Six Weeks of Fluoroquinolone Antibiotic Therapy for Patients With Elevated Serum Prostate-specific Antigen Is Not Clinically Beneficial: A Randomized Controlled Clinical Trial.

OBJECTIVE: To evaluate asymptomatic men with elevated serum prostate-specific antigen (PSA) to determine whether a 6-week course of fluoroquinolone antibiotics lowers serum PSA and affects recommendations for prostate biopsy. MATERIALS AND METHODS: A randomized, single-center prospective trial of 150 men with an initial elevated PSA was conducted. Patients were randomized to 6 weeks of ciprofloxacin or observation. Those patients with persistently elevated PSA were recommended to proceed with transrectal ultrasound-guided 12-core biopsy. Those with reduced PSA were offered transrectal ultrasound-guided biopsy but could opt to continue serial digital rectal examination/PSA. Patients were followed an average of 4.6 years to assess trends in PSA and biopsy results. RESULTS: Of 136 men who completed the trial, 63 were in the treatment and 73 were in the observation group. The average PSA change from baseline was borderline statistically significant with a change of -0.68 ng/mL in the treatment arm and 0.01 ng/mL in the observation arm (P = .052). Of those who underwent biopsy, prostate cancer was diagnosed in the first biopsy in 24 (63%) of the treatment vs 27 (52%) of the observation group (P = .60) over follow-up. CONCLUSION: In a cohort of asymptomatic men with elevated PSA, there was only a borderline statistically significant change in serum PSA between patients randomized to a 6-week course of fluoroquinolones vs observation, and there was no difference in positive prostate biopsy results. Our clinical recommendation is one should not treat patients with elevated serum PSA with antibiotics in the absence of clinical symptoms of prostatitis.

Ductal prostatic adenocarcinoma: magnetic resonance imaging documenting the effect of hormone-radiotherapy.

A 74 years male with hematuria, mass on digital rectal examination, and elevated prostate specific antigen levels (26 ng/ml) underwent prostate MRI. Imaging demonstrated a prostate mass which contained multiple cystic and solid areas. Subsequent biopsy revealed ductal prostate adenocarcinoma with a Gleason grade of 5 + 4 (9). MRI suggested rectal wall invasion, which was confirmed on rectal biopsy. The patient underwent external beam radiotherapy and concomitant hormonal therapy. A follow-up MRI revealed marked response of the tumour to therapy. Based on these findings, a definitive prostatectomy and pelvic exoneration was performed, with excellent surgical result.

Comparison of intraoperatively built custom linked seeds versus loose seed gun applicator technique using real-time intraoperative planning for permanent prostate brachytherapy.

PURPOSE: To report our dosimetric results using a novel push-button seed delivery system that constructs custom links of seeds intraoperatively. METHODS AND MATERIALS: From 2005 to 2007, 43 patients underwent implantation using a gun applicator (GA), and from 2007 to 2008, 48 patients underwent implantation with a novel technique allowing creation of intraoperatively built custom links of seeds (IBCL). Specific endpoint analyses were prostate D90% (pD90%), rV100% > 1.3 cc, and overall time under anesthesia. RESULTS: Final analyses included 91 patients, 43 GA and 48 IBCL. Absolute change in pD90% (ΔpD90%) between intraoperative and postoperative plans was evaluated. Using GA method, the ΔpD90% was -8.1 Gy and -12.8 Gy for I-125 and Pd-103 implants, respectively. Similarly, the IBCL technique resulted in a ΔpD90% of -8.7 Gy and -9.8 Gy for I-125 and Pd-103 implants, respectively. No statistically significant difference in ΔpD90% was found comparing methods. The GA method had two intraoperative and 10 postoperative rV100% >1.3 cc. For IBCL, five intraoperative and eight postoperative plans had rV100% >1.3 cc. For GA, the mean time under anesthesia was 75 min and 87 min for Pd-103 and I-125 implants, respectively. For IBCL, the mean time was 86 and 98 min for Pd-103 and I-125. There was a statistical difference between the methods when comparing mean time under anesthesia. CONCLUSIONS: Dosimetrically relevant endpoints were equivalent between the two methods. Currently, time under anesthesia is longer using the IBCL technique but has decreased over time. IBCL is a straightforward brachytherapy technique that can be implemented into clinical practice as an alternative to gun applicators.

