Prostate CancerNCT02825225
A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes
A study testing 20 core-biopsy fragments and Base and apex local anesthesia in people with Prostate Cancer and Local Anesthesia, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Prostate Cancer, Local Anesthesia, Prostate-Specific Antigen/Blood
- What is being tested?
- 20 core-biopsy fragments and Base and apex local anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial To Assess and Compare the Outcomes of 20-core Versus 12-core Prostate Biopsy
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.
Read the detailed description
Prostate cancer is male's leading solid non-cutaneous tumor, and the second cause of cancer death in western countries. The main risk factors are age (5th decade or more), family history and life-style (low physical activity and occidental dietary habit). Due to it's high incidence and mortality, the screening protocols continue to be supported worldwide by the urologic and oncologic societies. The diagnosis of this disease needs histological evidence that is obtained by prostate biopsy which is indicated when prostate specific antigen (PSA) serum levels are elevated or there is suspicion at digital rectal examination. Actual estimations conclude that more than 200.000 new cases are diagnosed per-year in US and much more patients are submitted to biopsies; turning prostate biopsy a routine medical procedure. In therms of current medical evidence there is controversy in some biopsy aspects. The ideal number of fragments to be obtained is not well established. While twelve core is believed to be the minimum to be sampled, the maximum number is not clear. To ease the estimation of the number of necessary core at biopsy the literature recommend the use of nomograms; they adequate the number of removed fragments according to each individual characteristics such as age, volume, previous biopsy and PSA levels. The prostate biopsy is considered a painful procedure by 96% of patients, therefore it is fundamental to soften the soreness employing some form of anesthesia. There is no consensus regarding the ideal protocol but the local anesthesia with the periprostatic blockade is the most employed worldwide. However there is a controversy related to the site of the injection during the periprostatic block in terms of efficacy: base versus apex or both sites.
Considering the epidemiological importance of prostate cancer detection in a continuous aging population, this study protocol was enrolled in a single center high volume urology Brazilian Public Hospital. The patients will be randomized at a 1:1 ratio for the two biopsy schemes and for the two anesthesia templates.The main objective was to compare the detection rate of two different prostate biopsy schemes 20-core versus 12-core prostate biopsy guided by transrectal ultrasound. Secondary objectives were to evaluate pain perception of the two local anesthesia schemes using a validated pain scale. The pain was evaluated using the visual pain scale immediately after the biopsy and one hour after the procedure. The patients were contacted by phone one week after the biopsy to assess the occurrence of any complication. The investigators then compared the major and minor complication rates of 20-core versus 12-core protocol using the Clavien-Dindo scale. In those patients with cancer at the pathologic report that underwent radical prostatectomy, the investigators will also compare the concordance of Gleason score between the biopsy versus surgical specimen according to the biopsy scheme 20-core versus 12-core.
Data was collected since mid 2012 up to june 2016, inclusion and exclusion criteria will be detailed elsewhere. All information was obtained by the main investigator and all procedures were supervised by the main investigator as well.
- Conditions
- Prostate Cancer, Local Anesthesia, Prostate-Specific Antigen/Blood, Biopsy/Methods, Image-guided Biopsy/Methods, Prostatic Neoplasms/Diagnosis
- Being tested
- 20 core-biopsy fragments, Base and apex local anesthesia
- Keywords
- Prostatic Neoplasms, Biopsy, Anesthesia, Detection
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 core-biopsy fragmentsOther
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.
Base and apex local anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 20 core-biopsy fragments; Procedure: Base and apex local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with prostate cancer detected.
Statistical evaluation comparing detection of prostate cancer in 12-core versus 20 cores.
Measured: Through study completion, an average of four years.
Secondary outcomes (7)
Number of participants with complications
Comparison of data between 12 versus 20 core-biopsy and base versus base plus apex anesthesia in therms of complication occurrence.
Measured: Immediate, early (30 minutes) and late (within first week)
Core biopsy accuracy.
Comparison of cancer positive pathology data between 12 and 20 core-biopsy with their respective radical prostatectomy hole mount pathology specimen (when treatment was indicated).
