Long-term survival and biomarker correlates of tasquinimod efficacy in a multicenter randomized study of men with minimally symptomatic metastatic castration-resistant prostate cancer.

PURPOSE: Tasquinimod (Active Biotech) is an oral immunomodulatory, anti-angiogenic, and anti-metastatic agent that delayed metastatic disease progression in a randomized placebo-controlled phase II trial in men with metastatic castration-resistant prostate cancer (mCRPC). Here, we report long-term survival with biomarker correlates from this trial. EXPERIMENTAL DESIGN: Two hundred and one (134 tasquinimod and 67 placebo) men with mCRPC were evaluated. Forty-one men randomized to placebo crossed over to tasquinimod. Survival data were collected with a median follow-up time of 37 months. Exploratory biomarker studies at baseline and over time were collected to evaluate potential mechanism-based correlates with tasquinimod efficacy including progression-free survival (PFS) and overall survival (OS). RESULTS: With 111 mortality events, median OS was 33.4 months for tasquinimod versus 30.4 months for placebo overall, and 34.2 versus 27.1 months in men with bone metastases (n = 136), respectively. Multivariable analysis demonstrated an adjusted HR of 0.52 [95% confidence interval (CI), 0.35-0.78; P = 0.001] for PFS and 0.64 (95% CI, 0.42-0.97; P = 0.034) for OS, favoring tasquinimod. Time-to-symptomatic progression was improved with tasquinimod (P = 0.039, HR = 0.42). Toxicities tended to be mild in nature and improved over time. Biomarker analyses suggested a favorable impact on bone alkaline phosphatase and lactate dehydrogenase (LDH) over time and a transient induction of inflammatory biomarkers, VEGF-A, and thrombospondin-1 levels with tasquinimod. Baseline levels of thrombospondin-1 less than the median were predictive of treatment benefit. CONCLUSIONS: The survival observed in this trial of men with minimally symptomatic mCRPC suggests that the prolongation in PFS with tasquinimod may lead to a survival advantage in this setting, particularly among men with skeletal metastases, and has a favorable risk:benefit ratio.

Open-label, clinical phase I studies of tasquinimod in patients with castration-resistant prostate cancer.

BACKGROUND: Tasquinimod is a quinoline-3-carboxamide derivative with anti-angiogenic activity. Two open-label phase I clinical trials in patients were conducted to evaluate the safety and tolerability of tasquinimod, with additional pharmacokinetic and efficacy assessments. METHODS: Patients with castration-resistant prostate cancer with no previous chemotherapy were enrolled in this study. The patients received tasquinimod up to 1 year either at fixed doses of 0.5 or 1.0 mg per day or at an initial dose of 0.25 mg per day that escalated to 1.0 mg per day. RESULTS: A total of 32 patients were enrolled; 21 patients were maintained for >or=4 months. The maximum tolerated dose was determined to be 0.5 mg per day; but when using stepwise intra-patient dose escalation, a dose of 1.0 mg per day was well tolerated. The dose-limiting toxicity was sinus tachycardia and asymptomatic elevation in amylase. Common treatment-emergent adverse events included transient laboratory abnormalities, anaemia, nausea, fatigue, myalgia and pain. A serum prostate-specific antigen (PSA) decline of >or=50% was noted in two patients. The median time to PSA progression (>25%) was 19 weeks. Only 3 out of 15 patients (median time on study: 34 weeks) developed new bone lesions. CONCLUSION: Long-term continuous oral administration of tasquinimod seems to be safe, and the overall efficacy results indicate that tasquinimod might delay disease progression.

Hand-assisted laparoscopic surgery (HALS) for live donor nephrectomy is more time- and cost-effective than standard laparoscopic nephrectomy.

BACKGROUND: Hand-assisted laparoscopy (HALS) was introduced to increase the safety of living donor nephrectomies. Herein we evaluate the first HALS living donor nephrectomies performed at our center. METHODS: Traditional laparoscopic nephrectomies (TLS) (n = 11) and HALS nephrectomies (n = 11) were included in the study. One patient from the TLS group was excluded because the operation was converted to open nephrectomy. We compared the operating times (OT) and warm ischemia times (WIT) for the two procedures and calculated the operating costs. RESULTS: Mean OT was 270 min in the TLS group and 197 min in the HALS group; thus, there was, a significant reduction of 27% with HALS. WIT was 297 sec for the TLS group and 214 sec for the HALS group, for a reduction of 28%. Costs were also lowered for HALS. CONCLUSION: In addition to shortening both OT and WIT, HALS enhances the safety margin of the procedure, especially during trocar placement. It is further helpful in preventing torsion of the kidney and controlling potential bleedings, as well as during vascular stapling and kidney removal.

