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Objectives: To investigate sociodemographic factors influencing decision of initially active surveillance (AS) prostate cancer (CaP) patients to opt for definitive therapy, and, specifically, choice of radical prostatectomy (RP) versus radiation therapy (XRT)., Methods: The Surveillance, Epidemiology, and End Results (SEER) Prostate with Watchful Waiting database was used to identify AS patients diagnosed with NCCN low-risk CaP between 2010 and 2015. We sought to determine predictors of treatment type using multivariable logistic regression analyses., Results: Out of 32,874 men included, 21,255 (64.7%) underwent delayed treatment, with 3,751 (17.6%) and 17,463 (82.2%) opting for RP and XRT, respectively. Patients who were married (Odds Ratio [OR]: 1.18, P <.001), insured (OR 2.94, P <.001), of higher socioeconomic status (OR 1.67 for highest vs lowest, P <.01), and residing in a Southeastern or Midwestern region (ORs 1.26 and 1.22 vs Northeast, respectively, P <.01) were significantly more likely to undergo definitive intervention. A significant interaction between patient race and marital/socioeconomic statuses on the decision-making process was identified. Decision for XRT (vs RP) was more likely in older (OR 11.6 for 70-79 vs 50-59 years, P <.01), unmarried (OR 1.89, P <.01), African American (OR 1.41, P .018), and higher socioeconomic status (OR 1.54 for highest versus lowest quartile, P <.01) patients., Conclusion: The majority of patients initially treated with AS underwent delayed treatment. After accounting for pathologic characteristics, the interaction of sociodemographic factors including race, socioeconomic status, marital status, insurance status, and region of residence are significantly associated with the likelihood of undergoing definitive therapy., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: To define the role of focal laser ablation (FLA) as clinical treatment of prostate cancer (PCa) using the Delphi consensus method., Methods: A panel of international experts in the field of focal therapy (FT) in PCa conducted a collaborative consensus project using the Delphi method. Experts were invited to online questionnaires focusing on patient selection and treatment of PCa with FLA during four subsequent rounds. After each round, outcomes were displayed, and questionnaires were modified based on the comments provided by panelists. Results were finalized and discussed during face-to-face meetings., Results: Thirty-seven experts agreed to participate, and consensus was achieved on 39/43 topics. Clinically significant PCa (csPCa) was defined as any volume Grade Group 2 [Gleason score (GS) 3+4]. Focal therapy was specified as treatment of all csPCa and can be considered primary treatment as an alternative to radical treatment in carefully selected patients. In patients with intermediate-risk PCa (GS 3+4) as well as patients with MRI-visible and biopsy-confirmed local recurrence, FLA is optimal for targeted ablation of a specific magnetic resonance imaging (MRI)-visible focus. However, FLA should not be applied to candidates for active surveillance and close follow-up is required. Suitability for FLA is based on tumor volume, location to vital structures, GS, MRI-visibility, and biopsy confirmation., Conclusion: Focal laser ablation is a promising technique for treatment of clinically localized PCa and should ideally be performed within approved clinical trials. So far, only few studies have reported on FLA and further validation with longer follow-up is mandatory before widespread clinical implementation is justified.

