1741 CAREFUL SELECTION AND CLOSE MONITORING OF LOW-RISK PROSTATE CANCER PATIENTS ON AN ACTIVE...

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1741 CAREFUL SELECTION AND CLOSE MONITORING OF LOW-RISK PROSTATE CANCER PATIENTS ON AN ACTIVE SURVEILLANCE PROTOCOL MINIMIZES THE NEED FOR TREATMENT Mark Soloway, Cynthia Soloway*, Kristell Acosta, Ahmed Eldefrawy, Bruce Kava, Murugesan Manoharan, Miami, FL INTRODUCTION AND OBJECTIVES: Due to an increase over the last 20 years in PSA screening and the number of biopsy cores obtained, there has been a dramatic rise (15% to 62%) in the incidence of low-risk prostate cancer (LRPC). Some suggest 50% of cases detected through PSA screening are over-treated. Consequently, ac- tive surveillance (AS) may be the optimal strategy for low-risk (LR) patients as its benefit may outweigh the risks of major Qol implications of treatment. At our institution, 252 patients have been enrolled in an AS protocol as an alternative to treatment for LRPC. METHODS: 213/252 PC patients met our AS criteria for anal- ysis: 1) 12 month follow-up; 2) PSA 15; 3) Gleason score 6; 4) 80 years; and 5) 2 biopsy cores positive with no more than 20% tumor in each core. The patients were asked to adhere to strict guidelines for follow-up: DRE and PSA 3-4 months for the first two years, every 6 months thereafter. Re-biopsy is performed yearly for the first 5 years. RESULTS: 213 patients with a mean age at diagnosis of 64 (median 64) and a mean follow-up of 43 (range of 12-208) months have been followed. 45% have been followed over 3 years; over 30% over 4. On initial repeat biopsy, 51% had no cancer and 46% had a low volume Gleason sum of 6; on the second re-biopsy, 48% had no cancer. 27/213 (12%), with a mean age of 66 (range of 50-78) years, were treated after a mean follow-up of 32 (range of 15-88) months. 11 elected total prostatectomy; 10, radiation; and 6, hormone treatment. No patient has died from PC. None of those patients who elected total prostatectomy have had a biochemical recurrence. Four reasons trig- gered treatment: an increase in Gleason score on re-biopsy, an in- crease in tumor volume on re-biopsy, a change in the clinical stage, and the decision to be treated without cause. PSA doubling time was not a trigger for treatment. Our cohort had an 85% chance of remaining treatment-free (progression-free) on AS for 5 years by Kaplan-Meier analysis; 75% chance for eight years. The Gleason score on the first re-biopsy and months of follow-up predicted treatment 50% of the time. CONCLUSIONS: 88% of patients have remained on active surveillance for an average of 43 months. Over the last three years, our AS cohort has more than doubled and yet our treatment rate of 12% has been a constant with no known recurrences or deaths due to PC. We believe this speaks to careful selection, close monitoring and the efficacy of AS. Source of Funding: None 1742 OUTCOME OF PATIENTS POTENTIALLY SUITABLE FOR ACTIVE SURVEILLANCE UNDERGOING RADICAL PROSTATECTOMY AS FIRST TREATMENT CHOICE. RESULTS OF INTERMEDIATE-TERM FOLLOW-UP. Nazareno Suardi*, Umberto Capitanio, Alberto Briganti, Andrea Gallina, Firas Abdollah, Nicola Fossati, Massimo Freschi, Milan, Italy; Pierre Karakiewicz, Montreal, Canada; Dario Di Trapani, Patrizio Rigatti, Francesco Montorsi, Milan, Italy INTRODUCTION AND OBJECTIVES: Active surveillance cur- rently represents an emerging option for selected patients with low risk prostate. However, long term biochemical recurrence (BCR) data of patients receiving prostate cancer treatment at the time of active surveillance failure are currently unknown. These figures will need to be compared to the outcome of patients potentially suitable for active surveillance but undergoing radical prostatectomy (RP) as the first treatment choice. We thus addressed the biochemical recurrence rates in patients potentially suitable for active