[Why outpatient surgery does not work in hospitals - or medical practices - as yet]. / Ambulantes Operieren: Warum es im Krankenhaus (noch) nicht klappt ­ und in der Praxis auch nicht.

High costs in the German health care system and a lack of nursing staff make a shift from inpatient to outpatient treatment unavoidable. The new catalogue announced for outpatient surgical procedures will contain up to 50% of all procedures in urology. In anticipation of these major changes, neither hospitals nor medical practices are able to prepare adequately since the precise catalogue, the infrastructural changes required, and the rules of remuneration have not yet been clarified. Without some degree of certainty for planning, nobody will be able or willing to invest into future structures.

Low-dose rate brachytherapy for men with localized prostate cancer.

BACKGROUND: Localized prostate cancer is a slow growing tumor for many years for the majority of affected men. Low-dose rate brachytherapy (LDR-BT) is short-distance radiotherapy using low-energy radioactive sources. LDR-BT has been recommended for men with low risk localized prostate cancer. OBJECTIVES: To assess the benefit and harm of LDR-BT compared to radical prostatectomy (RP), external beam radiotherapy (EBRT), and no primary therapy (NPT) in men with localized prostatic cancer. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (from 1950), and EMBASE (from 1980) were searched in June 2010 as well as online trials registers and reference lists of reviews. SELECTION CRITERIA: Randomized, controlled trials comparing LDR-BT versus RP, EBRT, and NPT in men with clinically localized prostate cancer. DATA COLLECTION AND ANALYSIS: Data on study methods, participants, treatment regimens, observation period and outcomes were recorded by two reviewers independently. MAIN RESULTS: We identified only one RCT (N = 200; mean follow up 68 months). This trial compared LDR-BT and RP. The risk of bias was deemed high. Primary outcomes (overall survival, cause-specific mortality, or metastatic-free survival) were not reported. Biochemical recurrence-free survival at 5 years follow up was not significantly different between LDR-BT (78/85 (91.8%)) and RP (81/89 (91.0%)); P = 0.875; relative risk 0.92 (95% CI: 0.35 to 2.42).For severe adverse events reported at 6 months follow up, results favored LDR-BT for urinary incontinence (LDR-BT 0/85 (0.0%) versus RP 16/89 (18.0%); P < 0.001; relative risk 0) and favored RP for urinary irritation (LDR-BT 68/85 (80.0%) versus RP 4/89 (4.5%); P < 0.001; relative risk 17.80, 95% CI 6.79 to 46.66). The occurrence of urinary stricture did not significantly differ between the treatment groups (LDR-BT 2/85 (2.4%) versus RP 6/89 (6.7%); P = 0.221; relative risk 0.35, 95% CI: 0.07 to 1.68). Long-term information was not available.We did not identify significant differences of mean scores between treatment groups for patient-reported outcomes function and bother as well as generic health-related quality of life. AUTHORS' CONCLUSIONS: Low-dose rate brachytherapy did not reduce biochemical recurrence-free survival versus radical prostatectomy at 5 years. For short-term severe adverse events, low-dose rate brachytherapy was significantly more favorable for urinary incontinence, but radical prostatectomy was significantly more favorable for urinary irritation. Evidence is based on one RCT with high risk of bias.

Permanent interstitial low-dose-rate brachytherapy for patients with localised prostate cancer: a systematic review of randomised and nonrandomised controlled clinical trials.