Unlabelled: Study Type - Therapy (case series). Level of Evidence 4. What's known on the subject? and What does the study add? Low-risk prostate cancer is frequently diagnosed in the context of PSA screening or during a routine check-up. For those patients, to avoid possible overtreatment AS is an increasingly chosen treatment option. However, the concept of AS could possibly misclassify potentially dangerous PCa as a low-risk disease resulting in inferior cancer control outcomes. In the present study, we could demonstrate that the histopathological results of patients treated by RP in course of AS are significantly better if the selection criteria for AS are entirely fulfilled. Our findings underline the importance of a strict and precise admittance procedure for patients with early prostate cancer who are willing to undergo an AS programme., Objective: • To compare the histopathological outcomes of patients treated with radical prostatectomy (RP) after an initial active surveillance (AS) for localized, low-risk prostate cancers (PCa) among men who fulfilled the Epstein criteria at diagnosis with those who did not., Patients and Methods: • In all, 283 patients with localized PCa were initially managed at our institution with AS. • In all, ≈ 50% originated from the European Randomized Study of Screening for Prostate Cancer (ERSPC) participants from Switzerland: 75 (26.5%) patients underwent treatment during follow-up and 61 were treated with RP (21.6%). • These patients were stratified into those who did (n= 39) vs those who did not (n= 22) entirely fulfil AS inclusion criteria according to Epstein et al. at PCa diagnosis., Results: • Patients who did completely fulfil the AS inclusion criteria had significantly lower prostate-specific antigen (PSA)-values (4.9 vs 7.8 ng/mL; P= 0.02), a significantly lower PSA density at diagnosis (0.09 vs 0.2 ng/mL/ccm; P= 0.007) and at RP, a higher proportion of organ-confined cancers (89.7% vs 59.1%, P= 0.02) and fewer positive surgical margins (25.6% vs 40.9%). • However, the rate of favourable histopathological outcome, defined as organ-confined disease with negative surgical margins, was statistically significantly higher in the group fulfilling AS criteria (69.2% vs 40.9%; P= 0.03)., Conclusions: • In our AS series, 26.5% of the patients underwent definitive therapy. • Most patients treated with RP had organ-confined disease in the majority of cases, especially when the Epstein criteria were rigorously fulfilled at PCa diagnosis. • This underlines the importance of a strict and precise per protocol AS for patients with early PCa, otherwise there is a risk of missing more significant disease., (© 2011 BJU INTERNATIONAL.)