Postoperative radiotherapy after prostatectomy can be associated with severe side effects.

This retrospective study was initiated to evaluate the efficacy and side effects of post-prostatectomy external beam radiation therapy (XRT) with a short time interval between surgery and irradiation in patients with prostate adenocarcinoma. Sixteen patients were investigated. The overall results in this study were 3 deaths due to recurring disease and two relapses after an average follow-up of 60 months. Severe side effects were observed. Two patients required surgical intervention due to severe post-radiotherapy side effects. The reason for this could be the high dose delivered to peripheral organs and/or a too short time interval between surgery and postoperative XRT. The results of this study confirmed that postoperative XRT can improve local control frequency in prostate carcinomas. It is recommended that the time interval between surgery and postoperative radiotherapy should to be 3-6 month.

Clinical management of premalignant lesions of the prostate. WHO Collaborative Project and Consensus Conference on Public Health and Clinical Significance of Premalignant Alterations in the Genitourinary Tract.

The presence of high-grade prostatic intraepithelial neoplasia (PIN) in a prostate biopsy is a considerable risk factor for the presence of prostate cancer, with up to 73% of patients having cancer on rebiopsy. The risk is related to the clinical setting (screening vs urological practice) and patient factors such as prostatic serum antigen (PSA) and findings on digital rectal examination (DRE). Thus, high-grade PIN has serious clinical implications. The aim of this paper is to propose practical guidelines for the clinical management of PIN. Based on current knowledge we recommend that: Only patients considered for curative treatment of prostate cancer be further investigated for a PIN biopsy finding; A palpable nodule or tumor-suspicious transrectal ultrasonography (TRUS) finding, in conjunction with a finding of high-grade PIN on prostate biopsy, should prompt rebiopsy; An elevated PSA level or an elevated PSA density should also warrant repeat biopsy, as the most likely cause of PSA elevation is concomitant prostate cancer; The presence of high-grade PIN on biopsy without concomitant prostate cancer in patients suitable for curative treatment, notwithstanding normal DRE, TRUS or PSA, should prompt repeat biopsies, as the association with prostate cancer is significant; The presence of PIN alone on biopsy does not warrant treatment, as a substantial number of rebiopsies yield only PIN.

[Laparoscopic living-donor nephrectomy. A small study shows positive results, but the procedure still lacks satisfactory evaluation]. / Laparoskopisk nefrektomi från levande givare. Liten studie visar positiva resultat, men tekniken ännu ej tillräckligt utvärderad.

Retrospective analysis and comparison of a small series of 12 laparoscopic live donor nephrectomy (LapLDN) procedures with 15 open live donor nephrectomies, all 27 performed in 1998, showed operating time to be significantly longer but sick leave shorter and hospital stay somewhat shorter in the LapLDN subgroup. One patient in the open procedure subgroup developed herniation and scar discomfort, and in one LapLDN procedure severe bleeding necessitated conversion to open nephrectomy. All kidneys in both subgroups manifested immediate resumption of function after transplantation. Though the LapLDN procedure has yet to be satisfactorily evaluated, the present findings were predominantly in its favour.

[Comparison among patients considered candidates for radical prostatectomy in academic institutes in different countries]. / Comparación entre pacientes considerados candidatos para prostatectomía radical en instituciones académicas de distintos países.

