Variations in procedure time based on surgery resident postgraduate year level.

BACKGROUND: With increasing scrutiny being placed on the allocation of health care dollars, data supporting the increased resources used to teach residents in the operating room (OR) are lacking. METHODS: All cases of patients undergoing laparoscopic cholecystectomies (LCs) and pancreaticoduodenectomies (PDs) from July 1, 2006 to July 1, 2011 were analyzed. Procedures were excluded based on the following: more than one resident listed in the operative report, with the exception of interns; LC requiring cholangiogram or conversion to an open procedure; or if a PD required additional procedures. Multiple linear regression was used to evaluate the association between procedure time and postgraduate year (PGY), adjusting for patient age and estimated blood loss. RESULTS: A total of 236 PDs and 357 LCs were included in the study. For LCs, after multiple linear regression, the association between procedure time and resident PGY was marginally significant (P = 0.0519) and suggested an inverse relationship; for every increase in resident PGY, there was a 2.66-min decrease in OR time. Based on our institution's figure of $18.13/min of OR time, the cost difference between PGYs 1 and 5 performing a LC would be $192.90 per case. For PDs, however, the association between procedure time and resident PGY was not significant. CONCLUSIONS: Junior residents likely prolong procedure times for more basic procedures such as LC but not for more complex procedures such as PD.

Results of a surgically derived nomogram to predict Gleason score upgrading applied to a cohort of patients with "favorable-risk" prostate cancer treated with permanent seed brachytherapy.

OBJECTIVE: To examine a 2-year cohort of patients treated with brachytherapy to determine the likelihood of unfavorable pathologic features using a nomogram recently developed at our center to estimate the likelihood of Gleason score upgrading for patients with favorable prostate cancer undergoing radical prostatectomy. The brachytherapy outcomes for patients with a high likelihood of upgrading were compared with those with a lower likelihood to affirm the effectiveness of brachytherapy in this setting. Information on the likelihood of upgrading could help in the selection between active treatment and surveillance for patients with favorable-risk prostate cancer. METHODS: The records were examined for 259 men undergoing prostate brachytherapy in 2006 to 2007, of whom 217 had favorable risk cancer. The likelihood of Gleason score upgrading (GSU) was predicted using the radical prostatectomy-derived nomogram. RESULTS: The median age was 62 years (range 44-77), and the median prostate-specific antigen level was 4.71 ng/mL (range 0.56-9.87). Central pathology review was available for 88%, and 83% had undergone extended biopsies. Two men had received androgen deprivation therapy for prostate downsizing. The median predicted likelihood of GSU was 51.2%. The median prostate-specific antigen level for 199 patients without treatment failure after a median follow-up of 4.2 years in this cohort was 0.07 ng/mL (interquartile range undetectable to 0.23). CONCLUSION: In the present cohort of patients with favorable-risk prostate cancer treated with brachytherapy, the estimated likelihood of GSU using the surgically derived nomogram was substantial. Follow-up with prostate-specific antigen measurement has indicated that brachytherapy is a highly effective treatment option despite less favorable clinical and pathologic factors. Patients should not be discouraged from brachytherapy on the basis of a high likelihood of GSU.

Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial.