Context: Prostate cancer (PCa) recurrence following definitive radiation therapy (RT) remains a vexing challenge for the practicing physician. Salvage radical prostatectomy (SRP) has not been recognized yet as a valuable therapeutic option., Objective: We critically analyzed the currently available evidence on SRP as to patient selection, predictive oncologic factors, surgical technique, cancer control, surgical complications, functional outcomes, and comparison to other salvage therapies., Evidence Acquisition: A systematic review of the literature was performed in June 2011 using the Medline, Embase, and Web of Science databases, limiting the review to English-language articles published between January 1980 and June 2011. All authors reviewed the list of references and added papers relevant to the topic of the review prior to the analysis. The panel selected 40 articles according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria., Evidence Synthesis: Positive surgical margins in SRP varied from 43% to 70% in earlier publications versus 0-36% in recent publications, and pathologic organ-confined disease (OCD) was found in 22-53% versus 44-73% in earlier versus recent publications. Biochemical recurrence-free probability after SRP ranged from 47% to 82% at 5 yr and from 28% to 53% at 10 yr. Cancer-specific survival (CSS) and overall survival varied from 70% to 83% and 54% to 89% at 10 yr. Pre-SRP prostate-specific antigen value and prostate biopsy Gleason score were the strongest prognostic risk factors for progression-free survival, OCD, and CSS. Open, laparoscopic, and robotic techniques were shown to be feasible in the hands of experienced surgeons. The most frequent complications included anastomotic stricture (7-41%) followed by rectal injury (0-28%). Major complications (modified Clavien classification grade 3-5) varied from 0% to 25%. Most complications were less frequent in more recent series, except for anastomotic stricture. The majority of patients had erectile dysfunction prior to SRP (50-91%) and 80-100% after SRP. Urinary continence ranged from 21% to 90% after surgery. Limitations of this review include the absence of prospective studies and lack of comparative analyses between SRP and other therapies., Conclusions: In selected patients with confirmed, localized, radiation-recurrent PCa, SRP may effectively promote durable cancer control with acceptable associated surgical morbidity and variable functional recovery., (Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Purpose: High intensity focused ultrasound for the treatment of primary prostate cancer is increasing in a subset of men seeking definitive treatment with reduced morbidity. We review outcomes in men undergoing salvage radical prostatectomy after failed whole gland high intensity focused ultrasound., Materials and Methods: Prospective data were collected for men presenting with an increasing prostate specific antigen and biopsy proven prostate cancer after high intensity focused ultrasound from 2007 to 2010 who underwent salvage open radical prostatectomy with a 22-month median followup, including prostate specific antigen, prostate volume, pathology results, continence and erectile function., Results: Data for 15 men were available, including median age 64 years (IQR 55-69), Gleason score before high intensity focused ultrasound of 6 (8), Gleason score 7 (7), median cores positive 39% (IQR 17%-63%) and median prostate specific antigen 7 ng/ml (IQR 5-8). Whole gland high intensity focused ultrasound achieved median nadir prostate specific antigen 1.1 ng/ml (IQR 0.5-3.1). Biopsy after high intensity focused ultrasound demonstrated Gleason score 6 (in 3 patients), 7 (9) and 8/9 (3), and 42% (IQR 25%-50%) cores positive and a median time from high intensity focused ultrasound to radical prostatectomy of 22 months (IQR 7-26). Perioperative morbidity was limited to 1 transfusion in a patient with a rectal injury. Pathologically extensive periprostatic fibrosis was found with persistent prostate cancer, as pT3 disease (in 9 of 14), Gleason scores 6 (2), 7 (9) and 8 of 9 (4), with focally positive margins in 3 of 11 (pT3a). Postoperative prostate specific antigen was unrecordable in 14 of 15 patients with further treatment in 2. Postoperative continence (more than 12 months of followup) yielded no pad use in 6 of 10 men with universally poor erectile function., Conclusions: Radical prostatectomy as salvage is feasible for men in whom high intensity focused ultrasound failed, but with a higher morbidity than for primary surgery. Pathology results are alarming given the number of cases with extraprostatic extension yet early followup data suggest acceptable oncologic control. These results should be factored in when counseling men who wish to undergo primary high intensity focused ultrasound., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: We assessed pathological outcomes as well as the feasibility of combined docetaxel and androgen deprivation therapy in men with prostate cancer before undergoing prostatectomy., Materials and Methods: In this phase II multicenter study of newly diagnosed patients with untreated clinically localized prostate cancer and high risk features, all patients received androgen deprivation therapy (6.3 mg buserelin acetate every 8 weeks for 3 doses and antiandrogen for 4 weeks) with docetaxel (35 mg/m(2) weekly for 6 of 8 weeks for 3 doses)., Results: A total of 72 men with a median age of 59 years (range 46 to 78) were enrolled in the study. Baseline characteristics included clinical stage T1C, T2 or T3 in 14%, 47% and 39%, and Gleason score 7 or less, 8 and 9 in 40%, 29% and 31% of patients, respectively. Median baseline prostate specific antigen was 10.8 mug/l (range 1.6 to 65.6). Eight patients did not complete protocol therapy because of toxicity (4), withdrawal of consent (1) and other reasons (3). Of the 64 patients completing protocol therapy 2 had a complete pathological response. Pathological stage was T2 in 53% and T3 in 44% of patients. Four patients had N1 disease and positive surgical margins were identified in 27%. At a median followup of 42.7 months (range 25.6 to 65.6) 19 patients (30%) had disease relapse., Conclusions: Combined androgen deprivation and docetaxel before prostatectomy was feasible, and resulted in encouraging recurrence-free survival. While pathological down staging was observed, pathological complete response rates were rare.

Although nerve-sparing prostatectomy is widely practised, the results with respect to preserving potency often do not meet expectations. The concept of intraoperative cavernosal nerve stimulation is reasonable. Data that link the response to sildenafil after prostatectomy with bilateral nerve sparing has increased the importance of optimizing nerve sparing. The cavernosal nerves are often difficult to visualize and may have a variable course. A tumescent response to nerve stimulation can be shown consistently; the response may be subtle, and characterized by a minimal increase in penile circumference and blood flow. Immediately after prostatectomy, proximal nerve stimulation identifies whether neural continuity has been maintained, and is predictive of recovery of erectile function. The Cavermap system (Uromed Corporation, Boston, MA, USA) was developed to permit intraoperative nerve stimulation with tumescence monitoring. An initial phase 2 and subsequent phase 3 single-blinded, randomized, multicentre study that compared Cavermap-assisted prostatectomy with conventional nerve sparing showed a significant benefit in terms of the duration of nocturnal tumescence at 1 year. Other approaches are being explored, including incorporating the device into sural or genito-femoral nerve grafting, use of nerve stimulation during cystectomy or abdominal-perineal resection, and direct corpus cavernosal pressure monitoring during nerve stimulation. These approaches warrant further evaluation.