OBJECTIVE: Radical prostatectomy is performed in potentially curable prostatic cancers, but surgical indication might somehow depend on the idiosyncrasies of a population. Herein we compare the characteristics of patients undergoing radical prostatectomy in teaching University Hospitals of different countries. METHODS: We conducted a retrospective review on 250 consecutive patients who underwent radical prostatectomy before January 1997 in five teaching University Hospitals in Europe (Spain, Sweden, Switzerland, Turkey) and the United States (Detroit, MI). Clinicopathological data were recorded and compared, and a questionnaire investigated whether patient and physician attitudes towards surgery differed. RESULTS: The number of surgeries per month at each institution ranged from 0.9 to 10 and the proportion of newly diagnosed patients that undergo surgery from 0.14 to 0.36. The Kruskal-Wallis test revealed both median age and preoperative prostate-specific antigen (PSA) levels were different between groups. Similarly, despite standardized surgery and histologic work-up, differences in the detection of extracapsular invasion and the rate of detectable PSA after surgery were observed between institutions. Diagnosis in the Swedish and Swiss groups was more often based on digital rectal examination, while the rest were more confident with transrectal ultrasound. Doctors at some institutions were more inclined to recommend radical surgery, either by not mentioning or disapproving other therapeutic strategies. The proportion of patients who said they would elect surgery again ranged from 72% to 92%, and the proportion of doctors who said they would perform surgery again ranged from 78% to 100%. Patients' and doctors' degree of satisfaction with the decision made were also different. CONCLUSIONS: (i) Candidates for radical prostatectomy in teaching hospitals of several countries are different. Might therefore have practical implications on the design of clinical trials and the interpretation of the results of treatment. (ii) Patient and physician acceptance of surgery varies according to countries and is more established firm in those countries where it is more frequently performed.

Interference pattern in the urethral sphincter: a quantitative electromyographic study in patients before and after radical retropubic prostatectomy.

OBJECTIVE: Radical retropubic prostatectomy (RRP) involves removal of the bladder neck where the proximal urethral sphincter is located. Assuming that this sphincter participates in urinary continence mechanisms, removal of this sphincter might increase the interference pattern in the distal urethral sphincter as a compensatory mechanism. MATERIAL AND METHODS: We examined the distal (striated) urethral sphincter before and after surgery with quantitative EMG techniques in ten patients. RESULTS: No compensatory activity was demonstrated, but tendencies towards a decreased number of turns at rest (41 pre-op/27 post-op) and an increased mean amplitude at maximal activation (334 microV pre-op/408 microV post-op) in the interference pattern in the muscle were recorded using the turns/amplitude (T/A) analysis. The fibre density was 1.71 before and 1.96 after surgery (p = 0.08), indicating a peripheral nerve lesion. CONCLUSIONS: The numerical reduction of turns during rest can be explained by disturbed feedback, indicating that not only efferent, but also sensory afferent nerve fibres can be involved in an iatrogen lesion during prostatic surgery. The increased mean amplitude at maximal activation was probably due to reinnervated motor units with increased amplitudes.

Precancer of the prostate.

The evolution of the malignant phenotype requires a set of genetic and epigenetic changes in sets of genes responsible for regulation of normal growth and cell death, of "social behaviour" and differentiation. The sum of these changes, not only the sequence, determines the malignancy as well as its grade. The probability of invasiveness shows a remarkable relationship to morphological changes, which in turn prove to be accompanied by a multitude of discrete molecular perturbations. Some of these can be characterized as functional, others as inductive with respect to their participation in the process. Since only the functional changes regulate malignant behaviour per se, it is an important task for future research to assemble a set of such changes, find markers for them and combine morphological and molecular indicators to achieve prognostically optimal scores. It should be emphasized, though, that rational use of such scores using biopsy samples as a source of information cannot be defined until biopsy strategies have been standardized and optimized.

Morphometric studies of intra-prostatic volume relationships in localized prostatic cancer.

OBJECTIVES: To further characterize patterns of tumour growth and the distribution of markers for the aggressiveness of prostate cancer by assessing the relationships among the volume of the 'index' tumour and that of the remaining foci, with pathological (pT) stage, histological grade and DNA ploidy, and with the amount of low- and high-grade prostatic intraepithelial neoplasia (PIN). MATERIALS AND METHODS: Eighty-eight step-sectioned total prostatectomy specimens were analysed. The Gleason score, tumour stage and DNA ploidy (by flow cytometry) of multiple samples were determined. Tumour and PIN areas were outlined and their volumes estimated by computerized planimetry. RESULTS: The pT stage, Gleason sum and DNA nondiploidy increased, and PIN volumes decreased, with increasing volume of the index tumour focus (P < 0.01), but did not differ significantly between uni- and multifocal tumours. However, PIN volumes were significantly larger in multifocal cases with an index tumour volume of > 3 mL than in unifocal tumours > 3 mL (P < 0.05). Small volume, unifocal tumours had little PIN. The most malignant features of each case were always represented in the index tumour but not generally in the remaining foci. CONCLUSIONS: The volume distribution, related to multicentricity and its concomitant PIN volumes, indicates that large index tumours, uni- or multifocal, of medium or high grade, are associated with low PIN volumes. However, multifocal medium- and high-grade tumours with small index tumour volumes have higher PIN volumes. Small, single tumours are of low-grade and may represent the slowly progressing cancers possibly resembling those found in autopsy studies.

