Abstract Background In spite of the increasing use of robot-assisted radical prostatectomy (RALP) worldwide, no level 1 evidence-based benefit favouring RALP versus pure laparoscopic approaches has ...been demonstrated in extraperitoneal laparoscopic procedures. Objective To compare the operative, functional, and oncologic outcomes between pure laparoscopic radical prostatectomy (LRP) and RALP. Design, setting, and participants From 2001 to 2011, 2386 extraperitoneal LRPs were performed consecutively in cases of localised prostate cancers. Intervention A total of 1377 LRPs and 1009 RALPs were performed using an extraperitoneal approach. Outcome measurements and statistical analysis Patient demographics, surgical parameters, pathologic features, and functional outcomes were collected into a prospective database and compared between LRP and RALP. Biochemical recurrence–free survival was tested using the Kaplan-Meier method. Mean follow-up was 39 and 15.4 mo in the LRP and RALP groups, respectively. Results and limitations Shorter durations of operative time and of hospital stay were reported in the RALP group compared with the LRP group ( p < 0.001) even beyond the 100 first cases. Mean blood loss was significantly lower in the RALP group ( p < 0.001). The overall rate and the severity of the complications did not differ between the two groups. In pT2 disease, lower rates of positive margins were reported in the RALP group ( p = 0.030; odds ratio OR: 0.396) in multivariable analyses. The surgical approach did not affect the continence recovery. Robot assistance was independently predictive for potency recovery ( p = 0.045; OR: 5.9). Survival analyses showed an equal oncologic control between the two groups. Limitations were the lack of randomisation and the short-term follow-up. Conclusions Robotic assistance using an extraperitoneal approach offers better results than pure laparoscopy in terms of operative time, blood loss, and hospital stay. The robotic approach independently improves the potency recovery but not the continence recovery. When strict indications of nerve-sparing techniques are respected, RALP gives better results than LRP in terms of surgical margins in pathologically organ-confined disease. Longer follow-up is justified to reach conclusions on oncologic outcomes.
What's known on the subject? and What does the study add?
Even after a negative set of prostate biopsies, the risk of undetected prostate cancer remains clinically significant. Predictive markers of ...such a risk are undefined.
In addition to PSA and PSAD, low prostate volume and %fPSA are interesting time‐varying risk factors and are relevant in biopsy decision‐making.
Objective
To assess prospectively the time‐varying risk of rebiopsy and of prostate cancer (PCa) detection after an initial negative biopsy protocol.
Patients and Methods
Over a period of 10 years, 1995 consecutive patients with initially negative biopsies were followed.
Rebiopsies were performed in patients who had a persistent suspicion of PCa.
Predictive factors for rebiopsy and for PCa detection were tested using univariate, multivariate and time‐dependent models.
Results
A total of 617 men (31%) underwent at least one rebiopsy after a mean follow‐up of 19 months.
PCa detection rates during second, third, and fourth sets of biopsies were 16.7, 16.9 and 12.5%, respectively. The overall rate of detected PCa was 7.0%.
The 5‐year rebiopsy‐free and PCa‐free survival rates were 65.9 and 92.5%, respectively.
Indications for rebiopsy were more frequently reported in patients having a high prostate‐specific antigen (PSA) level (P = 0.006) or a high PSA density (PSAD; P < 0.001) and in younger patients (P = 0.008). The risk of PCa on rebiopsies was not correlated with age, but significantly increased more than twofold in cases of PSA >6 ng/mL, PSAD >0.15 ng/mL/g, free‐to‐total PSA ratio (%fPSA) <15, and/or prostate volume <50 mL. Time‐dependent analyses were in line with these findings.
The main study limitation was the lack of control of the absence of PCa and PSA kinetics in men not rebiopsied.
Conclusions
The overall risk of detected PCa after an initial negative biopsy was low.
In addition to PSA and PSAD, which are well‐used in rebiopsy indications, low prostate volume and %fPSA are interesting time‐varying risk factors for PCa on rebiopsy and could be relevant in biopsy decision‐making.
Study Type – Therapy (case series) Level of Evidence 4
What’s known on the subject? and What does
the study add?
Despite excellent surgical cancer control, up to 40% of patients will have biochemical ...recurrence following radical prostatectomy (RP) for localized prostate cancer. Positive surgical margins (PSM) have been clearly demonstrated to be one of the main predictive factors for biochemical failure, disease progression and cancer mortality. However, decision of further management (adjuvant or salvage therapy) in patients with PSM remains controversial, and many debatable questions arise concerning the incidence of clinical progression and the impact of systematic adjuvant treatment on the cancer specific and overall survival.