CONTEXT: Prostate cancer (PCa) is the most common cancer in men. Permanent interstitial low-dose-rate brachytherapy (LDR-BT) is a short-distance radiation therapy in which low-energy radioactive sources are implanted permanently into the prostate. OBJECTIVE: To assess the effectiveness and safety of LDR-BT compared to treatment alternatives in men with localised PCa. EVIDENCE ACQUISITION: Bibliographic databases (Medline, Embase, and the Cochrane Library) were searched from inception until June 2010 for randomised and nonrandomised controlled trials comparing LDR-BT with radical prostatectomy (RP), external-beam radiation therapy (EBRT), or no primary therapy (NPT). Primary outcome was overall survival (OS). Secondary outcomes were disease-free survival (DFS), biochemical recurrence-free survival (bRFS), physician-reported severe adverse events (SAE), and patient-reported outcomes (PRO). EVIDENCE SYNTHESIS: A total of 31 studies, including 1 randomised controlled trial (RCT), were identified. Risk of bias was high for all 31 studies. OS was reported in one nonrandomised controlled study; however, these data were not interpretable because of strong residual confounding. DFS was not reported. Comparison of bRFS between treatment groups is not validated; thus, results were not interpretable. Physician-reported urogenital late toxicity grade 2 to 3 was more common in the LDR-BT group when compared to the EBRT group. With respect to PRO, better scores for sexual and urinary function as well as urinary incontinence were reported for LDR-BT compared to RP. Better scores for bowel function were reported for LDR-BT compared to EBRT. CONCLUSIONS: We found a low amount of evidence in studies that exclusively compared LDR-BT with other treatment modalities. LDR-BT may have some different physician-reported SAE and patient-reported outcomes. The current evidence is insufficient to allow a definitive conclusion about OS. Randomised trials focusing on long-term survival are needed to clarify the relevance of LDR-BT in patients with localised PCa.

Prostate-specific antigen kinetics following external-beam radiotherapy and temporary (Ir-192) or permanent (I-125) brachytherapy for prostate cancer.

BACKGROUND AND PURPOSE: The aim of the study was the evaluation of PSA kinetics after different radiotherapy methods. MATERIALS AND METHODS: Two-hundred and ninety five patients received external-beam radiotherapy (EBRT; 70.2 Gy; n=135), Ir-192 brachytherapy as a boost to EBRT (HDR-BT; 18 Gy+50.4 Gy; n=66) or I-125 brachytherapy (LDR-BT; 145 Gy; n=94) as monotherapy. "PSA bounce" was defined as a PSA rise of > or = 0.2 ng/ml followed by spontaneous return to prebounce level or lower, biochemical failure as "nadir+2 ng/ml". RESULTS: Patients without biochemical failure reached a lower nadir after brachytherapy (median < or = 0.05 ng/ml after LDR- and HDR-BT without NHT) in comparison to EBRT (0.55 ng/ml without NHT; p<0.01). Not a single patient without NHT and a nadir <0.1 ng/ml failed biochemically (0% vs. 45% with a nadir > or = 0.1 ng/ml; p<0.01). PSA bounces were found predominantly in the LDR-BT group (42% vs. 23%/20% after HDR-BT/EBRT; p<0.01). In a multivariate Cox regression analysis, LDR-BT and HDR-BT were associated with a significantly lower biochemical failure rate in comparison to EBRT. CONCLUSIONS: PSA kinetics differ significantly following different radiotherapy methods. A lower nadir and a higher biochemical control rate suggest a higher radiobiological efficiency of brachytherapy in comparison to EBRT (with a dose of 70.2 Gy).

Rectal morbidity after permanent interstitial brachytherapy for prostate cancer--impact of day 1 vs. day 30 computed tomography-based postimplant dosimetry.

PURPOSE: The aim of the study was to evaluate bowel quality-of-life changes after prostate brachytherapy and the impact of Day 1 vs. Day 30 postimplant dosimetry. METHODS AND MATERIALS: In 61 patients, computed tomography (CT) scans were performed at Days 1 and 30 after (125)I brachytherapy. The patients have been surveyed prospectively before (time A), 1 month (time B), and >1 year after treatment (time C) using a validated questionnaire (Expanded Prostate Cancer Index Composite). Different parameters were tested for their predictive value on bowel quality-of-life changes (bowel bother score decrease >20 points at time B=BB20; bowel bother score decrease >10 points at time C=BC10), including seed displacements. RESULTS: Mean bowel function/bother score decreased 13/13 points at time B (p<0.01) and 1/4 points at time C (change not significant). BB20 and BC10 were found in 25% and 20% of patients, respectively. Bowel bother score declines at time B correlated well with declines at time C (r=0.53; p<0.01). Prostate volume before implantation and the number of seeds per cubic centimeters were found to be predictive for BB20 and BC10. Smaller rectal wall volumes covered by the 60-100% isodoses at Day 1 were (paradoxically) found to be significantly predictive for BC10. Larger posterior seed displacements between Days 1 and 30 were significantly associated with BB20. CONCLUSIONS: Quality-of-life scores have not been found to change significantly >1 year after brachytherapy. Larger rectal wall volumes within higher isodoses at Day 1 or 30 were not found to be predisposing for adverse quality-of-life changes.