Allelic loss of 8p sequences in prostatic intraepithelial neoplasia and carcinoma.

OBJECTIVES: Previous work has suggested that prostatic intraepithelial neoplasia (PIN) may be a premalignant lesion important in tumorigenesis of the prostate. However, to adequately test this hypothesis at the genetic level, it is necessary to determine whether lesions in close proximity demonstrate similar genetic alterations and, hence, whether an "evolutionary" relationship might exist between PIN and tumor in the same prostate. Therefore, the purpose of this study was to examine at least two PIN lesions per prostate (one adjacent to and another distant from malignant lesions in the same prostate) for similarities or differences in the types and frequencies of genetic alterations. METHODS: To accomplish this goal, DNA was extracted from microdissected PIN, tumor, and normal epithelial tissue samples from 48 radical prostatectomies and amplified using polymerase chain reaction techniques at highly polymorphic microsatellite repeat sequences at proximal (D8S87, 8p12) and distal (NEFL, 8p21) loci on the short arm of chromosome 8. PIN specimens were either adjacent to (within one high-power microscopic field [HPF]) or distant from (separated by two or more HPFs) tumor specimens from the same patients. RESULTS: Similar fractional allelic loss frequencies were observed for informative tumor (10 [35%] of 29) and PIN (6 [21%] of 29) samples at the NEFL locus, but allelic loss at the D8S87 locus was observed only in tumors (8 [22%] of 36 informative samples). Moreover, allelic loss at the NEFL locus involved the same allele in 4 cases and different alleles in 3 cases. Interestingly, all 4 cases with the same allele loss were from adjacent PIN and tumor tissues, and all 3 with different allele loss were from distant PIN and tumor. CONCLUSIONS: These results suggest that PIN and invasive cancer share common genetic events (eg, deletion at the NEFL locus) along the same pathway of development in the prostrate.

The relationship between prostatic intraepithelial neoplasia and prostate cancer: critical issues.

PURPOSE: Prostatic intraepithelial neoplasia (PIN) is often considered to be a premalignant lesion and the main precursor of invasive carcinoma of the prostate. We evaluated the evidence for and against PIN as a premalignant lesion and determined guidelines for the clinical management of PIN. MATERIALS AND METHODS: Literature analysis of histopathological, morphometric, phenotypic and molecular genetic evidence of progression and of clinical findings regarding PIN was done. Literature searches were performed on MEDLINE with relevant key words. RESULTS: PIN, like prostate cancer, occurs most frequently in the peripheral zone of the prostate and is usually located in close proximity to prostate cancer. The relative PIN and prostate cancer volumes vary inversely. Prostate specific antigen in cases of PIN appears to be intermediate between prostate cancer and normal levels, although this elevation may be explained by concomitant prostate cancer or benign prostatic hyperplasia. Deoxyribonucleic acid ploidy in PIN follows the aneuploid proportion as in the concomitant prostate cancer. Prostate cancer and PIN show evidence of loss of putative tumor suppressor genes on chromosome 8p. The clinical relevance of PIN biopsy findings is based on the association of neoplasia and prostate cancer. High grade PIN in core biopsies without concomitant prostate cancer has a substantial risk for prostate cancer in subsequent biopsies (24 to 73%, up to 100% when the digital rectal examination is suspicious) and should cause further biopsy sampling. CONCLUSIONS: There is convincing evidence that PIN is a precursor lesion to prostate cancer, with a close association of PIN and prostate cancer in biopsy and prostatectomy specimens. A biopsy finding of high grade PIN necessitates further investigation in patients who are candidates for radical treatment for localized prostate cancer.

Neo-adjuvant GnRH therapy and radical prostatectomy: effects on tumorous and benign tissue volumes - a morphometric study.

