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Query: UMLS:C0376358 (prostate cancer)
 59,338 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

In addition to the normal aspects of organizing clinical trials, the launch of a chemoprevention trial on prostate cancer needs extra effort. The sample size and duration of follow-up is so extensive that such a trial should be organized as an intergroup study, preferably worldwide. For that a central data center and data management is mandatory. Because healthy individuals are involved, refusal, loss to follow-up and inadequate adherence may be substantial. The choice of the study endpoint presence of prostate cancer or death due to prostate cancer will lead to completely different sample sizes and length of follow-up. Of criteria leading to the diagnosis of prostate cancer (PSA, DRE and transrectal ultrasound), at least two are rather subjective. The drug involved might affect the criteria for diagnosis. Because of the high incidence of clinically nonsignificant prostate cancer of men over 55, a large number of nonrelevant prostate cancers will be detected in both arms. Due to the long follow-up and alterations in the state of the art of detection and therapy of prostate cancer, the completion of such a study might be hampered. If the average price per patient involved in a clinical trial is currently between USD 1, 000 and 2,000, one may calculate that for 30,000 men, USD 20-40 million are needed, not including the hospital visits, examinations and biopsies. Economic considerations thus play a major role in organizing trials on the chemoprevention of prostate cancer.
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PMID:Practical aspects of clinical trials on chemoprevention of prostate cancer. 1032 17

It is well known that African American men are more likely to be diagnosed with metastatic prostate cancer than White men. Racial variation in the use of prostate cancer early detection modalities (ie, digital rectal examination [DRE] and prostate-specific antigen [PSA] testing) has been suggested as a major reason for this differential. Several factors may help to explain the reported low levels of DRE and PSA test utilization among African American men, including background sociodemographic characteristics, medical history, and cognitive and psychosocial perceptions. In this review, the impact of these characteristics on prostate cancer early detection examination utilization is explored. Findings from studies showing race-related differences in cognitive and psychosocial factors are presented. Preparatory education for informed decision-making is suggested as an approach to help minimize racial differences in cognitive and psychosocial factors that influence the use of prostate cancer early detection modalities. The need to facilitate informed decision-making along the continuum of care is highlighted.
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PMID:African American men, prostate cancer early detection examination use, and informed decision-making. 1048 80

Presentation of our experience in the early diagnosis of prostate cancer in patients with signs and symptoms of prostatism. Over a one year period (96-97), 316 patients underwent biopsy based on clearly defined criteria according to the diagnostic algorithm used in our centre: suspicious DRE and/or PSA > or = 10 ng/mL, and in patients with PSA between 4 and 10 ng/mL in the presence of suspicious TRU or when DPSA was > or = 0.15. The ratio of the 136 (43%) prostate cancer diagnosed relative to biopsy +/- was 1:1.32. It is concluded that early diagnosis in a selected population is useful and shows good diagnostic yield. The diagnostic algorithm used is more than acceptable with 43% positive biopsies and a good ratio between biopsy +/-. With a cutoff of 0.15 DPSA is a good method to improve PSA significance in patients in the difficult PSA range of 4 to 10 ng/mL.
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PMID:[Early diagnosis of prostate cancer in patients with prostate symptoms by DRE, PSA, TRU and DPSA]. 1058 46

Refinement in the local staging and risk assessment for prostate cancer patients utilizing clinical parameters is ongoing. DRE, tumor grade, and PSA provide some useful information for risk assessment in individual patients. More recent studies using percent free PSA levels and systematic biopsy results have added additional staging information and may play a more significant role in the future in risk assessment. This information should supplement additional imaging tests in the management of these patients.
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PMID:Prostate cancer: assessment of risk using digital rectal examination, tumor grade, prostate-specific antigen, and systematic biopsy. 1066 66

The use of PSA-density (PSAD) as an indicator for prostate biopsy at intermediate PSA values has generated controversy. There are investigators who consider that the determination of PSAD is futile, and that it is better to do a prostate biopsy based on PSA values alone, TRUS (Transrectal Ultrasound) findings and/or DRE examinations. Asian countries, especially in the Far East, are considered to have a low incidence of prostate cancer (PCa). However, based on western references, we still measure PSA-density with a cut-off level of 0.15 to promote prostate biopsy in patients with intermediate PSA values (4.1-10.0 ng/ml). Our study aims to evaluate the usefulness of PSAD as an indication for biopsy in patients with intermediate serum PSA values. To evaluate the usefulness of this indicator, we conducted a retrospective study of 132 uncatheterized (to minimize potential bias) BPH and PCa cases that were hospitalized in our department between 1995-1997 (3 years). This group comprised 127 BPH and 5 PCa patients. Mean age was 66.1 +/- 7.69 years; mean PSA was 7.92 +/- 9.289 ng/ml; mean prostate volume was 54.1 +/- 26.72 cc; mean PSAD was 0.15 +/- 0.185. More specifically, there were 49 patients with intermediate PSA values (47 BPH & 2 PCa). The receiver operator characteristic (ROC) curve revealed an optimum cut-off level of 0.19. At this level of PSA density, the measured sensitivity was 100% with a specificity of 79%. We concluded that, in our uncatheterized patients (without retention) series, the PSAD cut-off level for prostate biopsy (0.19) was higher than that in the western world (0.12 or 0.15).
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PMID:A higher PSA-density cut-off level in patients with intermediate PSA values for the early detection of prostate cancer. 1089 3