Impact of age and comorbidities on health-related quality of life for patients with prostate cancer: evaluation before a curative treatment.

BACKGROUND: Interpretation of comparative health-related quality of life (HRQOL) studies following different prostate cancer treatments is often difficult due to differing patient ages. Furthermore, age-related changes can hardly be discriminated from therapy-related changes. The evaluation of age-and comorbidity-related changes was in focus of this study. METHODS: HRQOL of 528 prostate cancer patients was analysed using a validated questionnaire (Expanded Prostate Cancer Index Composite) before a curative treatment. Patients were divided into age groups 75 years. The impact of specific comorbidities and the Charlson Comorbidity Index (CCI) were evaluated. The questionnaire comprises 50 items concerning the urinary, bowel, sexual and hormonal domains for function and bother. For assessment of sexual and hormonal domains, only patients without prior hormonal treatment were included (n = 336). RESULTS: Urinary incontinence was observed increasingly with higher age (mean function scores of 92/88/85/87 for patients 75 years) complete urinary control in 78%/72%/64%/58% (p < 0.01). Sexual function scores decreased particularly (48/43/35/30), with erections sufficient for intercourse in 68%/50%/36%/32% (p < 0.01) a decrease of more than a third comparing patients 75 years; p < 0.05). A multivariate analysis revealed an independent influence of both age and comorbidities on urinary incontinence, specifically diabetes on urinary bother, and both age and diabetes on sexual function/bother. Rectal domain scores were not significantly influenced by age or comorbidities. A CCI>5 particularly predisposed for lower urinary and sexual HRQOL scores. CONCLUSION: Urinary continence and sexual function are the crucial HRQOL domains with age-related and independently comorbidity-related decreasing scores. The results need to be considered for the interpretation of comparative studies or longitudinal changes after a curative treatment.

Rectourethral fistula following LDR brachytherapy.

Modern LDR brachytherapy has drastically reduced rectal toxicity and decreased the occurrence of rectourethral fistulas to <0.5% of patients. Therefore, symptoms of late-onset sequelae are often ignored initially. These fistulas cause severe patient morbidity and require interdisciplinary treatment. We report on the occurrence and management of a rectourethral fistula which occurred 4 years after (125)I seed implantation.

Rectal dosimetry following prostate brachytherapy with stranded seeds--comparison of transrectal ultrasound intra-operative planning (day 0) and computed tomography-postplanning (day 1 vs. day 30) with special focus on sources placed close to the rectal wall.

BACKGROUND AND PURPOSE: The aim of the study was to compare intra-operative and postplanning at different intervals with special focus on sources placed close to the rectal wall. MATERIALS AND METHODS: In 61 consecutive patients, CT scans were performed on day 1 and day 30 after an I-125 implant with stranded seeds. The number of sources < or =7 mm to the rectal wall was determined, and displacements were analyzed. The angulation of strands relative to rectal wall was compared between intra-operative transrectal ultrasound (TRUS) and both postplanning CT scans. RESULTS: Sources close to the rectum on day 1 (n=204) have been the most apical in a strand in 98.5% (n=201). By comparing day 1 and day 30 data, significant inferior source displacements (mean 3.6 mm; p=0.02) relative to pelvic bones and a decreasing distance to the rectal wall (mean 1.2 mm; p<0.01)--consequentially increasing rectal dose--were determined only for sources initially > or =3 mm to the rectum. In contrast to an almost parallel arrangement of the needle track and the rectal wall in TRUS, strands and rectal wall converged towards the apex in the postplanning CT scans (mean >30 degrees). CONCLUSIONS: Posterior preplanning margins around the prostate should be particularly limited at the level of the prostate apex.