Measured: Through study completion, at time of surgery.
Pain perception using pain analogue scale.
Compare pain perception of two anesthesia scheme base versus base plus apex using the visual pain analogue scale immediately after the biopsy and 30 minutes later. The investigators will also compared the analgesia of these schemes according to PSA, PSA density, free/total PSA ratio, prostate volume, previous biopsy.
Measured: Immediate and early (30 minutes after biopsy).
Number of participants with prostate cancer detected according to PSA value
The investigators will also compare the detection rate of 12 versus 20 fragments schemes according to the PSA value.
Measured: Through study completion, an average of four years.
Number of participants with prostate cancer detected according to PSA density.
The investigators will also compare the detection rate of 12 versus 20 fragments schemes according to the PSA density.
Measured: Through study completion, an average of four years.
Number of participants with prostate cancer detected according to free/total PSA ratio.
The investigators will also compare the detection rate of 12 versus 20 fragments schemes according to the PSA free/total PSA ratio.
Measured: Through study completion, an average of four years.
Number of participants with prostate cancer detected according to prostate volume.
The investigators will also compare the detection rate of 12 versus 20 fragments schemes according to prostate volume.
Measured: Through study completion, an average of four years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startMay 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Brigadeiro UGA V-SP
- Responsible party
- Principal investigator, Jose Pontes Jr, University of Nove de Julho
- Investigators
- Jose Pontes Jr, MD PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825225
- Sponsor's protocol ID
- Prostate biopsy - 01
- Status last verified
- Jul 2016
- First submitted
- 26 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Secrecy will be maintained in observation of ethics committee opinion.
Publications
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.
PubMed 22700443Giovannucci 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.
PubMed 17450530Crawford ED. Epidemiology of prostate cancer. Urology. 2003 Dec 22;62(6 Suppl 1):3-12. doi: 10.1016/j.urology.2003.10.013.
PubMed 14706503Schroder 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.
PubMed 22417251Ross 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.
PubMed 20439642Thompson 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.
PubMed 12824459Zisman 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.
PubMed 11176394Nash 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.
PubMed 8558671Rodriguez-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.
PubMed 21496851Sfakianos 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.
PubMed 21627750Remzi 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.
PubMed 16145388Zaytoun 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.
PubMed 21692866Ukimura 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.
PubMed 23021971Pepe 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.
PubMed 18158033Sonn 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.
PubMed 23158413
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial To Assess and Compare the Outcomes of 20-core Versus 12-core Prostate Biopsy
- ClinicalTrials.gov ID
- NCT02825225
- Acronym / sponsor ID
- Prostate biopsy - 01
- Conditions
- Prostate Cancer, Local Anesthesia, Prostate-Specific Antigen/Blood, Biopsy/Methods, Image-guided Biopsy/Methods, Prostatic Neoplasms/Diagnosis
- Keywords
- Prostatic Neoplasms, Biopsy, Anesthesia, Detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Hospital Brigadeiro UGA V-SP
- Study start
- May 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prostate cancer is male's leading solid non-cutaneous tumor, and the second cause of cancer death in western countries. The main risk factors are age (5th decade or more), family history and life-style (low physical activity and occidental dietary habit). Due to it's high incidence and mortality, the screening protocols continue to be supported worldwide by the urologic and oncologic societies. The diagnosis of this disease needs histological evidence that is obtained by prostate biopsy which is indicated when prostate specific antigen (PSA) serum levels are elevated or there is suspicion at digital rectal examination. Actual estimations conclude that more than 200.000 new cases are diagnosed per-year in US and much more patients are submitted to biopsies; turning prostate biopsy a routine medical procedure. In therms of current medical evidence there is controversy in some biopsy aspects. The ideal number of fragments to be obtained is not well established. While twelve core is believed to be the minimum to be sampled, the maximum number is not clear. To ease the estimation of the number of necessary core at biopsy the literature recommend the use of nomograms; they adequate the number of removed fragments according to each individual characteristics such as age, volume, previous biopsy and PSA levels. The prostate biopsy is considered a painful procedure by 96% of patients, therefore it is fundamental to soften the soreness employing some form of anesthesia. There is no consensus regarding the ideal protocol but the local anesthesia with the periprostatic blockade is the most employed worldwide. However there is a controversy related to the site of the injection during the periprostatic block in terms of efficacy: base versus apex or both sites.