Objective: To evaluate whether there is any histologic progression from radical prostatectomy (RP) to local recurrence in patients with clinically isolated local recurrence following RP., Methods and Materials: A total of 43 patients with clinically isolated, biopsy proven, local recurrence following RP were retrospectively analyzed with respect to the change in Gleason score (GS) from RP to local recurrence. Central pathology review was undertaken for both RP and local recurrence biopsy specimens. The changes in primary and secondary Gleason grade (GG), and any potential correlation between the extent of GS change and other variables were also examined., Results: Median age at the time of local recurrence was 67 years (range: 55-78). Median interval between RP and local recurrence was 3.6 years (range: 0.3-17.7). Eight had a short course (<3 months) of hormone therapy prior to RP. Initial GS of RP specimens was 5, 6, 7, 8, and 9 in 1, 3, 29, 1, and 9 patients, respectively. At the time of local recurrence, GS was upgraded in 13, unchanged in 23, and downgraded in 7. The extent of GS change was correlated with the interval between RP and local recurrence, but not with pathological T stage or age., Conclusion: There was no statistically significant change in GS from RP to local recurrence, although there was a trend toward a higher GS at the time of local recurrence. The extent of GS change was associated positively with the elapsed time to local recurrence.

Purpose: In 1992 we initiated a national randomized prospective trial of 3 months of cyproterone acetate before radical prostatectomy compared to prostatectomy alone. Initial results indicated a 50% decrease in the rate of positive surgical margins. This decrease did not translate into a difference in prostate specific antigen (PSA) progression at 3 years. This report is on the long-term outcome (median followup 6 years) of this cohort., Materials and Methods: This prospective, randomized, open label trial compared 100 mg cyproterone acetate 3 times daily for 3 months before surgery to surgery alone. Randomization occurred between January 1993 and April 1994. Patients were stratified according to clinical stage, baseline serum PSA and Gleason sum. A total of 213 patients were accrued. Biochemical progression was defined as 2 consecutive detectable PSAs (greater than 0.2 ng/ml) at least 4 weeks apart, re-treatment or death from prostate cancer., Results: A total of 34 (33.6%) patients undergoing surgery only and 42 (37.5%) patients given neoadjuvant hormone therapy (NHT) had biochemical recurrence during the median followup of 6 years. Despite the significant pathological down staging in this study, there was no significant difference in number of patients with no evidence of biochemical disease (bNED) survival (p = 0.732). A bNED survival benefit favoring NHT was seen in men with a baseline PSA greater than 20 (p = 0.015)., Conclusions: After 6 years of followup there was no overall benefit with 3 months of NHT. Improved bNED survival was seen in the highest risk PSA group (PSA greater than 20). The possibility that high risk patients may benefit from NHT warrants further investigation.