Early diagnosis of prostate cancer is best achieved using a combination of DRE and PSA as first-line tests to detect signs of prostate cancer. Because DRE and PSA do not always detect the same cancer, the tests are complementary. Among men with elevated PSA who are negative on DRE, the chance of cancer ranges from 12 to 32%. Most men with PSA elevations do not have cancer. This high false-positive rate among men without cancer has led to many approaches to decrease the incidence of false-positive test results, including PSA density, transition zone PSA density, PSA velocity, age-specific PSA reference ranges and percent free PSA.
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PMID:[Prostate specific antigen: a role of PSA in the diagnosis of prostate cancer]. 1176 72

DRE has been used as a diagnostic and screening tool for prostate cancer for decades. However these are based on Western data and its local applicability has yet to be verified. We held a Prostate Health Awareness Week in August 1998 and a total of 2086 men were screened. All men aged 50 years old and above were included for the study. The subjects were evaluated on DRE findings, PSA levels and if indicated a TRUS-guided biopsy results. We concluded that DRE per se might have limited role in the screening of prostate cancer in Malaysia. Screening using DRE and PSA combined are still recognized as the most cost-effective means. Neither DRE nor PSA alone has high enough specificity for diagnosis of prostate cancer cases. Combining DRE and PSA will definitely increase the specificity significantly.
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PMID:The role of DRE in the diagnosis of prostate carcinoma. 1177 Oct 76

Our study was performed to evaluate the diagnostic usefulness of %fPSA alone and combined with an ANN at different PSA concentration ranges, including the low range 2-4 ng/ml, to improve the risk assessment of prostate cancer. A total of 928 men with prostate cancer and BPH without any pretreatment of the prostate in the PSA range 2-20 ng/ml were enrolled in the study between 1996 and 2001. An ANN with input data of PSA, %fPSA, patient's age, prostate volume and DRE status was developed to calculate the individual's risk before performing a prostate biopsy within the different PSA ranges 2-4, 4.1-10 and 10.1-20 ng/ml. ROC analysis and cut-off calculations were used to estimate the diagnostic improvement of %fPSA and ANN in comparison to PSA. At the 90% sensitivity level, %fPSA and ANN performed better than PSA in all ranges, enhancing the specificity by 15-28% and 32-44%, respectively. For the low PSA range 2-4 ng/mL, we recommend a first-time biopsy at an ANN specificity level of 90%. For PSA 4-10 ng/mL, we recommend a first-time biopsy based on the ANN at the 90% sensitivity level. Use of an ANN enhances the %fPSA performance to further reduce the number of unnecessary biopsies within the PSA range 2-10 ng/ml.
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PMID:An artificial neural network considerably improves the diagnostic power of percent free prostate-specific antigen in prostate cancer diagnosis: results of a 5-year investigation. 1199 19

Prostate cancer is the commonest non-skin malignancy in the United States and has a substantial mortality rate despite the use of PSA-based screening. Furthermore, therapy for prostate cancer by surgery, radiotherapy or hormonal manipulation carries a significant risk of treatment-related morbidity. Recent analysis of secondary endpoints of several large-scale randomized prospective clinical trials for other malignancies has suggested that selenium or vitamin E may result in a decreased incidence and mortality from prostate cancer. In vitro and preclinical studies of these antioxidants support this hypothesis. This review outlines the rationale and design of SELECT, the Selenium and Vitamin E Cancer Prevention Trial, designed to test the hypothesis that selenium or vitamin E alone or in combination can reduce the clinical incidence of prostate cancer in a population-based cohort of men at risk. SELECT is a phase III, randomized, double-blinded, prospective, 2x2 factorial clinical trial which will randomize 32,400 healthy men with normal DRE and serum PSA to one of four study arms: selenium alone, vitamin E alone, selenium+vitamin E, or placebo. Study agents will be taken orally for a minimum of 7 and maximum of 12 y with assessments of general health, incident prostate cancer and toxicity performed at 12 month intervals. Under the assumptions described, the detectable risk reduction is 25% for an effective single agent relative to placebo, with an additional 25% reduction for the combination relative to an effective single agent. The estimated power for the comparison of a single agent vs placebo is 96% and the power for the comparison of an effective single agent vs combination is 89%. Secondary endpoints will include prostate cancer-free survival, all-cause mortality, and the incidence and mortality of other cancers and diseases potentially impacted by the chronic use of selenium and vitamin E. Other trial objectives will include periodic quality of life assessments, assessment of serum micronutrient levels and prostate cancer risk, and studies of the evaluation of biological and genetic markers with the risk of prostate cancer. Prostate Cancer and Prostatic Diseases (2000) 3, 145-151
Prostate Cancer Prostatic Dis 2000 Nov
PMID:SELECT: the Selenium and Vitamin E Cancer Prevention Trial: rationale and design. 1249 90

A family history is one of the strongest risk factors for prostate cancer (PC). We evaluated the detection rate of PC in relatives of 119 German PC families that took part in ongoing linkage analyses. Brothers of patients with sporadic prostate cancer aged < 55 years at onset were included as well. Responses were received from 120/196 (61.2%) individuals of the familial and 67/120 (55.8%) of the sporadic group. Findings (DRE, TRUS, PSA) were more often suspicious for carcinoma in the PC families. Prostate cancer was diagnosed in 6 (5.0%) and 2 (2.99%) participants of the familial and the sporadic group, respectively. These detection rates tended to be higher than that of an age-matched subgroup of an unselected population in other European screening studies. The most important risk factor for the diagnosis of PC was a low average age at onset within the family. These data imply that prostate cancer screening in the high-risk group of men with familial predisposition cannot be assessed by population-based studies and should be evaluated separately.
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PMID:[Preventing prostate carcinoma in men with familial disposition]. 1252 47


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