Considering the epidemiological importance of prostate cancer detection in a continuous aging population, this study protocol was enrolled in a single center high volume urology Brazilian Public Hospital. The patients will be randomized at a 1:1 ratio for the two biopsy schemes and for the two anesthesia templates.The main objective was to compare the detection rate of two different prostate biopsy schemes 20-core versus 12-core prostate biopsy guided by transrectal ultrasound. Secondary objectives were to evaluate pain perception of the two local anesthesia schemes using a validated pain scale. The pain was evaluated using the visual pain scale immediately after the biopsy and one hour after the procedure. The patients were contacted by phone one week after the biopsy to assess the occurrence of any complication. The investigators then compared the major and minor complication rates of 20-core versus 12-core protocol using the Clavien-Dindo scale. In those patients with cancer at the pathologic report that underwent radical prostatectomy, the investigators will also compare the concordance of Gleason score between the biopsy versus surgical specimen according to the biopsy scheme 20-core versus 12-core.
Data was collected since mid 2012 up to june 2016, inclusion and exclusion criteria will be detailed elsewhere. All information was obtained by the main investigator and all procedures were supervised by the main investigator as well.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 core-biopsy fragments | Experimental | Other: 20 core-biopsy fragments, Procedure: Base and apex local anesthesiaPatients 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. |
| Base and apex local anesthesia | Experimental | Other: 20 core-biopsy fragments, Procedure: Base and apex local anesthesiaPatients 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 core-biopsy fragmentsUsing 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. | Other | 20 core-biopsy fragments, Base and apex local anesthesia |
| Base and apex local anesthesiaUsing 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. | Procedure or surgery | 20 core-biopsy fragments, Base and apex local anesthesia |
Primary outcome
Number of participants with prostate cancer detected.
Time frame: Through study completion, an average of four years.
Statistical evaluation comparing detection of prostate cancer in 12-core versus 20 cores.
7 secondary outcomes
Number of participants with complications
Time frame: Immediate, early (30 minutes) and late (within first week)
Core biopsy accuracy.
Time frame: Through study completion, at time of surgery.
Pain perception using pain analogue scale.
Time frame: Immediate and early (30 minutes after biopsy).
Number of participants with prostate cancer detected according to PSA value
Time frame: Through study completion, an average of four years.
Number of participants with prostate cancer detected according to PSA density.
Time frame: Through study completion, an average of four years.
Number of participants with prostate cancer detected according to free/total PSA ratio.
Time frame: Through study completion, an average of four years.
Number of participants with prostate cancer detected according to prostate volume.
Time frame: Through study completion, an average of four years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Results publication: PubMed 22700443Siegel 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.
- Results publication: PubMed 17450530Giovannucci 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.
- Results publication: PubMed 14706503Crawford ED. Epidemiology of prostate cancer. Urology. 2003 Dec 22;62(6 Suppl 1):3-12. doi: 10.1016/j.urology.2003.10.013.
- Results publication: PubMed 22417251Schroder 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.
- Results publication: PubMed 20439642Ross 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.
- Results publication: PubMed 12824459Thompson 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.
- Results publication: PubMed 11176394Zisman 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.
- Results publication: PubMed 8558671Nash 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.
- Results publication: PubMed 21496851Rodriguez-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.
- Results publication: PubMed 21627750Sfakianos 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.
- Results publication: PubMed 16145388Remzi 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.
- Results publication: PubMed 21692866Zaytoun 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.
- European society of Urology guidelines on prostate cancerLink provided by the sponsor.
- Individual participant dataSharing planned: No. Secrecy will be maintained in observation of ethics committee opinion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Pontes Jr, MD PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 core-biopsy fragments and Base and apex local anesthesia in people with Prostate Cancer and Local Anesthesia, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with prostate cancer detected. (time frame: Through study completion, an average of four years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825225, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.