Purpose: A prospective phase 3 trial was initiated to determine whether 8 compared with 3-month neoadjuvant hormonal therapy reduces prostate specific antigen (PSA) recurrence rates after radical prostatectomy. Our interim analysis includes secondary end points of differences in biochemistry, pathology and adverse events between the 2 groups., Materials and Methods: Men with clinically confined prostate cancer were randomized to receive 7.5 mg. leuprolide intramuscularly monthly and 250 mg. flutamide orally 3 times daily for 3 or 8 months before radical prostatectomy. Our study was powered to detect a 35% decrease in PSA recurrence, assuming a 30% recurrence rate in the 3-month arm after 3 years., Results: A total of 547 men were randomized between August 1995 and April 1998. Men in the 8 and 3-month groups were equally stratified for T stage (29% T1c, 70% T2), Gleason grade (68% less than 4, 32% 4 or greater) and pretreatment PSA (63% less than 10, 27% 10 to 20 and 10% greater than 20 microg./l.). Mean pretreatment PSA was slightly higher in the 8-month compared with the 3-month group (11.64 versus 9.95 microg./l., respectively, p = 0.0539). A total of 44 men withdrew from study before surgery and, therefore, were nonevaluable. Preoperative PSA nadir was less than 0.1 microg./l. in 43.3% versus 75.1% (p <0.0001), and 0.3 microg./l. or greater in 21% versus 9.2% after 3 versus 8 months, respectively (p <0.0006). Mean serum PSA decreased 98% to 0.12 microg./l. after 3 months, with a further 57% to 0.052 microg./l. from 3 to 8 months. Transrectal ultrasound determined that prostatic volume decreased 37% from a mean of 40.6 to 25.4 cc after 3-month neoadjuvant hormonal therapy (p = 0.0001) and a further 13% to 22.2 cc after 8 months (p = 0.03). Mean hemoglobin decreased 15% (148.2 to 125.4 gm./dl.) after 3-month neoadjuvant hormonal therapy but stabilized thereafter. Radical prostatectomy was completed in 500 men, while surgery was aborted intraoperatively in 3. Positive margin rates were significantly lower in the 8 than 3-month group (12% versus 23%, respectively, p = 0.0106). There were no fatal adverse events and no differences between the 2 groups in the severity or causality (p = 0.287, 0.0564) of adverse events, or incidence of increased liver enzymes or diarrhea (p = 0.691, 0.288, respectively). However, men in the 8-month group noticed a higher number of newly reported adverse events (4.5 versus 2.9, p <0.0001) and higher incidence of hot flushes than the 3-month group (87% versus 72%, respectively, p <0.0001)., Conclusions: Ongoing biochemical and pathological regression of prostate tumors occurs between 3 and 8 months of neoadjuvant hormonal therapy, suggesting that the optimal duration of neoadjuvant hormonal therapy is longer than 3 months. Longer followup is needed to determine whether longer therapy alters PSA recurrence rates.

Purpose: We determine if mapping of the cavernous nerve during radical prostatectomy using intraoperative cavernous nerve stimulation with tumescence monitoring results in improved erectile potency compared to conventional nerve sparing., Materials and Methods: A prospective, randomized, single blinded study was performed on 61 patients at 6 centers. Patients had elected to undergo nerve sparing prostatectomy and had normal preoperative erectile function documented by the Sexual Function Inventory Questionnaire (SFIQ) and RigiScan parallel testing. Patients were randomized between conventional nerve sparing and nerve sparing assisted by the CaverMap Surgical Aid. paragraph sign In all patients neural continuity was assessed immediately after prostate removal by proximal cavernous nerve stimulation. All patients were blinded according to their allocation cohort., Results: At 1 year there was substantial improvement in erectile function in the CaverMap group as measured by RigiScan. This group had a mean of 15. 9 minutes of greater than 60% nocturnal tumescence compared to 2.1 minutes in the conventional nerve sparing group (p <0.024). By SFIQ there was a nonsignificant trend to improved potency in the CaverMap group (71% versus 62%, p = 0.17). Of patients who had bilateral, unilateral and no response to stimulation after resection erectile function assessed by SFIQ recovered in 68%, 27% and 0%, respectively (p = 0.016)., Conclusions: CaverMap assisted prostatectomy led to improved erectile function as assessed by RigiScan testing with no associated adverse events. A response to stimulation immediately after removal of the prostate accurately predicted return of erectile function.

Purpose: The authors describe the experience of men with prostate cancer and their spouses in the early recovery period after surgery., Description of Study: As part of a longitudinal qualitative study, semistructured interviews were held with 34 patients who had prostate cancer and their spouses 8 to 10 weeks after surgery., Results: Five components of experience emerged from the interviews: 1) hearing news about the extent of their cancer after surgery influenced how patients viewed their cancer experience and, in many cases, their recovery; 2) men placed great emphasis on recovering their physical capacity quickly; 3) couples connected with each other through working out care routines and managing periods of irritability; 4) couples described a range of responses to surgery side effects and complications; and 5) the meaning of cancer varied for couples, with most seeing the experience as a temporary disruption., Clinical Implications: Physicians, nurses, social workers, and other health professionals working with patients before and after prostatectomies may assist couples to prepare better for the early recovery period by being both sensitive to the men's need to recover physical capacity quickly while helping them to understand that recovery takes time. Accurate information about expected periods of irritability, side effects, and possible complications would diminish the likelihood of distress during this period.