PURPOSE: The American College of Surgeons Oncology Group phase III Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial comparing radical prostatectomy (RP) and brachytherapy (BT) closed after 2 years due to poor accrual. We report health-related quality of life (HRQOL) at a mean of 5.3 years for 168 trial-eligible men who either chose or were randomly assigned to RP or BT following a multidisciplinary educational session. PATIENTS AND METHODS: After initial lack of accrual, a multidisciplinary educational session was introduced for eligible patients. In all, 263 men attended 47 sessions. Of those, 34 consented to random assignment, 62 chose RP, and 94 chose BT. Five years later, these 190 men underwent HRQOL evaluation by using the cancer-specific 50-item Expanded Prostate Cancer Index Composite, the Short Form 12 Physical Component Score, and Short Form 12 Mental Component Score. Response rate was 88.4%. The Wilcoxon rank sum test was used to compare summary scores between the two interventions. RESULTS: Of 168 survey responders, 60.7% had BT (9.5% randomly assigned) and 39.3% had RP (9.5% randomly assigned). Median age was 61.4 years for BT and 59.4 for RP (P = .05). Median follow-up was 5.2 years (range, 3.2 to 6.5 years). For BT versus RP, there was no difference in bowel or hormonal domains, but men treated with BT scored better in urinary (91.8 v 88.1; P = .02) and sexual (52.5 v 39.2; P = .001) domains, and in patient satisfaction (93.6 v 76.9; P < .001). CONCLUSION: Although treatment allocation was random in only 19%, all patients received identical information in a multidisciplinary setting before selecting RP, BT, or random assignment. HRQOL evaluated 3.2 to 6.5 years after treatment showed an advantage for BT in urinary and sexual domains and in patient satisfaction.

3D MR-spectroscopic imaging assessment of metabolic activity in the prostate during the PSA "bounce" following 125iodine brachytherapy.

PURPOSE: A temporary increase in prostate-specific antigen (PSA) values is observed in 30%-40% of men following (125)I brachytherapy (BT) for prostate cancer. We present the results of a study to characterize prostate metabolic activity during the PSA "bounce" and to correlate metabolic changes with PSA levels using three-dimensional magnetic resonance spectroscopic imaging (3D-MRSI). METHODS AND MATERIALS: 3D-MRSI was performed in 24 patients during the PSA bounce. Eight of these had also had a baseline 3D-MRSI scan before BT for the purpose of tumor mapping. The 3D-MRSI was repeated at 6- and 12-month intervals, and PSA levels were monitored every 3 months. Twenty-one of the patients had favorable-risk prostate cancer, and 3 had intermediate risk. RESULTS: The choline+creatine signal intensity, although markedly reduced, was observable following BT. Diffuse activity not corresponding to original biopsy-positive sites was observed in 22 cases, and 2 cases were documented to have local recurrence. No statistically significant correlation between metabolic activity and PSA levels at each interval was found. CONCLUSION: Post-BT prostate 3D-MRSI shows evidence of diffuse metabolic activity unrelated to residual malignancy. This supports the benign nature of the PSA bounce and suggests an inflammatory etiology. In the situation of a rising PSA, observation of focal activity on MRI/3D-MRSI could be a useful adjunct to suggest local recurrence at an earlier interval after brachytherapy when prostate biopsies would still be unhelpful. Longer follow-up is necessary to confirm the complex relationship between metabolic activity and PSA levels.

A phase III randomized trial of the timing of meloxicam with iodine-125 prostate brachytherapy.

PURPOSE: Nonsteroidal anti-inflammatory medication is used to reduce prostate edema and urinary symptoms following prostate brachytherapy. We hypothesized that a cyclooxygenase-2 (COX-2) inhibitor regimen started 1 week prior to seed implant might diminish the inflammatory response, thus reducing edema, retention rates, and symptom severity. METHODS AND MATERIALS: From March 2004 to February 2008, 316 men consented to an institutional review board-approved randomized study of a 4-week course of meloxicam, 7.5 mg orally twice per day, starting either on the day of implant or 1 week prior to implant. Brachytherapy was performed using iodine-125 seeds and was preplanned and performed under transrectal ultrasound (TRUS) and fluoroscopic guidance. Prostate volume obtained by MR imaging at 1 month was compared to baseline prostate volume obtained by TRUS planimetry and expressed as an edema factor. The trial endpoints were prostate edema at 1 month, International Prostate Symptom Score (IPSS) questionnaire results at 1 and 3 months, and any need for catheterization. RESULTS: Results for 300 men were analyzed. Median age was 61 (range, 45-79 years), and median TRUS prostate volume was 35.7 cc (range, 18.1-69.5 cc). Median IPSS at baseline was 5 (range, 0-24) and was 15 at 1 month, 16 at 3 months, and 10 at 6 months. Catheterization was required for 7% of patients (6.2% day 0 arm vs. 7.9% day -7 arm; p = 0.65). The median edema factor at 1 month was 1.02 (range, 0.73-1.7). 1.01 day 0 arm vs. 1.05 day -7 arm. Baseline prostate volume remained the primary predictor of postimplant urinary retention. CONCLUSIONS: Starting meloxicam 1 week prior to brachytherapy compared to starting immediately after the procedure did not reduce 1-month edema, improve IPSSs at 1 or 3 months, or reduce the need for catheterization.