surveillance who were treated with RP. METHODS: The study relied on a population of 1197 patients treated with RP and pelvic lymph node dissection (PLND) at a single European tertiary referral center between 2000 and 2008. All patients had complete biopsy and pathological parameters available. For this study purposes, patients potentially suitable for active surveillance according to the criteria proposed by Van den Bergh et al. (cT1-cT2, biopsy Gleason ¡U ¨ 33, PSA ¡U ¨ 10, PSA density 0.2 and positive cores ¡U ¨ 2) were selected, thus resulting in 199 (16.6%) patients in- cluded in the analyses. Kaplan-Meier analyses addressed time to BCR-free survival in this patient population (n199). RESULTS: Mean and median age was 64.6 and 65.5 years, respectively. Mean and median PSA was 5.8 and 5.9 ng/ml, respec- tively. Mean and median number of biopsy cores taken was 17.2 and 18, respectively. At RP, 94.0% of patients had organ confined disease, 4.5% had extracapsular extension, 1.5% had seminal vesicle invasion and 1.0% had lymph node involvement. A significant Gleason score upgrading between biopsy and RP (defined as shift from r biopsy Gleason sum 2-6 to 7 or higher) was recorded in 51 (25.6%) of patients. Mean and median follow-up was 32.5 and 26.5 months, respectively. In the population of patients suitable for active surveillance, only 1 patient developed BCR, thus resulting in a 5-year recurrence free survival of 97%. CONCLUSIONS: Roughly 15% of patients treated with RP may be selected for the active surveillance protocols according to the criteria proposed by Van den Bergh et al. Although long term follow-up data are needed to confirm these findings, our results show that patients poten- tially suitable for active surveillance but treated with RP experience an excellent prognosis. Therefore, the outcome of patients failing active surveillance will need to be compared to the excellent outcome of low risk prostate cancer patients undergoing RP as the first treatment choice. Source of Funding: None 1743 RELATIONSHIP BETWEEN INITIAL PSA DENSITY WITH FUTURE PSA KINETICS AND REPEAT BIOPSIES IN MEN WITH PROSTATE CANCER ON ACTIVE SURVEILLANCE. Ahmed Kotb*, Simon Tanguay, Murilo Luz, Wassim Kassouf, Armen Aprikian, Montreal, Canada INTRODUCTION AND OBJECTIVES: Prostate cancer is a common health problem affecting older men; active surveillance with deferred treatment is an established management option for localized prostate cancer. PSA velocity (PSAV) is a measure of PSA kinetics with an established correlation with disease progression and disease specific mortality, in men receiving treatment for prostate cancer. PSA density (PSAd) has been used as a measure of disease volume as it takes into account, total prostate volume. The objective of our study is to examine the correlation between PSA density (PSAd) at time of diagnosis and serum testosterone, with PSAV, PSA doubling time (PSADT) and tumour progression, on repeat biopsy, in men with prostate cancer on active surveillance. METHODS: Data from 102 patients with clinically localized prostate cancer on active surveillance, in the period between 1992 and 2007, who had the necessary parameters available, were collected. PSAd was calculated and correlated with serum testosterone, PSAV, PSADT, Gleason score at diagnosis, and local progression on repeated biopsies. RESULTS: PSAV was 0.64 and 1.31 ng/ml/year (P 0.02), PSADT of 192 and 113 months (P 0.4) and serum free testosterone 34.2 and 19.5 pg/ml (P 0.0005) for PSAd below and above 0.15 respectively. The rate of detecting high Gleason score (7) at diag- nosis was 6% and 23% for PSAD below and above 0.15 respectively. 101 patients underwent at least a second biopsy and the incidence of upgrading was 10% and 31% for PSAD below and above 0.15 respec- tively (P 0.001). Vol. 183, No. 4, Supplement, Tuesday, June 1, 2010 THE JOURNAL OF UROLOGY e673