UNLABELLED: The effect on tumour and prostate volumes of a 3-month course of neo-adjuvant hormone therapy was studied using computerised planimetry on serially sectioned specimens obtained by radical prostatectomy. Fifty-four specimens from patients not receiving pre-treatment were compared to 38 specimens from patients given the gonadotropin-releasing hormone (GnRH) analogue triptorelin for 3 months before the operation. Glandular volume and volume of the index tumour was determined. To determine the position of the index tumour within the gland, the centre of mass of the tumour was identified and the distance to the gland margin calculated. This value (M1) represents the sum of the tumour radius and the various amounts of normal tissue. The amount of surrounding tissue could be approximated by correlating M1 to the corresponding tumour volume. RESULTS: The two groups differed significantly in total gland volumes, but not in tumour volumes. M1 was strongly correlated to the tumour volume in the treatment group (r = 0.73), whereas in the control group the correlation was found to be significantly weaker (r = 0.44), indicating that there was less tissue surrounding the tumour in the pre-treated group. In a multiple regression analysis of all 92 patients, index tumour volume was found to be associated with total gland volume, DNA ploidy pattern, tumour grade but not whether or not pre-treatment was given. This study found that the volumes of the single largest tumour focus were not significantly affected by hormonal pre-treatment, and that "the prostate condenses around the tumour rather than that the tumour shrinks back into the prostate". However, the precise relationship between tumour epithelial volume and stroma with or without neo-adjuvant hormonal pre-treatment remains to be clarified.

Urinary incontinence and sexual impotence after radical prostatectomy.

Telephone interviews concerning urinary continence and sexual potency in 152 men who had undergone radical prostatectomy for localized cancer were conducted by an investigator who had not been involved in the patients' treatment. The obtained data were compared with the surgeons' recorded follow-up notes. Continence was defined according to ICS criteria and potency as the capacity for vaginal penetration. At the interviews, 74 men (49%) reported total continence and 39 others (26%) were acceptably dry; 32 required more than two small protective pads per day, five had received an artificial sphincter implant and two had supravesical urinary diversion (Kock pouch), making 39 (25%) classified as incontinent. The surgeons' records, however, showed an 89% continence rate and 87% of these men had regained continence within 24 weeks of the operation. Of 134 preoperatively potent men, only 21 (14%) remained potent in the first postoperative year. That earlier reported excellent results regarding continence and potency were not reproduced in our study, possible was partly due to our inclusion of more advanced tumours in somewhat older patients, but the fact that the interviewer was independent of the surgeon significantly influenced the results.

A 3-year follow-up of patients with localized prostate cancer operated on with or without pre-treatment with the GnRH-agonist triptorelin.

OBJECTIVE: To examine the effect of pre-operative androgen deprivation on the progression rate of malignancy in patients operated on for localized prostate cancer. PATIENTS AND METHODS: A total of 53 patients received no hormone therapy (group 1) and a further 38 patients (group 2) received the generic releasing-hormone agonist triptorelin during the 3 months before surgery. The patients in group 1 had T1b-T2 tumours, whereas 12 of those in group 2 had clinical stage T3 tumours. Despite this, the surgical specimens from the patients in group 2 showed a rate of cancer invasion of the surgical margins 20% lower than those from the patients in group 1. After prostatectomy, the patients were followed for 3 years by repeated analyses of prostate-specific antigen (PSA) in serum. RESULTS: During the follow-up, the PSA level exceeded the upper threshold (0.6 ng/mL) in 16% of the patients in group 1 and in 43% of those in group 2 (P < 0.05). This difference was mainly related to the pre-treatment stage of the tumor. Some of the patients in group 1 received post-operative radiotherapy but this was not reflected in their PSA levels. Of the patients in group 1 and 2, 4% and 14% respectively (P > 0.05), developed symptoms from skeletal metastases. CONCLUSION: There was no evidence that pre-operative hormone therapy slowed the progression of prostate cancer.

DNA ploidy patterns in androgen-deprived localized prostate cancer.

Prostatectomy was performed in 48 patients with localized prostate cancer. Before surgery, they had been treated with the GnRH agonist triptorelin for 3 months. Specimens from the largest tumor focus (n = 6.3 + 3.6, mean + SD) were analyzed with regard to the DNA ploidy pattern. The results were compared with those obtained in a previous investigation of 54 patients who were subjected to surgery without hormone pretreatment. In both series, about 50% of the tumors showed a diploid DNA ploidy pattern, the rest being nondiploid. Ploidy heterogeneity, i.e., a mixture of diploid and nondiploid ploidy patterns in the single largest tumor focus, was found in 36% of the cases compared to 48% in the previous report (NS). In 13% of the tumors, all samples revealed a nondiploid DNA ploidy pattern as compared to 6% in the previous report (NS). In both series, needle biopsy examination (1/patient) prior to prostatectomy was associated with a significant and similar underestimate of the chromosomal aberration. In conclusion, despite the marked histopathological changes previously reported, there is no evidence that neoadjuvant triptorelin treatment during 3 months has any effect on the DNA ploidy pattern.

