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1442 IS THERE A BEST PRACTICE FOR PREVENTING PROSTATE BIOPSY SEPSIS?
Vol. 187, No. 4S, Supplement, Tuesday, May 22, 2012
METHODS: We retrospectively reviewed the medical records of 3702 transrectal ultrasound guided needle biopsies of the prostate in 3411 patients performed at the last 15 years. Age, psa value, prostate volume, psa density and pathology results of the patients were compared. Furthermore, the second and thy´rd biopsy results and major complications were evaluated. RESULTS: The mean age of the patients was 63.98⫾7.53 (37-86) years, the mean psa value was 13.93 ng/ml, the mean prostate volume was 43.70⫾23.66 cc and the mean psa density was 0.40⫾0.85. When the pathology results of the patients were investigated; at the first biopsy, cancer detection rate was %22.3, Hy´gh Grade PIN detection rate was % 3.2 and ASAP (Atipic small asiner proliferation) detection rate was %8.9. According to the PSA value, patients were divided into 3 groups. In the fy´rst group, PSA value was less than 4 ng/ml and canser detection rate was %12.8. In the second group, PSA value was between 4 and 10 ng/ml and canser detection rate was %16.2. In the thy´rd group, PSA value was hy´gher than 10 ng/ml and canser detection rate was %32.5 (table 2). Also, second biopsy was performed to 271 patients and the thy´rd biopsy was performed to 20 patients. At the second biopsy, prostate canser was found in 50 paty´ents (%18.5) and at the third biopsy prostate canser was found in 4 patients (%20). The major complications of the prostate biopsies were analyzed. Uriner tract infection requiring hospitalization and parenteral antibiotherapy was found in 33 patients. 7 patients were treated for urosepsis. 1 patient died because of urosepsis. Pelvic hematoma due to prostate biopsy was found in 1 patient. CONCLUSIONS: According to the transrectal ultrasound guided prostate needle biopsy results of the 3411 patients, canser detection rate was %22.3 at the first biopsy, %18.5 at the second biopsy and %20 at the thy´rd biopsy. Also, canser was detected approximately one-thy´rd of the patients (%32.5), whose PSA value was higher than 10 ng/ml. Undetected canser patients should be closely followed by the first biopsy and second biopsy in these patients should be noted that the planning may be required. We should not forget that prostate biopsy is not an y´nnocent process because of the complications like pelvic hematoma, urosepsis or even death. Source of Funding: None
1441 THE ROLE OF MULTIPARAMETRIC MRI IN MEN WITH NEGATIVE BIOPSY AND ELEVATED PSA - CAN IT RULE OUT CLINICALLY SIGNIFICANT DISEASE? Mohamed Abd Alazeez*, Hashim U Ahmed, Caroline Moore, Alex Freeman, Clare Allen, Alex Kirkham, Mark Emberton, London, United Kingdom INTRODUCTION AND OBJECTIVES: Men with a prior negative prostate biopsy who have a persistently elevated PSA often undergo a repeat biopsy. Multi-parametric MRI (mp-MRI) may be a more efficient and effective strategy by identifying those men who could avoid a repeat biopsy. We assessed the role of mp-MRI in this setting using an accurate reference standard that can be applied to all men. METHODS: 39 men with at least one prior negative biopsy (range 1-3) and a persistently elevated or rising PSA underwent mpMRI (index test) using T2-W, DWI and DCE imaging (pelvic phased array), followed by 5mm transperineal template prostate mapping (TPM) biopsy (the reference test). Mp-MRI was scored on an ordinal scale of 1-5 (1⫽highly likely no cancer, 5⫽highly likely cancer). A score of 4 or 5 was considered positive and validated against 2 target conditions on TPM to represent clinically significant prostate cancer as well as ‘all cancer’: 1- UCL definition 1: Gleason ⱖ 4⫹3 and/or maximum cancer core length (MCCL) ⱖ 6 mm. 2- UCL definition 2: Gleason ⱖ 3⫹4 and/or MCCL ⱖ 4 mm. Analysis was performed at half prostate level equating to 78 sectors.