Although nerve-sparing prostatectomy is widely practiced, the results with respect to potency preservation often do not meet expectations. The concept of intraoperative cavernous nerve stimulation is rational. Recent data that link the response to sildenafil after prostatectomy to bilateral nerve sparing has increased the importance of optimizing nerve sparing. The cavernous nerves are often difficult to visualize and may have a variable course. A tumescent response to nerve stimulation can be consistently demonstrated. The response may be subtle, and characterized by a minimal increase in penile circumference and blood flow. Immediately after prostectomy, proximal nerve stimulation identifies whether neural continuity has been maintained, and is predictive of recovery of erectile function. A new device, the Cavermap, has been developed to permit intraoperative nerve stimulation with tumescence monitoring. An initial phase 2 and subsequent phase 3 single blinded, randomized, multicenter study that compared Cavermap-assisted prostatectomy with conventional nerve sparing demonstrated a significant benefit in terms of the duration of nocturnal tumescence by Rigiscan (Timm Medical Technologies, Eden Prairie, Minnesota) at 1 year. Other approaches are being explored, including sural nerve grafting, use of nerve stimulation during cystectomy or abdominal-perineal resection, and direct corpus cavernosum pressure monitoring during nerve stimulation. These approaches warrant further evaluation.

Considerable variation exists in the reported results of nerve-sparing prostatectomy with respect to potency preservation. This may reflect differences in surgical technique. The Cavermap is a device that uses intraoperative nerve stimulation with real time tumescence monitoring to permit identification of the course of the cavernous nerve fibers during radical prostatectomy. Results of a single center phase 2 and a blinded multicenter phase 3 study have demonstrated an improved outcome compared with conventional nerve sparing with respect to Rigiscan-measured nocturnal erection at 1 year after prostatectomy. The device permits evaluation of the success of nerve-sparing during surgery. Further studies of the effectiveness of the Cavermap device are warranted.

Objectives: To test the hypothesis that neoadjuvant androgen ablation before radical prostatectomy reduces the likelihood of biochemical progression at 36 months., Methods: Two hundred thirteen patients with localized prostate cancer were randomized to radical prostatectomy alone (Sx, n = 101) or a 12-week course of 300 mg of cyproterone acetate daily followed by surgery (CPA, n = 112). Biochemical progression (two consecutive detectable prostate-specific antigen [PSA] values) was determined for the entire group and by baseline PSA, Gleason score, clinical stage, and pathologic stage., Results: The probability of biochemical progression at 36 months was similar in both groups (CPA 40.2%, Sx 30.1%; P = 0.3233). CPA patients with baseline serum PSA between 25 and 50 ng/mL had a lower probability of biochemical progression (CPA 63.5%, Sx 84.6%; P = 0.0038). No difference in the probability of biochemical progression was seen between groups when analyzed by clinical stage or Gleason score. When analyzed by pathologic margin status, no difference was observed in the probability of biochemical progression in patients with organ-confined disease (P = 0.4484). There was a trend for a higher probability of progression in the neoadjuvant arm in patients with positive and negative surgical margins (P = 0.0105, P = 0.0459; alpha = 0.005 with Bonferroni adjustment)., Conclusions: Neoadjuvant androgen ablation with CPA reduces the positive margin rate significantly but does not result in a difference in biochemical progression at 3 years. This may be due to a lack of sufficient follow-up, insufficient power of the trial to demonstrate a small benefit, or a true lack of benefit of neoadjuvant androgen ablation before radical prostatectomy.