Analysis of the pathological and disease recurrence outcomes of our large cohort of patients treated by RP provides evidence that PSMs are associated with a poor prognosis in terms of PSA failure and need for salvage therapy. However, such a distinction between negative or positive margin cancers seems to appear clinically less relevant in locally advanced disease with seminal vesicle or high Gleason score ≥ 8 due to the predominant significance of these two poor prognosis factors for prediction of PSA failure.
OBJECTIVE
• To study the impact of positive surgical margins (PSMs) as an independent predictor of prostate‐specific antigen (PSA) failure after radical prostatectomy in adjuvant treatment‐naïve patients.
PATIENTS AND METHODS
• From 2000 to 2008, 1943 men who underwent a radical prostatectomy at Henri Mondor Hospital and who did not receive neoadjuvant or adjuvant therapy were included. Follow‐up was recorded into a prospective database. Mean follow‐up was 68.8 months.
• The biochemical recurrence‐free survival (RFS), defined by a PSA > 0.2 ng/mL, and the need for salvage therapy in univariate and multivariate models, were evaluated.
RESULTS
• PSA failure was reported in 14.7% and PSMs were noted in 25.6%. In the overall cohort, PSM was significantly predictive for PSA failure (P < 0.001; hazard ratio, HR, 2.6), need for salvage therapy (P < 0.001; HR, 2.9) and specific deaths (P= 0.006; HR, 3.7). The 5‐year RFS was 84.4% in men with negative margins compared to 57.5% in the case of PSM.
• After stratification by pathological stage and Gleason score, margin status was significantly predictive for PSA failure in pT2 (P < 0.001), pT3a (P= 0.001) and/or Gleason score ≤7 cancers (P < 0.001), whereas the impact of PSM did not reach significance in pT3b (P= 0.196), pT4 (P= 0.061) and/or Gleason score ≥8 cancers (P= 0.115).
CONCLUSIONS
• PSMs are associated with a poor prognosis in terms of RFS and the need for salvage therapy.
• Such a distinction between negative or positive margin cancers appears to be clinically less relevant in locally advanced disease with seminal vesicle or high Gleason score (≥8).
Purpose
To evaluate the safety and efficacy of retroperitoneal laparoscopic resection in patients with pheochromocytoma in a retrospective study.
Methods
Clinical data of patients with adrenal and ...extra-adrenal pheochromocytomas, operated on between September 1998 and September 2008 at two institutions, including information on patient demographics, surgical procedure, complications and hospital stay were retrieved.
Results
Seventy-two retroperitoneal laparoscopic resections were performed (68 patients, 30 males/38 females). Mean age was 51.4 years (15–87 years). Four patients had a bilateral pheochromocytoma. Median BMI was 27 kg/m
2
(interquartile range 23–29). Mean tumour diameter was 4.6 cm (1.3–9). Thirteen patients had a tumour >6 cm. Mean operation time was 110 min (40–210), and median blood loss during surgery was 160 ml (0–1200 ml). Duration of surgery significantly increased with BMI (
p
= 0.004) and tumour size (
p
= 0.004). Four patients required conversion to open surgery (two bleeding, one severe adhesion to inferior vena cava and one renal artery aneurysm). Five patients required a blood transfusion with minor postoperative complications in three patients. Major perioperative haemodynamic variations (systolic blood pressure > 180 mmHg, diastolic blood pressure < 70 mmHg) were observed in 54 % of patients, 30 % required postoperative adrenergic drug treatment. The only predictive factor of a perioperative haemodynamic complication was the high level of normetanephrine in the preoperative blood samples. The median postoperative hospital stay was 4.5 days. Blood loss, postoperative complication and postoperative hospital stay did not increase in patients with tumours >6 cm.
Conclusion
Retroperitoneal laparoscopic surgery for pheochromocytoma is reproducible, safe and effective.
Purpose Robotics in surgery is a recent innovation. This technology offers a number of attractive features in laparoscopy. It overcomes the difficulties with fixed port sites by restoring all 6 ...degrees of freedom at the instrument tips, provides new possibilities for miniaturization of surgical tasks and allows remote controlled surgery. We investigated the applicability of remote controlled robotic surgery to laparoscopic radical prostatectomy. Materials and Methods Our previous experience with laparoscopic prostatectomy served as a basis for adapting robotic surgery to this procedure. A surgeon at a different location who activated the tele-manipulators of the da Vinci robotic system performed all steps of the intervention. A scrub nurse and second surgeon who stood at patient side had limited roles to port and instrument placement, exposure of the operative field, assistance in hemostasis and removal of the operative specimen. Our patient was a 63-year-old man presenting with a T1c tumor discovered on 1 positive sextant biopsy with a 3+3 Gleason score and 7 ng./ml. preoperative serum prostate specific antigen. Results The robot provided an ergonomic surgical environment and remarkable dexterity enhancement. Operating time was 420 minutes, and the hospital stay lasted 4 days. The bladder catheter was removed 3 days postoperatively, and 1 week later the patient was fully continent. Pathological examination showed a pT3a tumor with negative margins. Conclusions Robotically assisted laparoscopic radical prostatectomy is feasible. This new technology enhances surgical dexterity. Further developments in this field may have new applications in laparoscopic tele-surgery.