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RESULTS: Median PSA was 9ng/ml (mean, 10.4⫾SD5.2), median prostate volume was 52ml (mean, 52⫾SD24.4) and median number of cores was 38 (mean, 44.6⫾SD24). UCL Definition 1 disease was found in 17/78 (22%) prostate halves. UCL Definition 2 disease was found in 27/78 (35%) prostate halves. Cancer of any grade or burden was found in 38/78 (49%) prostate halves. With respect to clinically significant disease, mp-MRI had sensitivity of 70-82%, specificity 77-82%, positive predictive value 50-68% and negative predictive value 84-94%. For all cancer, these values were 58%, 85%, 79% and 68% respectively. CONCLUSIONS: In men with at least one previous negative biopsy, there was a high prevalence of clinically significant cancer and all cancer. A negative mp-MRI rules out clinically significant prostate cancer with negative predictive value of 84-94%. It therefore appears to have diagnostic utility in this setting and could serve as a triage test in order to identify those men who could avoid a repeat biopsy. Source of Funding: Mohamed Abd Alazeez receives funding from the Egyptian government. Hashim Uddin Ahmed and Mark Emberton receive funding from the Medical Research Council, Pelican Cancer Foundation, Prostate UK, St Peter’s Trust, Prostate Cancer Research Foundation and Prostate Cancer Research Centre. Mark Emberton receives research support from the UK National Institute of Health Research UCLH/UCL Comprehensive Biomedical Research Centre, London, UK.
1442 IS THERE A BEST PRACTICE FOR PREVENTING PROSTATE BIOPSY SEPSIS? Gaspar Msangi*, Paul Chittick, Kenneth Peters, Matthew Sims, Jay Hollander, Royal Oak, MI INTRODUCTION AND OBJECTIVES: In an effort to design a research study for prostate biopsy prophylaxis, we needed a protocol that would be accepted by most urologists. Our goal was to assess the practice pattern for prostate biopsy prophylaxis in order to tailor a study that urologists would agree to participate in. METHODS: A questionnaire was designed to assess how urologists perform prostate biopsies. An anonymous online survey was sent to 3363 urologists using Survey Monkey. Descriptive statistics were performed. RESULTS: 235 urologists completed the survey, corresponding to a 7% response rate. 43% of the urologists do 10-15 prostate biopsies a month, with the majority (71%) taking 10-12cores during each biopsy. Only 73% routinely obtain a urinalysis before biopsy. Rectal enema is the preferred prep, used by over 86% of urologist. Most (76%) prefer it done the morning of procedure. Fluoroquinolones are used by 88% of respondents. Most (63%) start antibiotics the night before procedure while others begin 2hours (22%) or 30minutes (16%) before. Post biopsy, 5% give a single dose fluoroquinolone, 27% continue for 24hours, 35% for 48hours, and 33% for 72hours. While there are urologists who will not give post procedure antibiotics, there are those who will continue antibiotics for even up to a week. Aminoglycosides are the most popular IV/IM antibiotics, generally given as a single agent or in combination with oral agents. 67% of urologists report having had patients hospitalized for post-biopsy complications. While the majority (75%) only have 1-2 patients hospitalized every year, a minority (1%) see as many as 8-10 patients hospitalized yearly. 41% of urologists report an increase in frequency of febrile complications from prostate biopsy. Deaths from post biopsy sepsis were reported by 1% of urologists. CONCLUSIONS: Our survey shows that most urologists do not follow AUA guidelines. The AUA recommends giving antibiotics 60minutes before starting procedure and continuing for no more than 24hrs. Most urologists start antibiotics the night before procedure and continue them for a few days. Hospitalization for post biopsy sepsis is not