Objectives: To determine if intraoperative stimulation of the cavernous nerves while monitoring changes in penile tumescence to map the course of these nerves would result in an improvement in nerve sparing and erectile function after radical prostatectomy., Methods: Patients were eligible for this pilot study if they were undergoing a radical prostatectomy and were candidates for a nerve-sparing approach. Erectile function was assessed by patient self-reporting and questionnaire before surgery and by patient self-reporting periodically 12 months after surgery. A cavernous nerve stimulator and tumescence-monitoring device was used during radical prostatectomy to identify the course of the cavernous nerves and guide the surgeon in avoiding nerve damage. Patients were monitored for any evidence of complications and/or adverse events for 1 year from time of surgery., Results: Twenty-six patients were recruited to the trial. Nerve stimulation and tumescence monitoring was performed in 23 patients. Twenty-one of 23 patients demonstrated a tumescence response to intraoperative nerve stimulation. Nineteen of 21 patients reported erectile function preoperatively. Seventeen (89%) of 19 patients demonstrated a tumescence response during surgery. Sixteen (94%) of the 17 patients who demonstrated a response to nerve stimulation and for whom the surgery was guided by the tumescence response reported the ability to have erections after surgery. No side effects due to the use of the device were reported. Only 3 (12%) of 25 patients had positive margins confined to the lateral margin and/or apex whose modifications associated with nerve sparing could conceivably have altered margin status., Conclusions: These clinical data suggest that an intraoperative tumescence response to cavernous nerve stimulation may guide the surgeon in preserving cavernous nerves and improving erectile function after radical prostatectomy.

Purpose: This prospective randomized trial was used to compare predictive factors for organ confined margin negative status after radical prostatectomy with and without a 3-month course of neoadjuvant androgen withdrawal therapy., Materials and Methods: A total of 213 patients with localized adenocarcinoma of the prostate were randomized to radical prostatectomy with or without a 3-month course of 300 mg. neoadjuvant cyproterone acetate daily. Multivariate logistic regression analysis was used to determine significant predictors of organ confined margin negative status after radical prostatectomy in both groups. Parameters evaluated included baseline prostate specific antigen (PSA 4 or less, 4.1 to 10, greater than 10 ng./ml.), clinical stage (T2c versus T2b or less), biopsy Gleason score and percentage of surface area of biopsies involved with cancer. The multivariate analysis was repeated with PSA density and the natural logarithm of PSA to optimize the model., Results: In the radical prostatectomy alone arm a model incorporating only PSA density was the best predictor of organ confined margin negative status. In the neoadjuvant androgen withdrawal therapy arm a model incorporating biopsy Gleason score, PSA density and clinical stage was the best predictor., Conclusions: The conventional predictors of pathology at radical prostatectomy, biopsy Gleason score, PSA density and clinical stage retain significance as predictors in patients treated with a 3-month course of neoadjuvant androgen withdrawal therapy before radical prostatectomy.

Purpose: A prospective, multicenter, randomized study was done to test the hypothesis that neoadjuvant androgen withdrawal decreases the incidence of positive margins following radical prostatectomy for localized prostate cancer., Materials and Methods: Observations were made of 213 patients randomized to undergo radical prostatectomy alone (101) or to receive a 12-week course of 300 mg. cyproterone acetate daily followed by surgery (112). Groups were similar at baseline in terms of clinical stage, serum prostate specific antigen and Gleason score. Of 192 patients available for efficacy analysis 9 had stage T1b, 8 stage T1c, 63 stage T2a, 36 stage T2b and 76 stage T2c disease., Results: One or more positive surgical margins were found in 59 of 91 patients (64.8%) in the surgery only group compared to 28 of 101 (27.7%) in the cyproterone acetate group (p = 0.001). Patients who received preoperative therapy had a statistically significantly lower rate of apical margin involvement than those who did not (17.8 versus 47.8%, respectively, p < 0.0001). There was no statistically significant difference in surgical (p = 0.8645) or postoperative (p = 0.173) complications between the 2 groups., Conclusions: Neoadjuvant androgen withdrawal with a 12-week course of 300 mg. cyproterone acetate daily results in a lower rate of positive margins without adversely affecting postoperative recovery. The impact on patient survival will be determined by long-term followup.