Capromab pendetide scanning has a potential role in optimizing patient selection for salvage cryosurgical ablation of the prostate.

OBJECTIVES: To evaluate an algorithm using Capromab pendetide scanning (CPS) and prostate biopsy to select appropriate patients with biochemical recurrence (BCR) after radiation therapy (RT) for salvage cryosurgical ablation of the prostate (CSAP) and to avoid premature androgen deprivation therapy (ADT); and to estimate the local salvage success rate for patients with high-risk clinical features. METHODS: Sixty-nine patients underwent a history, physical, CPS, and prostate biopsy. Patients with a negative or prostate-only positive signal and a positive biopsy were offered CSAP. Success was defined as a postsalvage nadir PSA of ≤ 0.4 ng/mL. Patients who failed were followed to establish when they required ADT. The results were compared with the putative results of applying clinical parameters alone. Patients were considered high-risk if they had any of the following characteristics: stage T3B-T4, Gleason ≥ 4 + 3, PSADT ≤ 10 months or presalvage PSA > 10 ng/mL. RESULTS: Twelve patients (6 with metastatic signal and 6 with negative biopsy) were excluded. Fifty-seven patients underwent CSAP. Overall 67% were successfully treated. Pre-salvage PSA was significantly associated with success (P = .013). Using clinical risk alone, only 14 patients achieved success compared with 38 using our algorithm. Most of the patients (75%) avoided ADT over a period of 21 months. CONCLUSIONS: Using our algorithm with CPS and prostate biopsy enabled us to spare some low-risk patients the undue morbidity of local salvage procedures that are likely to fail, while offering selected high-risk patients the opportunity for cure, avoiding premature ADT. Low presalvage PSA seems to be correlated with successful outcomes.

Laparoscopic cryoablation of renal masses: which lesions fail?

OBJECTIVE: To identify potential predictive characteristics of lesions which failed in laparoscopic renal cryoablation (LRC). We analyzed 47 lesions that underwent this approach. METHODS: We reviewed 45 consecutive patients who underwent LRC of a renal mass between 2003 and 2008 at a single institution. A total of 47 masses were identified; all were treated by 2 surgeons. We analyzed patient age, ASA, pre- and postoperative creatinine, tumor size, location, number of cryoprobes used, and histology of the lesions. We reviewed imaging to identify characteristics of those lesions which failed LRC management, defined as lesions that demonstrated persistent enhancement and/or did not decrease in size within 6 months of therapy. RESULTS: A total of 47 lesions in 45 patients were identified. The median follow-up was 13 months. Mean lesion size was 2.7 cm (range, 1.2-5.4), with 25 anterior and 22 lateral or posterior lesions. Of the biopsy samples from 40 of 47 lesions, renal cell carcinoma was found in 23, oncocytoma was found in 7, and 10 were benign or inconclusive. Treatment failure was noted in 8 of 47 lesions (17%), 7 of which (87.5% of failed lesions) had broad-based contact with the renal sinus. Broad-based lesions which made contact with the renal sinus were successfully treated 53.3% of the time, whereas lesions which lacked contact with the renal sinus were treated successfully 96.9% of the time (P <.01). CONCLUSIONS: Broad-based central location of a renal mass may predict a significantly increased risk of failure of LRC and should be considered in patient counseling.

Serum testosterone recovery after cessation of long-term luteinizing hormone-releasing hormone agonist in patients with prostate cancer.