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uncommon and deaths from prostate biopsy were reported. Febrile complications after prostate biopsy seem to be increasing. There is a need to perform a well-controlled trial to determine the best prophylaxis for prostate biopsy. We believe this data will help us design one for our institution. Source of Funding: Oakland University William Beaumont Hospital Research Foundation
1443 PSA STRATIFIES RISK OF PROSTATE CANCER AFTER HIGH GRADE PROSTATIC INTRAEPITHELIAL NEOPLASIA Ravi Kacker, Sherif Elsobky*, Kevin Loughlin, Boston, MA INTRODUCTION AND OBJECTIVES: Patients with high-grade prostatic intraepithelial neoplasia (HGPIN) may have an increased risk of developing prostate cancer (CaP). We examined the risk of HGPIN based on PSA stratification. METHODS: An institutional review board approved database identified 476 men who underwent prostate needle biopsy at our institution and had PSA follow-up data available in the medical record. High grade CaP was defined as Gleason 4⫹3 or greater. The risk of CaP after HGPIN was examined based on PSA follow-up. RESULTS: HGPIN was present in 91 men (19.1%) and conferred an increased risk of CaP (OR 5.965; p⬍0.0001) and high grade CaP (OR 3.598; p⬍0.0001) over a median follow-up of 24 months. On logistic regression models, PSA is associated with an increased risk of CaP (OR 1.21; p⫽0.0113) for men with HGPIN. The increased risk of CaP did not reach significance until PSA exceeded 6 ng/ml (OR 3.917; p⫽0.0043). PSA is not significantly associated with high grade CaP after HGPIN (p⫽0.274). However, all 9 patients (9.78%) who developed high grade CaP had PSA ⬎ 4ng/ml (mean 7.15 ⫾ 4.04 ng/ml). CONCLUSIONS: There is an increased risk of CaP for patients with HGPIN and elevated PSA, particularly for those with PSA ⬎6ng/ ml. Further research is needed to determine optimal PSA screening guidelines after identification of HGPIN. Source of Funding: None
1444 WHAT BURDEN OF PROSTATE CANCER IS MISSED BY A NEGATIVE MULTI-PARAMETRIC MRI? AN ANALYSIS BASED ON TEMPLATE PROSTATE MAPPING AS THE REFERENCE STANDARD Hashim Ahmed*, Nimalan Arumainayagam, Alex Freeman, S Aslam Sohaib, Alex Kirkham, Clare Allen, Mark Emberton, London, United Kingdom INTRODUCTION AND OBJECTIVES: Much discussion has recently centred on the role of multi-parametric (mp)MRI in ruling-out clinically significant prostate cancer. Studies to date have set the target condition at various thresholds of ‘clinical significance’: from ‘all cancer’ or those lesions of volume ⬎/⫽0.2cc or ⬎/⫽0.5cc. The performance characteristics of mpMRI has a positive correlation with cancer volume, but there is uncertainty as to the disease burden that mpMRI misses when it is called ‘negative’or ‘normal2’. METHODS: From 2006 to 2008, 64 men seeking reclassification of disease status (previous positive TRUS⫽51, no previous TRUS⫽3, previous negative TRUS⫽10) underwent mpMRI (1.5T, pelvic phased array, T2W, Diffusion, Dynamic Contrast) followed by Template Prostate Mapping (TPM). 3 radiologists independently reported scans blind to pathology using an ordinal scale of 1-5 (1⫽highly likely benign, 5⫽highly likely malignant) and 4 sectors per prostate (quadrants). The target condition to indicate a positive outcome on TPM was derived by varying the Maximum Cancer Core Length (MCCL) and Total Cancer Core Length (TCCL) thresholds from 1mm to 10mm. TCCL indicated the total amount of cancer from all positive cores in a sector of analysis. Sensitivity, specificity, negative and positive predic-
Vol. 187, No. 4S, Supplement, Tuesday, May 22, 2012
