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G W Chodak

Publications and source records attributed to G W Chodak.

At least 19 recordsLinked to original sources

Using outcome data and patient satisfaction surveys to develop policies regarding minimum length of hospitalization after radical prostatectomy.

OBJECTIVES: Changes in health care economics have prompted new clinical pathways for radical prostatectomy to reduce length of hospitalization after surgery to 1 day. We evaluated satisfaction, outcomes, and short-term morbidity in 187 consecutive patients with overnight hospitalization after radical retropubic prostatectomy (RRP). METHODS: In 1995, we initiated a critical pathway for RRP that included epidural anesthesia with or without spinal anesthesia and postoperative methadone, acetaminophen, and ibuprofen for pain control. Patients were discharged when they were afebrile, tolerating a regular diet, ambulating without assistance, and using oral medications for analgesia. An 18-item satisfaction survey was mailed to each patient 3 weeks after discharge. Responses to the postoperative survey, morbidity, blood loss, and use of transfusions were recorded. RESULTS: Of 252 patients who underwent RRP, 187 (74. 2%) were discharged 1 day after surgery. The mean age of patients was 61.4 years (range 42 to 73). A pelvic lymphadenectomy was performed in addition to the RRP in 32 men (17%). Epidural anesthesia with or without spinal anesthesia was used for all but 3 patients. The mean estimated blood loss was 1166 mL, and 24 patients (12.8%) required transfusion, with a mean of 1.9 U (range 1 to 6) of packed red blood cells. The postoperative complication rate was 11. 8%, of which 2.1% (n = 4) were definitely or probably related to our protocol. These complications included clot retention (n = 2), gastrointestinal bleeding (n = 1), and spinal headache (n = 1). Three of 187 patients were readmitted to the hospital within 30 days but only one (0.5%) required admission because of our protocol. The survey response rate was 91.4%. No patient was dissatisfied with his overall care, and only 10.5% of patients would have preferred to stay in the hospital longer. CONCLUSIONS: One-day hospitalization after RRP is associated with minimal postoperative morbidity and high patient satisfaction. Similar data are needed for RRP from other centers before policy decisions regarding the length of stay after this procedure are made.

Adult↗

Adherence by African American men to prostate cancer education and early detection.

BACKGROUND: This study was designed to identify factors that predict adherence by African American men to prostate cancer education and early detection. METHODS: In the spring of 1995, the authors identified 548 African American men who were patients at the University Health Services of the University of Chicago, were ages 40-70 years, and did not have a personal history of prostate cancer. Baseline telephone survey data were collected from 413 men (75%). Participants were randomly assigned to either a minimal or an enhanced intervention group. Men in the former group were mailed a letter and a reminder that invited them to a urology clinic for prostate cancer education and early detection. Men in the enhanced intervention group were sent the same correspondence and were also given print material and telephone contacts, which were tailored to each recipient. RESULTS: Adherence was significantly higher (OR = 2.6, CI: 1.7-3.9) in the enhanced intervention group than in the minimal intervention group (51% and 29%, respectively). Men who were age 50 years or older (OR = 1.7, CI: 1.1-2.8), were married (OR = 1.8, CI: 1.2-2.9), believed that prostate cancer early detection examination should be performed in the absence of symptoms (OR = 2.3, CI: 1.3-4.0), and self-reported an intention to have an early detection examination (OR = 1.9, CI: 1.2-2.9) were also more likely to adhere. CONCLUSIONS: A tailored behavioral intervention can influence adherence to prostate cancer early detection among African American men. Individual background and cognitive and psychosocial characteristics may also affect behavior. Future studies should assess the impact of this type of intervention on cognitive and psychologic correlates of decision-making and behavior along the continuum of prostate cancer care. [See editorial on pages 1-2, this issue.]

Adult↗

Endocrine effects, efficacy and tolerability of a 10.8-mg depot formulation of goserelin acetate administered every 13 weeks to patients with advanced prostate cancer.