OBJECTIVES: The time to testosterone recovery after the cessation of androgen deprivation therapy appears to be dependent on the therapy duration. Most men will recover normal testosterone levels within 18 months according to the findings from studies that frequently involved fewer than 3 years of androgen deprivation therapy. Our goal was to assess the proportion of patients who remain castrated after cessation of longer duration luteinizing hormone-releasing hormone (LHRH) agonist therapy for prostate cancer. METHODS: We reviewed 15 patients who had received at least 48 months of continuous goserelin injection therapy for prostate cancer and had not been receiving the therapy for at least 18 months. The serum testosterone and prostate-specific antigen data were obtained. RESULTS: The mean duration of LHRH agonist therapy was 73 months (range 48 to 110). At the cessation of therapy after a mean follow-up of 31 months, 53% had testosterone levels that remained castrated. Only 1 patient achieved normal testosterone levels. Of the patients with greater than castrate testosterone levels, 71% experienced a prostate-specific antigen rise. All the men with an intact prostate who had testosterone recovery to greater than castrate levels had a prostate-specific antigen increase, which might represent a return toward the pretreatment baseline. Of the patients who started therapy after age 70 years, 78% remained castrated versus 17% of those who started before 70 years. CONCLUSIONS: Of the men who had received 4 or more years of LHRH agonist therapy for prostate cancer, 53% remained castrated up to 2.5 years after therapy cessation. Patients who started LHRH agonist therapy after age 70 were more likely to remain castrate after stopping long-term therapy.

Multiple/bilateral renal tumors in patients with Birt-Hogg-Dubé syndrome.

OBJECTIVE: To describe our findings in four patients with multiple/bilateral renal cell carcinoma (RCC) and Birt-Hogg-Dubé (BHD) syndrome. PATIENTS AND METHODS: A series of four patients with BHD syndrome and RCC is analyzed. Patient charts were reviewed for age, sex, presentation, various clinical manifestations, imaging, management and outcome. RESULTS: Patients included 2 males and 2 females. Age ranged from 40 to 65 years (mean 56 years). The interval between the diagnosis of skin lesions characteristic of the disease and the development of renal tumors ranged between 1 and 35 years. Three of the patients had bilateral renal tumors (2 synchronous and one metachronous), one patient had multiple renal tumors in one kidney. In one patient the renal mass was diagnosed with a screening CT scan of the abdomen after the diagnosis of BHD syndrome. One patient had associated spontaneous pneumothorax and thyroid tumor. Only one of the 4 patients had prior family history of BHD syndrome. Renal tumors were clear cell type in 3 patients, and chromophobe tumor in one. Tumor size ranged from 2 to 9 cm. CONCLUSION: BHD syndrome is associated with multiple diseases and tumors. We describe four patients with BHD syndrome with multiple or bilateral RCC. Two of the patients were asymptomatic. A high index of suspicion should be present in patients who present with the characteristic skin lesions of BHD syndrome and screening for the presence of renal tumors should be done in those patients. Long term follow up is necessary after treating renal tumors in these patients.

Salvage cryosurgical ablation of the prostate for local recurrence after radiation therapy: improved outcomes utilizing a capromab pendetide scan and biopsy algorithm.

PURPOSE: We assessed the efficacy, complications and technical advancements in salvage cryosurgical ablation of the prostate for recurrent prostate cancer after radiation therapy. METHODS: A total of 58 patients were evaluated for salvage cryosurgery using an algorithm of capromab pendetide scan and prostate biopsy from January 2003-July 2007. Forty-seven patients underwent salvage cryosurgery and biochemical recurrence free survival and complications were retrospectively reviewed. Mean follow-up was 24 months. RESULTS: Seventy percent of patients achieved a nadir PSA < 0.5 ng/ml. Overall, 51% of patients achieved a durable PSA response with a pre-salvage serum PSA < 10 predictive of success. There were no major complications and minor complications were few. CONCLUSION: Salvage cryotherapy in experienced hands utilizing third-generation technology provides for excellent biochemical control with minimal morbidity.

Improving oversight of the graduate medical education enterprise: one institution's strategies and tools.