tive values were calculated at each MCCL and TCCL threshold. The MCCL and TCCL values that gave rise to a negative predictive value (NPV) of ⬎/⫽95% for mpMRI were derived. RESULTS: Mean age was 62 years (range 40-76) and mean PSA 8.2ug/L (range 2.1– 43). 54 men had cancer on TPM of which 18 had Gleason ⬍/⫽3⫹3. 127/256 (50%) sectors had cancer of which 83/127 (67%) had Gleason ⬍/⫽3⫹3. The sectors with no Gleason pattern 4 were used to derive endpoints for the purpose of this study, as this excluded the strong confounding variable of Gleason grade. Using a radiological score of ⬎/⫽3, the MCCL and TCCL values that gave rise to a NPV of 95% for mpMRI were 4-6mm and 4-8mm, respectively. Using a radiological score of ⬎/⫽4, the MCCL and TCCL values that gave rise to a NPV of 95% for mpMRI were 5-7mm and 6-10mm, respectively. If the MCCL values we have derived are used as diameters for a perfect sphere, then lesion volumes would be 0.03ml to 0.18ml. The NPV cancer with Gleason ⬎/⫽3⫹4 was 90-95%, regardless of MCCL/TCCL. CONCLUSIONS: If a prostate is deemed ‘negative’ on mpMRI, the maximum amount of prostate cancer that can still be present is 0.18ml and Gleason 3⫹3. mpMRI seems to have the ideal attributes of a triage diagnostic test to identify those men that could be advised to avoid a prostate biopsy. Source of Funding: Medical Research Council (UK), Pelican Cancer Foundation, Prostate Action, St Peters Trust
1445 IMPACT OF SERIAL PROSTATE BIOPSIES ON LOWER URINARY TRACT SYMPTOMS IN MEN ON ACTIVE SURVEILLANCE FOR PROSTATE CANCER Allison S. Glass*, Joan F. Hilton, Samuel L. Washington, Jared M. Whitson, Janet E. Cowan, Katsuto Shinohara, Matthew R. Cooperberg, Maxwell V. Meng, Kirsten L. Greene, Peter R. Carroll, San Francisco, CA INTRODUCTION AND OBJECTIVES: Patients with low-risk prostate cancer are increasingly choosing active surveillance (AS) as an initial management strategy. Monitoring includes regular transrectal ultrasound (TRUS) guided biopsies. Such biopsies may induce lower urinary tract symptoms (LUTS) by a variety of mechanisms. We attempt to describe the long-term cumulative effects of serial TRUS-guided biopsies on LUTS in men with prostate cancer on AS. METHODS: The study group included men on AS who received TRUS guided biopsies at 12-18 month intervals and completed one or more quality of life questionnaires after biopsy. Urinary symptoms were assessed using the total International Prostate Symptom Score (IPSS) 7-question survey. Associations between age, partner status, biopsy number, diagnosis year, prostate volume, and total IPSS score were tested using Pearson correlation and chi-square. Relationships of demographic and clinical variables with IPSS scores across biopsies were evaluated using repeated measures mixed modeling. RESULTS: Since 2003, 421 men have undergone TRUSguided prostate biopsy and 1413 provided post-biopsy IPSS surveys. Median age was 61 years (interquartile range, IQR 57-66) and 79% of men had spouses or life partners. At diagnosis, 69% had cT1 disease and 93% had biopsy Gleason score 2-6. Median prostate volume was 36 mL (IQR 26-49 mL). Median IPSS score was 7 (IQR 4-10) at 1st biopsy and 10 (IQR 5-13) at 5th biopsy. Only patients who underwent ⱖ5 biopsies had higher IPSS scores (p ⫽ 0.04). Other variables associated with higher IPSS score included age (p ⬍0.01), relationship status (p ⫽ 0.03) and prostate volume (p⬍0.01). IPSS score was not associated with year of cancer diagnosis. CONCLUSIONS: Total IPSS score was associated with having 5 or more biopsies, age, prostate volume and partner status. Though patients may experience a small worsening in urinary symptoms after repeated biopsy, the expected clinical impact appears limited. Source of Funding: None