Health-related quality of life after permanent I-125 brachytherapy and conformal external beam radiotherapy for prostate cancer--a matched-pair comparison.

BACKGROUND AND PURPOSE: The aim of the study was to compare quality of life after permanent I-125 brachytherapy (BT) and external beam radiotherapy (EBRT) for prostate cancer. MATERIALS AND METHODS: A group of 104 patients (52 in each group) have been surveyed prospectively before EBRT/BT (time A), at the last day of EBRT (70.2-72.0 Gy) or one month after BT (time B), and a median time of 16 months after EBRT/BT (time C) using a validated questionnaire (Expanded Prostate Cancer Index Composite). Pairs were matched according to the following criteria: age +/-5 years, prostate volume +/-10 cc, use of antiandrogens, and erectile function. RESULTS: Urinary function/bother scores decreased significantly more after BT both at time B and time C. Bowel function/bother scores tended to be higher after BT, with a lower percentage of patients with painful bowel movements (BT: 12%/27%/15%; EBRT: 19%/52%/35% at time A/B/C; p<0.05 for differences at times B/C) and rectal bleeding (BT: 12%/12%/12%; EBRT: 8%/14%/17%). No difference concerning erectile dysfunction was found (67% vs. 61% with preserved erections firm enough for intercourse after BT vs. EBRT at time C). CONCLUSIONS: BT was associated with higher urinary, but lower rectal toxicity. The risk of treatment-associated erectile dysfunction did not differ between these methods.

Seed displacements after permanent brachytherapy for prostate cancer in dependence on the prostate level.

PURPOSE: To evaluate seed displacements after permanent prostate brachytherapy considering different prostate levels. PATIENTS AND METHODS: In 61 patients, postimplant CT scans were performed 1 day and 1 month after an implant with stranded seeds. Seed and prostate surface displacements were determined relative to pelvic bones. Four groups of seed locations were selected: seeds at the base (n = 305; B), at the apex (n = 305; A), close to the urethra (n = 306; U), and close to the rectal wall (n = 204; R). The length of two strands (always containing four seeds) per patient was measured in all CT scans and compared. RESULTS: The largest inferior seed displacements were found at the base: mean 5.3 mm (B), 2.2 mm (A), 2.7 mm (U), 3.3 mm (R; p < 0.001). Posterior displacements predominated both at the base and the central region: mean 2.2 mm (B), 2.0 mm (U), 0.8 mm (A), -0.6 mm (R; p < 0.001). With a decreasing edema between day 1 and 30 (mean prostate volume of 51 cm(3) vs. 41 cm(3); p < 0.001), a mean caudal prostate base displacement of 3.9 mm was found, whereas the mean inward displacement ranged from 1.2 to 1.6 mm at the remaining borders (lateral, anterior, posterior, apical). The analysis of the strand lengths revealed an implant compression between day 1 and 30 (mean 1.7 mm; p < 0.001). CONCLUSION: The largest prostate tissue and seed displacements were observed at the prostate base, associated with an implant compression. Predominantly inferior and posterior displacements implicate consequential smaller preplanning margins at the apex and the posterior prostate.

Evaluation of source displacement and dose--volume changes after permanent prostate brachytherapy with stranded seeds.