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1741CAREFUL SELECTION AND CLOSE MONITORING OF LOW-RISKPROSTATE CANCER PATIENTS ON AN ACTIVE SURVEILLANCEPROTOCOL MINIMIZES THE NEED FOR TREATMENT

Mark Soloway, Cynthia Soloway*, Kristell Acosta, Ahmed Eldefrawy,Bruce Kava, Murugesan Manoharan, Miami, FL

INTRODUCTION AND OBJECTIVES: Due to an increase overthe last 20 years in PSA screening and the number of biopsy coresobtained, there has been a dramatic rise (15% to 62%) in the incidenceof low-risk prostate cancer (LRPC). Some suggest 50% of casesdetected through PSA screening are over-treated. Consequently, ac-tive surveillance (AS) may be the optimal strategy for low-risk (LR)patients as its benefit may outweigh the risks of major Qol implicationsof treatment. At our institution, 252 patients have been enrolled in anAS protocol as an alternative to treatment for LRPC.

METHODS: 213/252 PC patients met our AS criteria for anal-ysis: 1) � 12 month follow-up; 2) PSA � 15; 3) Gleason score � 6;4) � 80 years; and 5) � 2 biopsy cores positive with no more than 20%tumor in each core. The patients were asked to adhere to strictguidelines for follow-up: DRE and PSA 3-4 months for the first twoyears, every 6 months thereafter. Re-biopsy is performed yearly for thefirst 5 years.

RESULTS: 213 patients with a mean age at diagnosis of 64(median � 64) and a mean follow-up of 43 (range of 12-208) monthshave been followed. 45% have been followed over 3 years; over 30%over 4. On initial repeat biopsy, 51% had no cancer and 46% had a lowvolume Gleason sum of � 6; on the second re-biopsy, 48% had nocancer. 27/213 (12%), with a mean age of 66 (range of 50-78) years,were treated after a mean follow-up of 32 (range of 15-88) months. 11elected total prostatectomy; 10, radiation; and 6, hormone treatment.No patient has died from PC. None of those patients who elected totalprostatectomy have had a biochemical recurrence. Four reasons trig-gered treatment: an increase in Gleason score on re-biopsy, an in-crease in tumor volume on re-biopsy, a change in the clinical stage, andthe decision to be treated without cause. PSA doubling time was not atrigger for treatment. Our cohort had an 85% chance of remainingtreatment-free (progression-free) on AS for 5 years by Kaplan-Meieranalysis; 75% chance for eight years. The Gleason score on the firstre-biopsy and months of follow-up predicted treatment 50% of the time.

CONCLUSIONS: 88% of patients have remained on activesurveillance for an average of 43 months. Over the last three years, ourAS cohort has more than doubled and yet our treatment rate of � 12%has been a constant with no known recurrences or deaths due to PC.We believe this speaks to careful selection, close monitoring and theefficacy of AS.

Source of Funding: None

1742OUTCOME OF PATIENTS POTENTIALLY SUITABLE FORACTIVE SURVEILLANCE UNDERGOING RADICALPROSTATECTOMY AS FIRST TREATMENT CHOICE. RESULTSOF INTERMEDIATE-TERM FOLLOW-UP.

Nazareno Suardi*, Umberto Capitanio, Alberto Briganti, AndreaGallina, Firas Abdollah, Nicola Fossati, Massimo Freschi, Milan, Italy;Pierre Karakiewicz, Montreal, Canada; Dario Di Trapani, PatrizioRigatti, Francesco Montorsi, Milan, Italy

INTRODUCTION AND OBJECTIVES: Active surveillance cur-rently represents an emerging option for selected patients with low riskprostate. However, long term biochemical recurrence (BCR) data ofpatients receiving prostate cancer treatment at the time of activesurveillance failure are currently unknown. These figures will need to becompared to the outcome of patients potentially suitable for activesurveillance but undergoing radical prostatectomy (RP) as the firsttreatment choice. We thus addressed the biochemical recurrence ratesin patients potentially suitable for active surveillance who were treatedwith RP.