METHODS: We retrospectively reviewed the medical records of 3702 transrectal ultrasound guided needle biopsies of the prostate in 3411 patients performed at the last 15 years. Age, psa value, prostate volume, psa density and pathology results of the patients were compared. Furthermore, the second and thy´rd biopsy results and major complications were evaluated. RESULTS: The mean age of the patients was 63.98⫾7.53 (37-86) years, the mean psa value was 13.93 ng/ml, the mean prostate volume was 43.70⫾23.66 cc and the mean psa density was 0.40⫾0.85. When the pathology results of the patients were investigated; at the first biopsy, cancer detection rate was %22.3, Hy´gh Grade PIN detection rate was % 3.2 and ASAP (Atipic small asiner proliferation) detection rate was %8.9. According to the PSA value, patients were divided into 3 groups. In the fy´rst group, PSA value was less than 4 ng/ml and canser detection rate was %12.8. In the second group, PSA value was between 4 and 10 ng/ml and canser detection rate was %16.2. In the thy´rd group, PSA value was hy´gher than 10 ng/ml and canser detection rate was %32.5 (table 2). Also, second biopsy was performed to 271 patients and the thy´rd biopsy was performed to 20 patients. At the second biopsy, prostate canser was found in 50 paty´ents (%18.5) and at the third biopsy prostate canser was found in 4 patients (%20). The major complications of the prostate biopsies were analyzed. Uriner tract infection requiring hospitalization and parenteral antibiotherapy was found in 33 patients. 7 patients were treated for urosepsis. 1 patient died because of urosepsis. Pelvic hematoma due to prostate biopsy was found in 1 patient. CONCLUSIONS: According to the transrectal ultrasound guided prostate needle biopsy results of the 3411 patients, canser detection rate was %22.3 at the first biopsy, %18.5 at the second biopsy and %20 at the thy´rd biopsy. Also, canser was detected approximately one-thy´rd of the patients (%32.5), whose PSA value was higher than 10 ng/ml. Undetected canser patients should be closely followed by the first biopsy and second biopsy in these patients should be noted that the planning may be required. We should not forget that prostate biopsy is not an y´nnocent process because of the complications like pelvic hematoma, urosepsis or even death. Source of Funding: None
1441 THE ROLE OF MULTIPARAMETRIC MRI IN MEN WITH NEGATIVE BIOPSY AND ELEVATED PSA - CAN IT RULE OUT CLINICALLY SIGNIFICANT DISEASE? Mohamed Abd Alazeez*, Hashim U Ahmed, Caroline Moore, Alex Freeman, Clare Allen, Alex Kirkham, Mark Emberton, London, United Kingdom INTRODUCTION AND OBJECTIVES: Men with a prior negative prostate biopsy who have a persistently elevated PSA often undergo a repeat biopsy. Multi-parametric MRI (mp-MRI) may be a more efficient and effective strategy by identifying those men who could avoid a repeat biopsy. We assessed the role of mp-MRI in this setting using an accurate reference standard that can be applied to all men. METHODS: 39 men with at least one prior negative biopsy (range 1-3) and a persistently elevated or rising PSA underwent mpMRI (index test) using T2-W, DWI and DCE imaging (pelvic phased array), followed by 5mm transperineal template prostate mapping (TPM) biopsy (the reference test). Mp-MRI was scored on an ordinal scale of 1-5 (1⫽highly likely no cancer, 5⫽highly likely cancer). A score of 4 or 5 was considered positive and validated against 2 target conditions on TPM to represent clinically significant prostate cancer as well as ‘all cancer’: 1- UCL definition 1: Gleason ⱖ 4⫹3 and/or maximum cancer core length (MCCL) ⱖ 6 mm. 2- UCL definition 2: Gleason ⱖ 3⫹4 and/or MCCL ⱖ 4 mm. Analysis was performed at half prostate level equating to 78 sectors.