Purpose We compared the pathological findings and prostate specific antigen outcome after radical prostatectomy in men eligible for active surveillance according to 3 biopsy inclusion criteria. ...Materials and Methods The study population included 177 men eligible for active surveillance who fulfilled clinicobiological criteria and biopsy criteria as group 1—less than 3 positive cores and less than 3 mm total tumor length, group 2—less than 3 positive cores with cancer involvement of less than 50% in any core and group 3—less than 33% of positive cores. Prostate specific antigen density cutoffs were also studied in these groups. Pathological findings on radical prostatectomy specimens and biochemical recurrence-free survival were studied. Median followup after radical prostatectomy was 34 months. Results A majority of Gleason score 6 disease was observed in group 1 (51.7%) whereas a majority of Gleason score 7 or greater disease was reported in groups 2 (53.6%) and 3 (55.4%). Extracapsular extension was noted in 17.5% of radical prostatectomy specimens in group 3 vs 11.2% in group 1 (p = 0.175). The risk of overall unfavorable disease (defined as pT3–4 stage and/or Gleason score 8 or greater) was significantly higher in men with cancer involvement of 3 mm or greater on initial biopsy (27.3% vs 13.5%, respectively, p = 0.023). The 3-year biochemical recurrence-free survival rate was 94.0% and was not affected by the 3 active surveillance definitions. Conclusions Even with the use of a 21-core biopsy protocol the rate of unfavorable disease in radical prostatectomy specimens remains increased in men eligible for active surveillance. Patients must be informed of this risk of misclassification which ranges from 20% to 28% in men who fulfill the less stringent biopsy criteria.
What's known on the subject? and What does the study add?
Several criteria have been described to select patients with prostate cancer in active surveillance (AS) protocols; however, the risk of ...missing unfavourable disease remains.
We report the risk of misclassification using the Prostate Cancer Research International: Active Surveillance (PRIAS) study in an analysis of pathological results after radical prostatectomy. We also define predictors of favourable disease that can be used to better select patients eligible for AS, as well as risk factors associated with disease progression.
Objective
To identify the risk of failure of active surveillance (AS) in men who had the Prostate Cancer Research International: Active Surveillance (PRIAS) criteria and had undergone radical prostatectomy (RP), by studying as primary endpoints the risk of unfavourable disease in RP specimens (stage >T2 and/or Gleason score >6) and of biochemical progression after RP.
Patients and Methods
We assessed 626 patients who had the PRIAS criteria for AS defined as T1c/T2, PSA level of ≤10 ng/mL, PSA density (PSAD) of <0.2 ng/mL per mL, Gleason score of <7, and one or two positive biopsies. All patients underwent immediate RP at our department between January 1991 and December 2010.
Multivariate logistic regression was used to test factors correlated with the risk of unfavourable prostate cancer.
The risk of progression was tested using multivariate Cox regression models.
Biochemical recurrence‐free survival (BFS) was established using the Kaplan–Meier method
Results
Pathological study of RP specimens showed upstaging (>T2) in 129 patients (20.6%), upgrading (Gleason score >6) in 281 (44.9%) and unfavourable disease in 312 patients (50%).
There was a statistically non‐significant trend for BFS at P = 0.06.
Predictors of favourable tumours were age <65 years (P = 0.005), one vs two positive biopsies (P = 0.01) and a biopsy core number >12 (P = 0.005).
Preoperative factors predicting disease progression were a PSAD of >0.15 ng/mL2 (P = 0.008) and biopsy core number of ≤12 (P = 0.017).
Conclusions
Even with stringent AS criteria, the rate of unfavourable disease remains high.
Predictive factors of unfavourable disease and biochemical progression should be considered when including patients in AS protocols.
Study Type – Diagnostic (case series)
Level of Evidence 4
OBJECTIVE
•
To investigate the role of magnetic resonance imaging (MRI) in selecting patients for active surveillance (AS).
PATIENTS AND ...METHODS
•
We identified prostate cancers patients who had undergone a 21‐core biopsy scheme and fulfilled the criteria as follows: prostate‐specific antigen (PSA) level ≤10 ng/mL, T1–T2a disease, a Gleason score ≤6, <3 positive cores and tumour length per core <3 mm.
•
We included 96 patients who underwent a radical prostatectomy (RP) and a prostate MRI before surgery.
•
The main end point of the study was the unfavourable disease features at RP, with or without the use of MRI as AS inclusion criterion.