OBJECTIVE: To determine the endocrine effects, efficacy and tolerability of a 10.8-mg depot formulation of Zoladextrade mark (goserelin acetate, Zeneca Pharmaceuticals, Wilmington, Delaware, USA), a luteinizing hormone-releasing hormone agonist analogue, when administration was extended from every 12 weeks to every 13 weeks in patients with advanced prostate cancer. PATIENTS AND METHODS: Between July 1995 and May 1996, 59 patients with either locally advanced (T3 or T4) or metastatic prostate cancer were enrolled in an open-label, multicentre trial. Primary efficacy endpoints were testosterone measurements, and assessments of prostate specific antigen (PSA) response, subjective and objective response. Quality of life (QoL) was a secondary efficacy endpoint. RESULTS: Mean testosterone concentrations decreased to < 0.3 microgram/L by week 4 and remained so for the duration of treatment. There were no statistically significant differences in mean testosterone levels between weeks 12 and 13, or weeks 25 and 26. Serum testosterone suppression was adequate in all 58 evaluable patients at week 13, and 51 of 52 (98%) patients at week 26. Of the 58 evaluable patients, 52 (90%) had a PSA response. A subjective response was recorded for six of 11 evaluable patients. Of 58 patients evaluable for objective response, 46 (79%) had a partial response, three (5%) had stable disease and nine (16%) had objective progression. Except for a significant (P=0.014) decrease in overall sexual interest, QoL was unchanged during therapy. The most common side-effects, regardless of causality, were hot flushes (67%), pain (31%) and pelvic pain (22%). Mild injection-site complaints occurred with only three of 221 (1.4%) depot injections. CONCLUSIONS: Zoladextrade mark 10.8-mg depot, administered every 13 weeks to patients with advanced prostatic cancer, is well tolerated, provides adequate suppression of serum testosterone and produces PSA, subjective and objective responses.

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Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms.

OBJECTIVES: To assess the effects of saw palmetto on voiding symptoms and urodynamic parameters in men with lower urinary tract symptoms (LUTS) presumed secondary to benign prostatic hyperplasia (BPH). METHODS: Fifty men with previously untreated LUTS and a minimum International Prostate Symptom Score (IPSS) of 10 or greater were treated with a commercially available form of saw palmetto (160 mg twice per day) for 6 months. The initial evaluation included measurement of peak urinary flow rate, postvoid residual urine volume, pressure-flow study, and serum prostate-specific antigen (PSA) level. Patients completed an IPSS, serum PSA was determined, and flow rate was measured every 2 months during the course of the study. A urodynamic evaluation was repeated at the completion of the 6-month trial. RESULTS: The mean IPSS (+/-SD) improved from 19.5+/-5.5 to 12.5+/-7.0 (P <0.001) among the 46 men who completed the study. Significant improvement in the symptom score was noted after treatment with saw palmetto for 2 months. An improvement in symptom score of 50% or greater after treatment with saw palmetto for 2, 4, and 6 months was noted in 21% (10 of 48), 30% (14 of 47), and 46% (21 of 46) of patients, respectively. There was no significant change in peak urinary flow rate, postvoid residual urine volume, or detrusor pressure at peak flow among patients completing the study. No significant change in mean serum PSA level was noted. CONCLUSIONS: Saw palmetto is a well-tolerated agent that may significantly improve lower urinary tract symptoms in men with BPH. However, we were unable to demonstrate any significant improvement in objective measures of bladder outlet obstruction. Placebo-controlled trials of saw palmetto are needed to evaluate the true effectiveness of this compound.

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Comparison of goserelin and leuprolide in combined androgen blockade therapy.