THE JOURNAL OF UROLOGY姞
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RESULTS: Median PSA was 9ng/ml (mean, 10.4⫾SD5.2), median prostate volume was 52ml (mean, 52⫾SD24.4) and median number of cores was 38 (mean, 44.6⫾SD24). UCL Definition 1 disease was found in 17/78 (22%) prostate halves. UCL Definition 2 disease was found in 27/78 (35%) prostate halves. Cancer of any grade or burden was found in 38/78 (49%) prostate halves. With respect to clinically significant disease, mp-MRI had sensitivity of 70-82%, specificity 77-82%, positive predictive value 50-68% and negative predictive value 84-94%. For all cancer, these values were 58%, 85%, 79% and 68% respectively. CONCLUSIONS: In men with at least one previous negative biopsy, there was a high prevalence of clinically significant cancer and all cancer. A negative mp-MRI rules out clinically significant prostate cancer with negative predictive value of 84-94%. It therefore appears to have diagnostic utility in this setting and could serve as a triage test in order to identify those men who could avoid a repeat biopsy. Source of Funding: Mohamed Abd Alazeez receives funding from the Egyptian government. Hashim Uddin Ahmed and Mark Emberton receive funding from the Medical Research Council, Pelican Cancer Foundation, Prostate UK, St Peter’s Trust, Prostate Cancer Research Foundation and Prostate Cancer Research Centre. Mark Emberton receives research support from the UK National Institute of Health Research UCLH/UCL Comprehensive Biomedical Research Centre, London, UK.
1442 IS THERE A BEST PRACTICE FOR PREVENTING PROSTATE BIOPSY SEPSIS? Gaspar Msangi*, Paul Chittick, Kenneth Peters, Matthew Sims, Jay Hollander, Royal Oak, MI INTRODUCTION AND OBJECTIVES: In an effort to design a research study for prostate biopsy prophylaxis, we needed a protocol that would be accepted by most urologists. Our goal was to assess the practice pattern for prostate biopsy prophylaxis in order to tailor a study that urologists would agree to participate in. METHODS: A questionnaire was designed to assess how urologists perform prostate biopsies. An anonymous online survey was sent to 3363 urologists using Survey Monkey. Descriptive statistics were performed. RESULTS: 235 urologists completed the survey, corresponding to a 7% response rate. 43% of the urologists do 10-15 prostate biopsies a month, with the majority (71%) taking 10-12cores during each biopsy. Only 73% routinely obtain a urinalysis before biopsy. Rectal enema is the preferred prep, used by over 86% of urologist. Most (76%) prefer it done the morning of procedure. Fluoroquinolones are used by 88% of respondents. Most (63%) start antibiotics the night before procedure while others begin 2hours (22%) or 30minutes (16%) before. Post biopsy, 5% give a single dose fluoroquinolone, 27% continue for 24hours, 35% for 48hours, and 33% for 72hours. While there are urologists who will not give post procedure antibiotics, there are those who will continue antibiotics for even up to a week. Aminoglycosides are the most popular IV/IM antibiotics, generally given as a single agent or in combination with oral agents. 67% of urologists report having had patients hospitalized for post-biopsy complications. While the majority (75%) only have 1-2 patients hospitalized every year, a minority (1%) see as many as 8-10 patients hospitalized yearly. 41% of urologists report an increase in frequency of febrile complications from prostate biopsy. Deaths from post biopsy sepsis were reported by 1% of urologists. CONCLUSIONS: Our survey shows that most urologists do not follow AUA guidelines. The AUA recommends giving antibiotics 60minutes before starting procedure and continuing for no more than 24hrs. Most urologists start antibiotics the night before procedure and continue them for a few days. Hospitalization for post biopsy sepsis is not