BACKGROUND AND PURPOSE: The aim of the study was to analyze source displacements and dose-volume changes in the first month after a permanent implant. MATERIALS AND METHODS: In 51 consecutive patients, CT scans were performed at the postoperative day (day 1) and one month (day 30) after an (125)I implant with stranded seeds. Seed positions were determined relative to pelvic bones for five seeds at the base and five seeds at the apex for each patient (n=510) and compared. To verify these results, treatment margins (TM=distance of prescription isodose to prostate) and displacements of the prostate surface (anterior/posterior/right/left/superior/inferior) relative to pelvic bones were measured. RESULTS: Seed positions have moved significantly between day 1 and 30 in the posterior (mean 1.0mm; p<0.001) and inferior (mean 3.8mm; p<0.001) directions. TM increased particularly at the posterior (mean 2.2mm; p<0.001) and apical (median 3.0mm; p<0.001) prostate contour with decreasing oedema. With a stable apex position and a mean inward posterior surface displacement of 1.1mm (p<0.001) relative to pelvic bones, seed displacements could be well correlated with prescription isodose displacements (Pearson correlation coefficients >or=0.81; p<0.001). CONCLUSIONS: Both changes of prostate volume and seed displacements need to be considered to explain dosimetric changes after permanent prostate brachytherapy.

Prostate-specific antigen kinetics after brachytherapy or external beam radiotherapy and neoadjuvant hormonal therapy.

OBJECTIVES: To characterize the kinetics of prostate-specific antigen (PSA) after radiotherapy (RT) and neoadjuvant hormonal therapy (NHT) for localized prostate cancer. METHODS: The PSA kinetics of 75 consecutive patients who had undergone RT and NHT (median time 4 months) were followed up for a minimum of 24 months after treatment. RT included a permanent iodine-125 implant (n = 29), a temporary iridium-192 implant as a boost to external beam RT (n = 21), and sole external beam RT (n = 25). A median number of 11 PSA levels per patient were analyzed. RESULTS: After a first nadir (median level 0.1 ng/mL 3 months after RT), rising PSA levels were found in 83% of patients and progressively rising PSA levels until the end of follow-up or salvage hormonal therapy for 21% of patients. The PSA levels dropped again after one (23%), two (21%), or more (17%) consecutive increases up to a median level of 0.6 ng/mL (median time 16 months after RT), so that a nadir of 0.1 ng/mL was reached for a second time (median time 35 months after RT). A first nadir of less than 0.1 ng/mL, a PSA increase of less than 1 ng/mL, and a longer PSA doubling time (median time 10 months) were strongly predictive for long-term biochemical control. CONCLUSIONS: Temporarily rising PSA levels can be expected for most patients after primary RT and NHT following a first nadir. The increasing effects of testosterone owing to NHT withdrawal have a stronger effect than RT in the first months after treatment.

Health-related quality of life after permanent interstitial brachytherapy for prostate cancer: correlation with postimplant CT scan parameters.

PURPOSE: To determine dosimetric risk factors for increased toxicity after permanent interstitial brachytherapy for prostate cancer. PATIENTS AND METHODS: Quality of life questionnaires (Expanded Prostate Cancer Index Composite) of 60 and 56 patients were analyzed after a median posttreatment time of 6 weeks (A-acute) and 16 months (L-late). The corresponding CT scans were performed 30 days after the implant. The prostate, rectal wall, and base of seminal vesicles were contoured. Prostate volume, number of seeds and needles as well as dosimetric parameters were correlated with the morbidity scores. RESULTS: For a prostate volume of 38 +/- 12 cm(3) (mean +/- standard deviation), 54 +/- 7 (125)I sources (Rapid Strands), activity of 22.6 +/- 3.0 MBq [0.61 +/- 0.08 mCi]) were implanted using 20 +/- 6 needles. Improved late urinary function scores resulted from a higher number of sources per cm(3) (> or = 1.35). A prostate D(90) < 170 Gy (A)/< 185 Gy (L) and base of seminal vesicle D(10) < 190 Gy (A and L) were associated with higher urinary function scores. Late rectal function scores were significantly higher for patients with a prostate V(200) < 50% and V(150) < 75%. Patients with a prostate volume < 40 cm(3) reached better sexual function scores (A and L). A higher number of needles per cm(3) (> or = 0.5) resulted in improved late urinary, bowel and sexual function scores. CONCLUSION: Quality of life after a permanent implant can be improved by using an adequate amount of sources and needles. With an increasing number of seeds per cm(3), dose homogeneity is improving. A prostate D(90) < 170 Gy and a base of seminal vesicle D(10) < 190 Gy (as an indicator of the dose to the bladder neck and urethral sphincter) can be recommended to maintain a satisfactory urinary function.