METHODS: The study relied on a population of 1197 patientstreated with RP and pelvic lymph node dissection (PLND) at a singleEuropean tertiary referral center between 2000 and 2008. All patientshad complete biopsy and pathological parameters available. For thisstudy purposes, patients potentially suitable for active surveillanceaccording to the criteria proposed by Van den Bergh et al. (cT1-cT2,biopsy Gleason ¡U3�3, PSA ¡U10, PSA density �0.2 and positivecores ¡U2) were selected, thus resulting in 199 (16.6%) patients in-cluded in the analyses. Kaplan-Meier analyses addressed time toBCR-free survival in this patient population (n�199).

RESULTS: Mean and median age was 64.6 and 65.5 years,respectively. Mean and median PSA was 5.8 and 5.9 ng/ml, respec-tively. Mean and median number of biopsy cores taken was 17.2 and18, respectively. At RP, 94.0% of patients had organ confined disease,4.5% had extracapsular extension, 1.5% had seminal vesicle invasionand 1.0% had lymph node involvement. A significant Gleason scoreupgrading between biopsy and RP (defined as shift from r biopsyGleason sum 2-6 to 7 or higher) was recorded in 51 (25.6%) of patients.Mean and median follow-up was 32.5 and 26.5 months, respectively. Inthe population of patients suitable for active surveillance, only 1 patientdeveloped BCR, thus resulting in a 5-year recurrence free survivalof 97%.

CONCLUSIONS: Roughly 15% of patients treated with RP maybe selected for the active surveillance protocols according to the criteriaproposed by Van den Bergh et al. Although long term follow-up data areneeded to confirm these findings, our results show that patients poten-tially suitable for active surveillance but treated with RP experience anexcellent prognosis. Therefore, the outcome of patients failing activesurveillance will need to be compared to the excellent outcome of lowrisk prostate cancer patients undergoing RP as the first treatmentchoice.

Source of Funding: None

1743RELATIONSHIP BETWEEN INITIAL PSA DENSITY WITH FUTUREPSA KINETICS AND REPEAT BIOPSIES IN MEN WITHPROSTATE CANCER ON ACTIVE SURVEILLANCE.

Ahmed Kotb*, Simon Tanguay, Murilo Luz, Wassim Kassouf, ArmenAprikian, Montreal, Canada

INTRODUCTION AND OBJECTIVES: Prostate cancer is acommon health problem affecting older men; active surveillance withdeferred treatment is an established management option for localizedprostate cancer.

PSA velocity (PSAV) is a measure of PSA kinetics with anestablished correlation with disease progression and disease specificmortality, in men receiving treatment for prostate cancer. PSA density(PSAd) has been used as a measure of disease volume as it takes intoaccount, total prostate volume. The objective of our study is to examinethe correlation between PSA density (PSAd) at time of diagnosis andserum testosterone, with PSAV, PSA doubling time (PSADT) andtumour progression, on repeat biopsy, in men with prostate cancer onactive surveillance.

METHODS: Data from 102 patients with clinically localizedprostate cancer on active surveillance, in the period between 1992 and2007, who had the necessary parameters available, were collected.PSAd was calculated and correlated with serum testosterone, PSAV,PSADT, Gleason score at diagnosis, and local progression on repeatedbiopsies.

RESULTS: PSAV was 0.64 and 1.31 ng/ml/year (P� 0.02),PSADT of 192 and 113 months (P� 0.4) and serum free testosterone34.2 and 19.5 pg/ml (P� 0.0005) for PSAd below and above 0.15respectively. The rate of detecting high Gleason score (��7) at diag-nosis was 6% and 23% for PSAD below and above 0.15 respectively.101 patients underwent at least a second biopsy and the incidence ofupgrading was 10% and 31% for PSAD below and above 0.15 respec-tively (P� 0.001).

Vol. 183, No. 4, Supplement, Tuesday, June 1, 2010 THE JOURNAL OF UROLOGY� e673