e586
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uncommon and deaths from prostate biopsy were reported. Febrile complications after prostate biopsy seem to be increasing. There is a need to perform a well-controlled trial to determine the best prophylaxis for prostate biopsy. We believe this data will help us design one for our institution. Source of Funding: Oakland University William Beaumont Hospital Research Foundation
1443 PSA STRATIFIES RISK OF PROSTATE CANCER AFTER HIGH GRADE PROSTATIC INTRAEPITHELIAL NEOPLASIA Ravi Kacker, Sherif Elsobky*, Kevin Loughlin, Boston, MA INTRODUCTION AND OBJECTIVES: Patients with high-grade prostatic intraepithelial neoplasia (HGPIN) may have an increased risk of developing prostate cancer (CaP). We examined the risk of HGPIN based on PSA stratification. METHODS: An institutional review board approved database identified 476 men who underwent prostate needle biopsy at our institution and had PSA follow-up data available in the medical record. High grade CaP was defined as Gleason 4⫹3 or greater. The risk of CaP after HGPIN was examined based on PSA follow-up. RESULTS: HGPIN was present in 91 men (19.1%) and conferred an increased risk of CaP (OR 5.965; p⬍0.0001) and high grade CaP (OR 3.598; p⬍0.0001) over a median follow-up of 24 months. On logistic regression models, PSA is associated with an increased risk of CaP (OR 1.21; p⫽0.0113) for men with HGPIN. The increased risk of CaP did not reach significance until PSA exceeded 6 ng/ml (OR 3.917; p⫽0.0043). PSA is not significantly associated with high grade CaP after HGPIN (p⫽0.274). However, all 9 patients (9.78%) who developed high grade CaP had PSA ⬎ 4ng/ml (mean 7.15 ⫾ 4.04 ng/ml). CONCLUSIONS: There is an increased risk of CaP for patients with HGPIN and elevated PSA, particularly for those with PSA ⬎6ng/ ml. Further research is needed to determine optimal PSA screening guidelines after identification of HGPIN. Source of Funding: None
1444 WHAT BURDEN OF PROSTATE CANCER IS MISSED BY A NEGATIVE MULTI-PARAMETRIC MRI? AN ANALYSIS BASED ON TEMPLATE PROSTATE MAPPING AS THE REFERENCE STANDARD Hashim Ahmed*, Nimalan Arumainayagam, Alex Freeman, S Aslam Sohaib, Alex Kirkham, Clare Allen, Mark Emberton, London, United Kingdom INTRODUCTION AND OBJECTIVES: Much discussion has recently centred on the role of multi-parametric (mp)MRI in ruling-out clinically significant prostate cancer. Studies to date have set the target condition at various thresholds of ‘clinical significance’: from ‘all cancer’ or those lesions of volume ⬎/⫽0.2cc or ⬎/⫽0.5cc. The performance characteristics of mpMRI has a positive correlation with cancer volume, but there is uncertainty as to the disease burden that mpMRI misses when it is called ‘negative’or ‘normal2’. METHODS: From 2006 to 2008, 64 men seeking reclassification of disease status (previous positive TRUS⫽51, no previous TRUS⫽3, previous negative TRUS⫽10) underwent mpMRI (1.5T, pelvic phased array, T2W, Diffusion, Dynamic Contrast) followed by Template Prostate Mapping (TPM). 3 radiologists independently reported scans blind to pathology using an ordinal scale of 1-5 (1⫽highly likely benign, 5⫽highly likely malignant) and 4 sectors per prostate (quadrants). The target condition to indicate a positive outcome on TPM was derived by varying the Maximum Cancer Core Length (MCCL) and Total Cancer Core Length (TCCL) thresholds from 1mm to 10mm. TCCL indicated the total amount of cancer from all positive cores in a sector of analysis. Sensitivity, specificity, negative and positive predic-
Vol. 187, No. 4S, Supplement, Tuesday, May 22, 2012