Changes of dose delivery distribution within the first month after permanent interstitial brachytherapy for prostate cancer.

PURPOSE: To evaluate changes of dose distribution for both the prostate and the surrounding tissues after permanent brachytherapy as monotherapy for prostate cancer. PATIENTS AND METHODS: In 35 patients, CT scans were performed before, 1 day after (day 1) and 1 month after the implantation (day 30). Changes of prostate volume, dosimetric parameters, and distances between posterior prostate contour and rectal wall as well as prostate contour and prescription isodose were analyzed. RESULTS: Prostate volume increased from 37+/-11 cm3 (mean+/-standard deviation) to 49+/-12 cm3 on day 1 and dropped to 40+/-9 cm3 on day 30. Prostate V100 increased from 87+/-7% to 90+/-7%, prostate D90 from 138+/-21 Gy to 151+/-30 Gy. Mean rectal volume covered by the prescription isodose rose from 0.4 cm3 to 1.0 cm3; a changing distance between the prostate and rectal wall was excluded as a reason. Prostate D90 (day 1) and rectum V100 (day 30) proved to be significantly higher for larger prostate sizes. The distance between the prescription isodose and the prostate contour increased particularly at the posterior and inferior borders: 1.9 mm and 2.5 mm on average (0.1 mm and -0.7 mm at opposite borders, respectively). CONCLUSION: With a decreasing edema of the prostate, an increasing dose both to the prostate and the anterior rectal wall resulted--the postimplant interval is essential for the dosimetry report. Due to a larger edema, a higher prescription dose might be needed for optimal cancer control in smaller prostates. Compared to day 1, the dose to the surrounding tissues increased on day 30, particularly at the posterior and inferior prostate borders.

Association of neoadjuvant hormonal therapy with adverse health-related quality of life after permanent iodine-125 brachytherapy for localized prostate cancer.

OBJECTIVES: To characterize the influence of neoadjuvant hormonal therapy (NHT) on health-related quality of life after permanent iodine-125 brachytherapy (BT) for prostate cancer. METHODS: A cross-sectional survey using the Expanded Prostate Cancer Index Composite health-related quality-of-life instrument was administered to 134 consecutive patients a median of 29 months after BT. A separate group of 111 patients with comparable demographic characteristics without any prior treatment for prostate cancer rendered the baseline information (control group). The scores and symptom rates were compared. The effect of NHT was tested for independence in a multivariate analysis. RESULTS: In contrast to patients who received NHT, prostatic edema was hardly detectable 30 days after implantation in patients who received BT alone (comparing median preimplant and postimplant volumes), resulting in a greater dose to the prostate and anterior rectal wall. However, compared with the control group and the patients who received BT alone, the addition of NHT to BT led to lower health-related quality-of-life scores in all domains. Score differences of more than 10 points with a statistical significance were found for the urinary bother, sexual function/bother, and hormonal function/bother domains. Apart from the sexual function scores (patient age shown to be the crucial factor), the influence of NHT remained independent on multivariate analysis. CONCLUSIONS: The results stress the need for well-considered administration of NHT before BT and the need for reporting the use of NHT in studies dealing with BT-related toxicity.

Erectile function after non-nerve-sparing radical prostatectomy: fact or fiction?

OBJECTIVE: To evaluate the potency in patients after radical perineal prostatectomy with wide excision of both neurovascular bundles. MATERIAL AND METHODS: In this prospective study, a quality-of-life questionnaire was completed by 128 patients at the preoperative stage, and 6 and 12 months postoperatively. Ten questions concerning the patient's sexuality were included on the pre- and both postoperative questionnaires. In addition, 6 patients who recorded some erectile function were sent a separate questionnaire containing eight more detailed questions. RESULTS: Preoperatively, 74/128 (57.8%) patients reported erections sufficient for sexual intercourse, and of these 74, 6 (8.1%) described having spontaneous erections 1 year postoperatively. These spontaneous erections occurred 1-5 times per week. The reply to the separate mailing made clear that the reported erections were insufficient for intercourse. CONCLUSIONS: Patients undergoing standardized radical prostatectomy with wide excision of the neurovascular bundle have a very small chance of spontaneous erections sufficient for intercourse postoperatively.