Multiple transrectal ultrasound-guided biopsies for the detection of prostate cancer and determination of tumor volume, grade, and seminal vesicle invasion.

A total of 251 men with suspected prostate cancer were examined by transrectal ultrasound (TRUS) in order to evaluate the usefulness of TRUS and core biopsies for the detection of prostate cancer and determination of tumor volume, grade, and seminal vesicle invasion (SVI). Biopsies targeting hypoechoic lesions were taken in combination with systematic biopsies obtained from six standardized locations. Bilateral seminal vesicle biopsies were obtained from 168 of the men. A total of 26 patients underwent surgery and a comparison between the results of the histopathological evaluation of core biopsies and the prostatectomy specimen was performed. A total of 137 cancers were detected. In 34 patients (25%) the tumors were diagnosed by systematic biopsies alone. Tumor volume as estimated by TRUS underestimated the volume when compared to a planimetric technique. Correlation between the two methods was not found by regression analysis. Systematic biopsies did not improve grading compared to the grading of prostatectomy specimens. A total of 24 SVIs were detected. Valuable information was obtained for the diagnosis of prostate cancer by taking systematic biopsies.

Determinants of complications after multiple transrectal core biopsies of the prostate.

Transrectal ultrasound-guided biopsies of the prostate were performed on 347 consecutive men. All patients were given prophylactic antibiotics. The first 199 patients received 400 mg norfloxacin immediately after the biopsies were performed and 400 mg the same evening. The second group of 148 patients received 400 mg of norfloxacin 1 h before the examination followed by five doses administered twice daily. A total of 15 major complications were noted. In the first group the complication rate was 6.5% and in the second group 1.4%. The different regimes of prophylactic antibiotic treatment were the only parameters shown to have a statistically significant impact on the complication rate. The number of complications decreased, but were not eliminated, when prophylactic treatment with norfloxacin was given before the biopsies were taken and continued for a total of 3 days.

Adverse effects after radical external beam radiotherapy of localized prostatic adenocarcinoma using two-dimensional dose-planning and a limited field technique.

Adverse effects were assessed after definitive limited field, 2-dimensional CT-planned radiation treatment of localized prostatic adenocarcinoma. In 66 surviving patients, out of a total of 176 treated patients, personal interviews were performed and self-administered questionnaires distributed. The average follow-up was 6.6 years. Adverse effects with regard to bowel function and micturition were investigated, and graded 0-4 with increasing severity and impact on performance status, essentially according to the RTOG toxicity scoring system. Sexual functions were registered on visual analogue scales. The majority of adverse effects were considered minor (grade 1) and did not require any treatment. Late adverse effects on bowel and bladder or urethra that required treatment (grade 2-4) were reported in up to 8% (n = 5) of cases respectively. Late bowel side-effects that interfered with life style (grade 3-4) occurred in up to 3% (n = 2) of patients; the majority were rectal complications. Corresponding urinary side-effects were registered in up to 6% (n = 4) of the patients. Major surgical interventions were not required. Sexual functions were substantially affected in 60% of cases not administered endocrine treatment. Multivariate analyses could not identify patient or treatment risk factors related to complications.

Rectal perforation after retropubic radical prostatectomy: occurrence and management.

OBJECTIVES: A surgical audit of the management of rectal perforations during retropubic radical prostatectomy. Assessment of incidence, risk factors, management and outcome. METHODS: All 10 cases (3.6%) sustaining a rectal injury of a total series of 270, while undergoing retropubic radical prostatectomy at our 2 institutions were reviewed. In all cases, the injury was immediately recognized and treated by primary suture, anal dilatation and antibiotics. In 1 case, a temporary colostomy was performed. RESULTS: Recovery was uneventful in all cases, and the postoperative hospitalization was only slightly longer than usual in the 9 cases without fecal diversion. No fistulae or wound infections occurred, but closure of 1 colostomy was complicated. CONCLUSION: Provided that the injury is promptly recognized and properly sutured, a rectal perforation at radical prostatectomy is not of great significance and should not deter from an adequate preoperative investigation by multiple transrectal core biopsies or neoadjuvant hormonal treatment. The use of preoperative bowel preparation, routine antibiotic prophylaxis, omental interposition or a proximal colostomy does not appear to be necessary in order to achieve immediate safe repair.