OBJECTIVES: To perform exploratory analyses of data from a controlled trial that assessed the efficacy and tolerability of two antiandrogens, bicalutamide and flutamide, each combined with monthly depot preparations of leuprolide or goserelin, in patients with Stage D2 prostate cancer. One analysis compared goserelin plus antiandrogen therapy with leuprolide plus antiandrogen therapy; a second analysis compared the four combined androgen blockade (CAB) regimens. METHODS: This was a randomized, multicenter trial, open-label for luteinizing hormone releasing hormone analogue (LHRH-A) therapy, double-blind for antiandrogen therapy, with a two-by-two factorial design. Eight-hundred thirteen patients were allocated in a ratio of 2:1 to goserelin therapy (3.6 mg every 28 days) or leuprolide therapy (7.5 mg every 28 days) and 1:1 to bicalutamide therapy (50 mg once a day) or flutamide therapy (250 mg three times a day). The end points of time to progression and survival were assessed with a median of 160 weeks of follow-up. RESULTS: The percentages of progression events (70.9% versus 73.3%) and deaths (54.3% versus 56.8%) were similar for goserelin plus antiandrogen and leuprolide plus antiandrogen therapies. The hazard ratios for goserelin plus antiandrogen therapy to leuprolide plus antiandrogen therapy were 0.99 (95% confidence interval [CI] 0.84 to 1.18; P = 0.92) and 0.91 (95% CI 0.75 to 1.11; P = 0.34) for time to progression and survival, respectively. Goserelin plus antiandrogen and leuprolide plus antiandrogen therapies were generally well tolerated, and the side effects associated with depot administration occurred with a low frequency in the two groups. There were no significant differences among the goserelin plus bicalutamide, goserelin plus flutamide, or leuprolide plus bicalutamide therapy groups, but leuprolide plus flutamide therapy had a significantly poorer outcome than the other three therapies. The side-effect profiles for the four CAB groups were generally similar; diarrhea was more common among patients treated with flutamide and hematuria was more common among patients treated with bicalutamide. CONCLUSIONS: Although the results of these exploratory analyses should be interpreted with caution, they indicate that goserelin plus antiandrogen and leuprolide plus antiandrogen therapies are similarly well tolerated and have equivalent time to progression and survival, and that leuprolide plus flutamide therapy appears to be the least effective of the four CAB regimens.

Adult↗

Overnight hospitalization after radical prostatectomy: the impact of two clinical pathways on patient satisfaction, length of hospitalization, and morbidity.

UNLABELLED: Changes in health care have prompted efforts to reduce length of hospitalization while maintaining quality care. Therefore, we evaluated short-term outcomes after radical retropubic prostatectomy on 100 consecutive men undergoing surgery for clinically localized prostate cancer performed under epidural anesthesia followed by epidural morphine or combined with spinal anesthesia using bupivacaine and fentanyl (25 micrograms) and followed by i.m. methadone (10-20 mg). All patients received oral acetaminophen and ibuprofen beginning 4 h after surgery. Length of hospital stay, responses to written satisfaction survey, postoperative morbidity and readmission to the hospital were recorded. Using either pathway, 83% of the patients were discharged after one night in the hospital. The mean hospital stay was 1.34 +/- 1.10 and 1.28 +/- 1.0 days, respectively. Although three men were rehospitalized, it was not because of the early discharge. More than 95% of patients were satisfied with pain control, and patients discharged after one night were not more likely to be dissatisfied than patients hospitalized longer. IMPLICATIONS: Both clinical pathways provide excellent anesthesia and analgesia and allow discharge 1 day after radical retropubic prostatectomy. Shortened hospital stay does not increase patient dissatisfaction or add to postoperative morbidity. Patients undergoing other pelvic and abdominal operations may also derive similar benefits using these pathways.

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Evaluation of changes in prostate specific antigen in clinically localized prostate cancer managed without initial therapy.