Dose-volume impact in high-dose-rate Iridium-192 brachytherapy as a boost to external beam radiotherapy for localized prostate cancer--a phase II study.

BACKGROUND AND PURPOSE: Evaluation of dose-volume-time-related factors in 64 patients treated with high-dose-rate brachytherapy (HDR-BT) as a boost to external beam radiotherapy (EBRT) for localized prostate cancer. PATIENTS AND METHODS: Clinical parameters were correlated with morbidity scores of the EPIC (Expanded Prostate Cancer Index) questionnaire. Median time after radiotherapy (HDR-BT up to 18 Gy in two fractions and EBRT up to a median dose of 50.4 Gy) was 1.5 and 3 years (first and second questionnaire). RESULTS: A significant impact of a urethra D1 exceeding 15 Gy in at least one HDR fraction concerning urinary morbidity and a rectum D1 exceeding 6 Gy to the rectal mucosa in the first and second HDR fraction concerning the rectal bleeding rate was found. A higher number of needles was associated with lower urinary and bowel scores after 1.5 years. A prostate length >4.8 cm and a longer duration of EBRT (independently of the dose) predisposed for lower urinary and bowel scores. In contrast to a urethra D1 > 15 Gy as an independent factor, a rectum D1 > 6 Gy per HDR fraction correlated with a higher number of needles and an increased prostate length. CONCLUSIONS: To minimize morbidity in HDR-BT for prostate cancer, a maximum dose to the urethra of 15 Gy and a maximum dose to the rectal mucosa of 6 Gy is advisable. Treatment- and patient-related factors have a major impact on toxicity.

Fecal incontinence after radical perineal prostatectomy: a prospective study.

OBJECTIVES: To assess, in a prospective study, the incidence of fecal incontinence after radical perineal prostatectomy. METHODS: Bowel symptoms were evaluated with questionnaires mailed to 132 patients preoperatively and 6 months postoperatively, and annually thereafter. All patients had undergone extrafascial perineal prostatectomy for Stage cT1-cT3N0M0 prostate cancer. The data of 116 patients (88%), who answered at least the preoperative and 12-month questionnaires, were analyzed. Reduced sensibility, reduced discrimination, urgency, or stool smearing were symptoms indicative of fecal incontinence. Patients with one symptom of fecal incontinence were evaluated further with a structured telephone interview. RESULTS: Daily stool smearing was reported preoperatively by 4% of the patients. Two symptoms related to fecal incontinence were present preoperatively in 6% of the patients. At 12 months postoperatively, 15 patients (13%) reported at least two symptoms of fecal incontinence. The structured telephone interview revealed that 6 of these 15 patients had symptoms of fecal incontinence that were related to the perineal prostatectomy; 9 patients had newly developed symptoms not related to surgery or symptoms due to tumor recurrence or radiotherapy. Patients with the presence of at least one symptom of fecal incontinence before surgery had an almost fourfold increased risk of developing at least two symptoms of fecal incontinence postoperatively compared with patients without any symptom of fecal incontinence. CONCLUSIONS: Significant fecal incontinence after radical extrafascial perineal prostatectomy is a rare event. The results of questionnaires should be supplemented by additional interviews to obviate wrong interpretations.

Permanent 125I-seed brachytherapy or radical prostatectomy: a prospective comparison considering oncological and quality of life results.