tive values were calculated at each MCCL and TCCL threshold. The MCCL and TCCL values that gave rise to a negative predictive value (NPV) of ⬎/⫽95% for mpMRI were derived. RESULTS: Mean age was 62 years (range 40-76) and mean PSA 8.2ug/L (range 2.1– 43). 54 men had cancer on TPM of which 18 had Gleason ⬍/⫽3⫹3. 127/256 (50%) sectors had cancer of which 83/127 (67%) had Gleason ⬍/⫽3⫹3. The sectors with no Gleason pattern 4 were used to derive endpoints for the purpose of this study, as this excluded the strong confounding variable of Gleason grade. Using a radiological score of ⬎/⫽3, the MCCL and TCCL values that gave rise to a NPV of 95% for mpMRI were 4-6mm and 4-8mm, respectively. Using a radiological score of ⬎/⫽4, the MCCL and TCCL values that gave rise to a NPV of 95% for mpMRI were 5-7mm and 6-10mm, respectively. If the MCCL values we have derived are used as diameters for a perfect sphere, then lesion volumes would be 0.03ml to 0.18ml. The NPV cancer with Gleason ⬎/⫽3⫹4 was 90-95%, regardless of MCCL/TCCL. CONCLUSIONS: If a prostate is deemed ‘negative’ on mpMRI, the maximum amount of prostate cancer that can still be present is 0.18ml and Gleason 3⫹3. mpMRI seems to have the ideal attributes of a triage diagnostic test to identify those men that could be advised to avoid a prostate biopsy. Source of Funding: Medical Research Council (UK), Pelican Cancer Foundation, Prostate Action, St Peters Trust
1445 IMPACT OF SERIAL PROSTATE BIOPSIES ON LOWER URINARY TRACT SYMPTOMS IN MEN ON ACTIVE SURVEILLANCE FOR PROSTATE CANCER Allison S. Glass*, Joan F. Hilton, Samuel L. Washington, Jared M. Whitson, Janet E. Cowan, Katsuto Shinohara, Matthew R. Cooperberg, Maxwell V. Meng, Kirsten L. Greene, Peter R. Carroll, San Francisco, CA INTRODUCTION AND OBJECTIVES: Patients with low-risk prostate cancer are increasingly choosing active surveillance (AS) as an initial management strategy. Monitoring includes regular transrectal ultrasound (TRUS) guided biopsies. Such biopsies may induce lower urinary tract symptoms (LUTS) by a variety of mechanisms. We attempt to describe the long-term cumulative effects of serial TRUS-guided biopsies on LUTS in men with prostate cancer on AS. METHODS: The study group included men on AS who received TRUS guided biopsies at 12-18 month intervals and completed one or more quality of life questionnaires after biopsy. Urinary symptoms were assessed using the total International Prostate Symptom Score (IPSS) 7-question survey. Associations between age, partner status, biopsy number, diagnosis year, prostate volume, and total IPSS score were tested using Pearson correlation and chi-square. Relationships of demographic and clinical variables with IPSS scores across biopsies were evaluated using repeated measures mixed modeling. RESULTS: Since 2003, 421 men have undergone TRUSguided prostate biopsy and 1413 provided post-biopsy IPSS surveys. Median age was 61 years (interquartile range, IQR 57-66) and 79% of men had spouses or life partners. At diagnosis, 69% had cT1 disease and 93% had biopsy Gleason score 2-6. Median prostate volume was 36 mL (IQR 26-49 mL). Median IPSS score was 7 (IQR 4-10) at 1st biopsy and 10 (IQR 5-13) at 5th biopsy. Only patients who underwent ⱖ5 biopsies had higher IPSS scores (p ⫽ 0.04). Other variables associated with higher IPSS score included age (p ⬍0.01), relationship status (p ⫽ 0.03) and prostate volume (p⬍0.01). IPSS score was not associated with year of cancer diagnosis. CONCLUSIONS: Total IPSS score was associated with having 5 or more biopsies, age, prostate volume and partner status. Though patients may experience a small worsening in urinary symptoms after repeated biopsy, the expected clinical impact appears limited. Source of Funding: None