-91. doi: 10.1016/j.juro.2012.08.095. Epub 2012 Nov 14.

  PMID: 23158413 RESULT

• King CR, McNeal JE, Gill H, Presti JC Jr. Extended prostate biopsy scheme improves reliability of Gleason grading: implications for radiotherapy patients. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):386-91. doi: 10.1016/j.ijrobp.2003.10.014.

  PMID: 15145152 RESULT

• Descazeaud A, Rubin M, Chemama S, Larre S, Salomon L, Allory Y, Vordos D, Hoznek A, Yiou R, Chopin D, Abbou C, de la Taille A. Saturation biopsy protocol enhances prediction of pT3 and surgical margin status on prostatectomy specimen. World J Urol. 2006 Dec;24(6):676-80. doi: 10.1007/s00345-006-0134-7. Epub 2006 Nov 7.

  PMID: 17089179 RESULT

• Marks LS, Fradet Y, Deras IL, Blase A, Mathis J, Aubin SM, Cancio AT, Desaulniers M, Ellis WJ, Rittenhouse H, Groskopf J. PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy. Urology. 2007 Mar;69(3):532-5. doi: 10.1016/j.urology.2006.12.014.

  PMID: 17382159 RESULT

• Leite KR, Tomiyama A, Reis ST, Sousa-Canavez JM, Sanudo A, Dall'Oglio MF, Camara-Lopes LH, Srougi M. MicroRNA-100 expression is independently related to biochemical recurrence of prostate cancer. J Urol. 2011 Mar;185(3):1118-22. doi: 10.1016/j.juro.2010.10.035. Epub 2011 Jan 21.

  PMID: 21255804 RESULT

• Leite KR, Sousa-Canavez JM, Reis ST, Tomiyama AH, Camara-Lopes LH, Sanudo A, Antunes AA, Srougi M. Change in expression of miR-let7c, miR-100, and miR-218 from high grade localized prostate cancer to metastasis. Urol Oncol. 2011 May-Jun;29(3):265-9. doi: 10.1016/j.urolonc.2009.02.002. Epub 2009 Apr 16.

  PMID: 19372056 RESULT

Related Links

• European society of Urology guidelines on prostate cancer

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Alkalies

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Jose Pontes Jr, MD PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 26, 2016
• First Posted: July 7, 2016
• Study Start: May 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 7, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)