OBJECTIVE: To assess the quality of life in patients with prostate cancer after permanent brachytherapy (BT) or radical perineal prostatectomy (RP). PATIENTS AND METHODS: The American Brachytherapy Society recommends the permanent implantation of radioactive seeds as a monotherapy for patients with T1-T2aN0M0 prostate cancer and a prostate-specific antigen (PSA) level of < or = 10 ng/mL, a Gleason score of <7 and a prostate volume of <60 mL. Using these criteria, 132 patients with low-risk prostate cancer were selected; 52 had BT with 125I-seed implantation, 38 had RP with unilateral nerve-sparing (RP + NS) and 42 extended RP (RP group). Only patients with unilateral tumour on biopsy were considered. Before therapy and 6, 12 and 24 months afterward, patients completed questionnaires to assess perceived health and function. PSA relapse was diagnosed with a PSA of >0.1 ng/mL for patients in the RP groups, and three consecutive PSA increases for those after BT. RESULTS: Extraprostatic tumours were found in 18% of specimens taken during RP, and bilateral tumours in 63% of patients. After a mean follow-up of 27 months, there was PSA relapse in two of the 80 patients in the RP and RP + NS groups, and six of the 52 patients in the BT group; a significant difference, with a hazard ratio of 5.2. The acute morbidity was low in all groups. At 1 year, more than two incontinence pads were used by 5% of patients after RP and by 4% after BT. Similarly, at 1 year 15% of patients after RP and 13% after BT were bothered by urinary incontinence. Newly-developed fecal soiling was reported by 4%, 5% and 11% of the RP, RP + NS and BT groups respectively; none of the patients after RP and 4% after BT were bothered by this symptom. The duration and stiffness of erection was assessed after 1 year and reported to be equal or slightly decreased by a third after RP + NS and 38% after BT. Taking a 5-10 point difference as clinically relevant, role, emotional and social functioning were improved considerably after RP + NS than after BT, but sexual activity was impaired significantly after RP + NS than after BT. CONCLUSIONS: Both therapies showed typical acute and late morbidity; the most bothersome late symptoms were urinary incontinence for patients after RP and fecal soiling after BT. Sexual function was impaired significantly in patients who were potent before RP + NS, whereas after BT men reported only a minor change in sexual performance at 1 year. Tumour control after a median follow-up of 27 months was better after RP but biochemical recurrence may still occur after > or = 5 years; therefore the present results are not mature enough and there were too few patients to provide a more definitive statement. As approximately 18% of patients considered to be appropriate candidates for BT had tumours extending beyond the prostate capsule or invading the seminal vesicles, nomograms are needed for more accurate information before therapy.

Numeric definition of the clinical performance of the nested reverse transcription-PCR for detection of hematogenous epithelial cells and correction for specific mRNA of non-target cell origin as evaluated for prostate cancer cells.

BACKGROUND: Inappropriate quality management of reverse transcription-PCR (RT-PCR) assays for the detection of blood-borne prostate cancer (PCa) cells hampers clinical conclusions. Improvement of the RT-PCR methodology for prostate-specific antigen (PSA) mRNA should focus on an appropriate numeric definition of the performance of the assay and correction for PSA mRNA that is not associated with PCa cells. METHODS AND RESULTS: Repeated (RT-)PCR tests for PSA mRNA in single blood specimens from PCa patients and PCa-free controls, performed by four international institutions, showed a large percentage (approximately equal to 50%) of divergent test results. The best estimates of the mean, lambda (SD), of the expected Poisson frequency distributions of the number of positive tests among five replicate assays of samples from PCa-free individuals were 1.0 (0.2) for 2 x 35 PCR cycles and 0.2 (0.1) for 2 x 25 PCR cycles. Assessment of the numeric value of the mean can be considered as a new indicator of the performance of a RT-PCR assay for PSA mRNA under clinical conditions. Moreover, it determines the required number of positive test repetitions to differentiate between true and false positives for circulating prostate cells. At a predefined diagnostic specificity of > or = 98%, repeated PCRs with lambda of either 1.0 or 0.2 require, respectively, more than three or more than one positive tests to support the conclusion that PSA mRNA-containing cells are present. CONCLUSIONS: Repeated nested PCR tests for PSA and appropriate handling of the data allow numeric quantification of the performance of the assay and differentiation between analytical false and true positives at a predefined accuracy. This new approach may contribute to introduction of PSA RT-PCR assays in clinical practice.