Accreditation organizations, financial stakeholders, legal systems, and regulatory agencies have increased the need for accountability in educational processes and curricular outcomes of graduate medical education. This demand for greater programmatic monitoring has placed pressure on institutions with graduate medical education (GME) programs to develop greater oversight of these programs. Meeting these challenges requires development of new GME management strategies and tools for institutional GME administrators to scrutinize programs, while still allowing these programs the autonomy to develop and implement educational methods to meet their unique training needs. At the Medical University of South Carolina (MUSC), senior administrators in the college of medicine felt electronic information management was a critical strategy for success and thus proceeded to carefully select an electronic residency management system (ERMS) to provide functionality for both individual programs and the GME enterprise as a whole. Initial plans in 2002 for a phased deployment had to be changed to a much more rapid deployment due to regulatory issues. Extensive communication and cooperation among MUSC's GME leaders resulted in a successful deployment in 2003. Evaluation completion rates have substantially improved, duty hours are carefully monitored, patient safety has improved through more careful oversight of residents' procedural privileges, regulators have been pleased, and central GME administrative visibility of program performance has dramatically improved. The system is now being expanded to MUSC's medical school and other health professions colleges. The authors discuss lessons learned and opportunities and challenges ahead, which include improving tracking of development of procedural competency, establishing and monitoring program performance standards, and integrating the ERMS with GME reimbursement systems.

The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.

BACKGROUND: Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists (alpha-blockers) or 5alpha-reductase inhibitors. The long-term effect of these drugs, singly or combined, on the risk of clinical progression is unknown. METHODS: We conducted a long-term, double-blind trial (mean follow-up, 4.5 years) involving 3047 men to compare the effects of placebo, doxazosin, finasteride, and combination therapy on measures of the clinical progression of benign prostatic hyperplasia. RESULTS: The risk of overall clinical progression--defined as an increase above base line of at least 4 points in the American Urological Association symptom score, acute urinary retention, urinary incontinence, renal insufficiency, or recurrent urinary tract infection--was significantly reduced by doxazosin (39 percent risk reduction, P<0.001) and finasteride (34 percent risk reduction, P=0.002), as compared with placebo. The reduction in risk associated with combination therapy (66 percent for the comparison with placebo, P<0.001) was significantly greater than that associated with doxazosin (P<0.001) or finasteride (P<0.001) alone. The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy (P<0.001) and finasteride (P<0.001) but not by doxazosin. Doxazosin (P<0.001), finasteride (P=0.001), and combination therapy (P<0.001) each resulted in significant improvement in symptom scores, with combination therapy being superior to both doxazosin (P=0.006) and finasteride (P<0.001) alone. CONCLUSIONS: Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone. Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy.

Complete bladder, urethral, and vaginal duplication in a 50-year-old woman.

We present a rare case of a 50-year-old woman with complete bladder, urethral, and vaginal duplication without previous urogenital system reconstruction. Our patient demonstrated a rare embryologic defect with complete bladder, urethral, and vaginal duplication without any functional dysfunction. She was able to reach adulthood without reconstructive surgery. This case allowed the unique opportunity of evaluating these urogenital anomalies at a later point in life.

Recruitment for a clinical trial of drug treatment for benign prostatic hyperplasia.

OBJECTIVES: To evaluate the effectiveness of various recruitment strategies for a 6-year multicenter clinical trial of medical therapy for benign prostatic hyperplasia, the Medical Therapy of Prostatic Symptoms Trial. METHODS: How participants learned about the trial was obtained during initial contact with clinical centers and at the first screening visit. The yield of randomized participants from the initial contact and first screening visit was calculated for each of the recruitment techniques. RESULTS: During a period of 28 months, 16,723 potential trial participants made an initial contact with the 17 clinical centers, and 2931 men were randomized. An average of four initial contacts were required for each first screen visit and six per randomized participant. Newspaper (29.9%) and mail (26.7%) were the two leading sources of randomized participants. Medical sources (9.6%), radio (8.8%), and newsletters (8.4%) were also important sources. All clinical centers achieved or exceeded their recruitment goals. CONCLUSIONS: Mass mail and newspaper were the most effective recruitment techniques to enlist the interest of men with urinary symptoms for a long-term trial of drug therapy for benign prostatic hyperplasia.