PURPOSE: We define changes in prostate specific antigen (PSA) measurements with time in 49 men 71.9 +/- 7.0 years old (mean plus or minus standard deviation) with clinically localized prostate cancer who remain untreated. MATERIALS AND METHODS: We retrospectively analyzed PSA changes in prostate cancer patients managed by watchful waiting. In all patients a minimum of 3 PSA levels were measured at intervals of at least 6 months after malignancy was diagnosed. The rate of change in serum PSA level with time (PSA velocity) was determined using an exponential, log linear model. RESULTS: In 49 patients treated conservatively mean initial PSA level plus or minus standard deviation was 12.3 +/- 11.1 ng./ml. and mean PSA followup during which no therapy for prostate cancer was introduced was 32.1 +/- 13.2 months. PSA levels decreased during the observation period in 11 of the 49 patients (22%) and median PSA doubling time in the remaining 38 was 55.7 months (range 15.1 to 994.5). There was no significant correlation between age at diagnosis, Gleason sum, initial PSA level or clinical stage and PSA velocity. The short-term rate of change in PSA during the first 9 months after prostate cancer was diagnosed correlated poorly with overall PSA velocity. The short-term rate of PSA change was greater than the overall rate of change in 14 of 37 patients (38%). CONCLUSIONS: There is significant variability in the rate of change of PSA with time in men with clinically localized prostate cancer who remain untreated. The usefulness of serial PSA measurements in the management of watchful waiting is unclear. Changes in PSA may not be helpful or appropriate in determining the need for therapy after a period of observation.

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Prostate cancer.

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Biopsy↗

Improved detection of recurrent bladder cancer using the Bard BTA stat Test.

OBJECTIVES: To evaluate the BTA stat Test in the detection of recurrent bladder cancer. METHODS: Sensitivity and specificity were determined using frozen voided urine samples from patients with recurrent bladder cancer, volunteers, patients with nonurologic conditions, and patients with a history of bladder cancer but free of disease. Results of cytology and the original BTA Test were compared with the sensitivity of the BTA stat Test in a large subgroup of the patients with cancer. RESULTS: The BTA stat Test detected 147 (67%) of 220 recurrent cancers. For those urine samples with previous cytologic and BTA Test results available, cytology had a sensitivity of 23%, the BTA Test 44%, and the BTA stat Test 58% for detection of recurrent cancer (P < 0.001, stat versus cytology). The specificity of the BTA stat Test was 72% for benign genitourinary disease and 95% in healthy volunteers. CONCLUSIONS: The BTA stat Test has high sensitivity and is significantly superior to voided urine cytologic analysis in the detection of recurrent bladder cancer.

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Results of radical prostatectomy in men with locally advanced prostate cancer: multi-institutional pooled analysis.

OBJECTIVE: We investigated the disease-specific and metastasis-free survival rates in men with locally advanced (clinical stage T3) prostate cancer who were treated surgically. METHODS: A retrospective, multi-institutional pooled analysis of the results of surgical treatment in 345 men with clinical stage T3 disease was performed. Survival curves were generated using the Kaplan-Meier method. RESULTS: Among 298 evaluable patients, pelvic lymphadenectomy alone was performed in 56 men (19%), while 242 men (81%) underwent node dissection and radical prostatectomy. In total, 122 of 298 patients (41%) had nodal metastases and/or seminal vesicle tumor spread. Pathologically organ-confined disease was noted in 27 men (9%). The actuarial 10-year disease-specific and metastasis-free survival rates for all patients managed surgically were 57 and 32%, respectively. For patients with well, moderately and poorly differentiated tumors, cancer-specific survival rates at 10 years were 73, 67 and 29%, respectively. CONCLUSIONS: A large number of men with clinical stage T3 prostate cancer have advanced disease and are unlikely to achieve improved long-term survival with surgery alone. Although there may be a role for radical prostatectomy in selected patients with low to intermediate grade tumors, such treatment appears unlikely to result in long-term survival in men with high grade disease. A prospective study is necessary to determine the optimal treatment approach in men with locally advanced prostate cancer.

Adult↗

Results of radical prostatectomy in men with clinically localized prostate cancer.