RESULTS
•
Mean age and mean PSA were 62.4 years and 6.1 ng/mL, respectively. Prostate cancer was staged pT3 in 17.7% of cases.
•
The rate of unfavourable disease (pT3–4 and/or Gleason score ≥4 + 3) was 24.0%. A T3 disease on MRI was noted in 28 men (29.2%).
•
MRI was not a significant predictor of pT3 disease in RP specimens (P = 0.980), rate of unfavourable disease (P = 0.604), positive surgical margins (P = 0.750) or Gleason upgrading (P = 0.314).
•
In a logistic regression model, no preoperative parameter was an independent predictor of unfavourable disease in the RP specimen.
•
After a mean follow‐up of 29 months, the recurrence‐free survival (RFS) was statistically equivalent between men with T3 on MRI and those with T1–T2 disease (P = 0.853).
CONCLUSION
•
The results of the present study emphasize that, when the selection of patients for AS is based on an extended 21‐core biopsy scheme, and uses the most stringent inclusion criteria, MRI does not improve the prediction of high‐risk and/or non organ‐confined disease in a RP specimen.
Abstract Background The debate on the optimal number of prostate biopsy core samples that should be taken as an initial strategy is open. Objective To prospectively evaluate the diagnostic yield of a ...21-core biopsy protocol as an initial strategy for prostate cancer (PCa) detection. Design, setting, and participants During 10 yr, 2753 consecutive patients underwent a 21-core biopsy scheme for their first set of biopsy specimens. Intervention All patients underwent a standardized 21-core protocol with cores mapped for location. Outcome measurements and statistical analysis The PCa detection rate of each biopsy scheme (6, 12, or 21 cores) was compared using a McNemar test. Predictive factors of the diagnostic yield achieved by a 21-core scheme were studied using logistic regression analyses. Results and limitations PCa detection rates using 6 sextant biopsies, 12 cores, and 21 cores were 32.5%, 40.4%, and 43.3%, respectively. The 12-core procedure improved the cancer detection rate by 19.4% ( p = 0.004), and the 21-biopsy scheme improved the rate by 6.7% overall ( p < 0.001). The six far lateral cores were the most efficient in terms of detection rate. The diagnostic yield of the 21-core protocol was >10% in prostates with volume >70 ml, in men with a prostate-specific antigen level < 4 ng/ml, with a prostate-specific antigen density (PSAD) <0.20 ng/ml per gram. A PSAD <0.20 ng/ml per gram was the strongest independent predictive factor of the diagnostic yield offered by the 21-core scheme ( p < 0.001). The 21-core protocol significantly increased the rate of PCa eligible for active surveillance (62.5% vs 48.4%; p = 0.036) than those detected by a 12-core scheme without statistically increasing the rate of insignificant PCa ( p = 0.503). Conclusions A 21-core biopsy scheme improves significantly the PCa detection rate compared with a 12-core protocol. We identified a cut-off PSAD (0.20 ng/ml per gram) below which an extended 21-core scheme might be systematically proposed to significantly improve the overall detection rate without increasing the rate of detected insignificant PCa.
Purpose
To study the prognostic value of extent, number, and location of positive surgical margins (PSM).
Methods
A total of 1,504 consecutive adjuvant treatment naive and node-negative radical ...prostatectomy men were included in a prospective database including extent, number, and location of PSM. Mean follow-up was 33 months. Endpoint was biochemical progression-free (bPFS) survival. The impact of margin status and characteristics was assessed in time-dependent analyses using Cox regression and Kaplan–Meier methods.
Results
PSM was reported in 26.7 % of patients. The predominant PSM locations were apex and posterior locations. Median PSM length was 4.0 mm. The 2-year bPFS was 73.7 % in PSM patients as compared to 93.0 % in NSM patients (
p
< 0.001). The rate and extent of PSM increased significantly with pathologic stage (
p
< 0.001). The extent of PSM length was linearly correlated with bPFS (
p
= 0.017, coefficient: −0.122). In univariable analysis, extent and number of PSM were significantly linked to outcomes. None of PSM subclassifications significantly influenced the bPFS rates in the subgroup of pT2 disease patients. Conversely, stratification by PSM location (apex vs. other locations,
p
= 0.008), by PSM number (
p
= 0.006), and by PSM length (
p
< 0.001) showed significant differences in pT3-4 cancer patients. In that subgroup, PSM length also added to bPFS prediction using PSM status only in multivariable models (
p
= 0.005).
Conclusions
PSM subclassifications do not improve the biochemical recurrence prediction in organ-confined disease. In non-organ-confined disease, PSM length (≥3 mm), multifocality (≥3 sites), and apical location are significantly linked to poorer outcomes and could justify a more aggressive adjuvant treatment approach.
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