A phase I trial of pre-operative radiotherapy for prostate cancer: clinical and translational studies.

BACKGROUND AND PURPOSE: Selected patients undergoing radical prostatectomy for localized prostate cancer can be at high-risk for pT3 disease and require subsequent radiotherapy. In a phase I trial, we investigated the feasibility of pre-operative radiotherapy for this patient subset. MATERIALS AND METHODS: Eligibility criteria were: T1/T2N0M0 tumors plus (i) Gleason >or=7, PSA>10 ng/ml and <35 ng/ml, or (ii), PSA >15 ng/ml and less <35 ng/ml (any Gleason). Patients received 25 Gy in five fractions of radiotherapy followed by radical prostatectomy. Trial endpoints included intra-operative morbidity and late toxicity following combined treatment. We also stained pre- and post-radiotherapy prostate samples for DNA damage response proteins. RESULTS: Between 2001 and 2004, 15 patients were entered on trial. Thirteen patients completed combined-modality treatment. Only one patient had signs of intra-operative inflammation. No patient had post-operative complication. There was no severe late gastrointestinal toxicity. Late genitourinary toxicity consisted of severe urinary incontinence in 2 of 13 patients. From a translational standpoint, irradiated prostate tumor tissues had long-term activation of the CDK-inhibitor p21(WAF) associated with reduced cell proliferation. CONCLUSION: Intra-operative morbidity is low following short-course, pre-operative radiotherapy. A phase II trial is planned to fully document biochemical response with this combined-modality approach.

Impact of a multi-disciplinary patient education session on accrual to a difficult clinical trial: the Toronto experience with the surgical prostatectomy versus interstitial radiation intervention trial.

PURPOSE: Random assignment to clinical trials involving different treatment modalities can be difficult. We describe our experience with the Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial (SPIRIT; ACOSOG Z0070 NCIC PR10), a randomized trial for early-stage prostate cancer comparing radical prostatectomy (RP), and brachytherapy (BT). A multidisciplinary educational session was developed to improve patient understanding of treatment options and to facilitate accrual. PATIENTS AND METHODS: Prostate cancer referrals were screened and men who met favorable risk criteria (T1c/T2a, prostate-specific antigen [PSA] < 10 ng/mL, Gleason < or = 6) were invited to a structured education session before a specialty consultation. Men and their partners viewed the SPIRIT informed-consent video and heard from a cancer patient who described his participation in a randomized trial. Then, a urologist and radiation oncologist together compared and contrasted RP and BT to establish the rationale for the trial. RESULTS: In May 2002, SPIRIT opened for accrual and was endorsed by the University Health Network urologists and radiation oncologists. The first 27 eligible patients were approached about SPIRIT, consulted both specialties, and viewed an educational video. No patients consented. The multidisciplinary education session was then introduced. Forty-seven education sessions with 263 patients resulted in 34 consents. Of 203 patients who were suitable for the study but declined random assignment, 62 chose surgery, 94 chose brachytherapy, three patients chose external radiotherapy, and 11 chose no treatment. Consent rates for eligible and suitable patients were one in six. CONCLUSION: Men who understand their treatment options and trial rationale as presented jointly by representative specialists from competing treatment modalities may be better equipped to make an informed decision and are more likely to consent to random assignment.