OBJECTIVE: To assess the results of radical prostatectomy in men with early prostate cancer. DESIGN: Retrospective, nonrandomized, multi-institutional pooled analysis. SETTING: Eight university medical centers in the United States and Europe. PATIENTS: A total of 2758 men with stage Tl and T2 prostatic cancer. MAIN OUTCOME MEASURES: Disease-specific and metastasis-free survival rates. RESULTS: Tumor grade was the most important preoperative factor in determining outcome. Disease-specific survival 10 years following surgery and associated 95% confidence intervals were 94% (range, 87%-98%), 80% (range, 74%-85%), and 77% (range, 65%-86%) for those men with grade 1, 2, and 3 tumors, respectively. Metastasis-free survival at 10 years was 87% (range, 78%-92%), 68% (range, 62%-73%), and 52% (range, 38%-64%) for patients with grade 1, 2, and 3 cancers, respectively. CONCLUSIONS: Radical prostatectomy leads to high 10-year disease-specific survival rates in men with all tumor grades. However, caution is needed in comparing these results with similar studies of alternative treatment strategies, such as watchful waiting, due to the inherent potential biases in uncontrolled trials. Nevertheless, these results offer the best currently available estimates of 10-year outcome of radical prostatectomy in men with clinically localized prostate cancer and may be useful in counseling patients with early malignancy.

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Bicalutamide in the treatment of advanced prostatic carcinoma: a phase II multicenter trial.

OBJECTIVES: The safety, efficacy, and pharmacokinetics of the nonsteroidal antiandrogen bicalutamide were investigated in a Phase II trial in 150 patients with metastatic prostate cancer. METHODS: Patients took bicalutamide, 50 mg daily, in an open-label multicenter North American trial. RESULTS: The objective response rate (modified European Organization on Research and Treatment of Cancer [EORTC] criteria) was 70% (57% partial, 13% stable); 59 (39%) of 150 patients had either a > 90% decrease in prostate-specific antigen (PSA) levels or a decline to < 4 ng/mL. Extent of disease on the bone scan was a significant predictor of response. Patients with < 6 metastatic lesions were more likely to respond. Breast pain and gynecomastia occurred in 76% and 60% of patients, respectively. Gastrointestinal toxicity was very infrequent (diarrhea, 5%) The mean drug plasma concentration was 8528 (+/- 2928) ng/mL. CONCLUSIONS: Bicalutamide, 50 mg daily, was well tolerated and has efficacy in metastatic prostate cancer. The percentage of men who had > 90% decline in PSA levels is less than observed with surgical or medical castration and has led to trials using this antiandrogen at higher doses as monotherapy.

Acid Phosphatase↗

A controlled trial of bicalutamide versus castration in patients with advanced prostate cancer.

OBJECTIVES: Bicalutamide is a new, potent antiandrogen with potential efficacy in the treatment of men with advanced prostate cancer. Although no pure antiandrogen has been well studied versus castration, potentially fewer adverse effects could occur, making such an agent a potentially useful alternative therapy. To date, three randomized controlled trials have been performed comparing these two treatments. In preliminary studies, a dose of 50 mg bicalutamide per day was selected for these trials. In two of the studies (0302, 0303), this drug was compared to either medical or surgical castration, the latter choice being made by the patient. In the third study (0301), bicalutamide was compared to bilateral orchiectomy. METHODS: Using an intention-to-treat format, the outcomes assessed were time-to-treatment failure, time-to-objective disease progression, subjective response, and survival time in men with previously untreated metastatic disease. The incidence of breast tenderness, gynecomastia, and hot flushes was also determined in both treatment arms. A quality-of-life questionnaire was administered on multiple occasions after initiation of therapy. RESULTS: Based on an analysis of > 1000 patients, the objective and subjective results favored castration over bicalutamide (50 mg/day). The hazard ratios for time-to-treatment failure (1.59), time-to-disease progression (1.62), and median survival (1.44) were all significantly greater in the castration group (P > 0.001). Another difference noted at 3 months was a significantly lower median fall in prostate-specific antigen values in the bicalutamide group (86-88% versus 96-97%). Symptomatic patients receiving bicalutamide were only 0.43 times as likely to have subjective improvement as the patients treated by castration. A comparison of pharmacologic effects showed that only the incidence of hot flushes was lower in the bicalutamide group, whereas breast tenderness and gynecomastia were more common. This difference in hot flushes, however, translated into better quality of life during the first several months with regard to sexual relations and sexual functioning. CONCLUSIONS: Bicalutamide monotherapy at 50 mg/day appears inferior to castration in overall objective and subjective response rates. Whether higher doses of bicalutamide can compete more favorably will need to be tested in further clinical trials.

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