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Monique J Roobol

Publications and source records attributed to Monique J Roobol.

At least 19 recordsLinked to original sources
PubMed2007

Screening for prostate cancer at low PSA range: the impact of digital rectal examination on tumor incidence and tumor characteristics.

OBJECTIVES: To compare tumor characteristics of screen-detected prostate cancers (PCs) either by digital rectal examination (DRE) or by prostate-specific antigen (PSA) as biopsy indication at low PSA. METHODS: Two populations with PSA between 2.0 and 3.9 ng/ml were studied. Group-1 was biopsied if DRE was suspicious (1st screening round, N = 1877). In group-2 all men were offered biopsy, regardless of DRE result (side-study in 2nd screening-round, N = 801). We compared cancer detection rates (CDRs) and tumor characteristics. RESULTS: In group-1 abnormal DRE prompted biopsy in 253 (13.5%) men (236 (93.3%) actually biopsied). Forty-nine PCs were detected, CDR 49/1877 = 2.6%. In group-2 we found 120 cancers in 666 (83.1%) men actually biopsied, CDR = 120/801 = 15.0%. Of all cancers detected, organ confinement (clinical T2) was found in 77.5% (group-1) and 96.6% (group-2; of which 99 T1c). Of all PCs 46.9% in group-1 and 15.0% in group-2 had biopsy Gleason score (GS) > or = 7. In the latter, 15.2% of T1cs were classified GS > or = 7. Considering only PCs with organ confinement or GS > or = 7 for each group, CDRs amounted to 2.0% versus 14.5% and 1.2% versus 2.3% for group-1 and group-2, respectively. CONCLUSIONS: PSA-based screening detected a considerable amount (15.2%) of potentially aggressive tumors as T1cs, but in addition large numbers of possibly insignificant cancers (T1c, GS = 6) were diagnosed. DRE seemed to detect more selectively high-grade cancers, but also missed many of these. Considering both populations and the need to detect aggressive but confined cancers, PSA as biopsy indication outperformed DRE at the price of more biopsies (13.5% vs. 100% if all would comply).

Aged↗
PubMed2006

Active surveillance for prostate cancers detected in three subsequent rounds of a screening trial: characteristics, PSA doubling times, and outcome.

OBJECTIVES: To study active surveillance as a management option for the important number of prostate cancer patients who would not have been diagnosed in the absence of screening. PATIENTS AND METHODS: We analyzed baseline characteristics and outcome parameters of all men on active surveillance who were screen-detected in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Recruitment and surveillance of men were not guided by a protocol but depended on individual decisions of patients and their physicians. RESULTS: Active surveillance was applied in 278 men detected by screening from 1993 to 2006. At diagnosis, their median age was 69.8 yr (25-75p; 66.1-72.8); median PSA 3.6 ng/ml (25-75p; 3.1-4.8), and the clinical stage was T1c in 220 (79.1%) and T2 in 58 (20.9%). During the follow-up of median 3.4 yr, 103 men (44.2%) had a PSA doubling time that was negative (ie, half-life) or longer than 10 yr. Men detected at rescreening were significantly more likely to be on active surveillance, and they had more beneficial characteristics. Deferred treatment was elected in 82 cases (29.0%). Overall survival was 89% after 8 yr; the cause-specific survival was 100%. CONCLUSIONS: This report shows a beneficial, although preliminary, outcome of screen-detected men managed on active surveillance. Men were more likely to be on active surveillance if the disease was detected at repeated screening. The report also shows that an important proportion of men have prolonged PSA doubling times, although the value of this parameter has not been established in untreated men.

Adult↗
PubMed2006

Biochemical progression rates in the screen arm compared to the control arm of the Rotterdam Section of the European Randomized Study of Screening for Prostate Cancer (ERSPC).

BACKGROUND: The European Randomized study of Screening for Prostate Cancer (ERSPC) investigates the feasibility of population-based screening. This report compares the preliminary outcome of cancers detected in the screen and the control arm of its Rotterdam section, by means of biochemical progression rates. METHODS: In the screen arm of this study (21,210 men), screening was applied according to well-established protocols, and a 4-year screen interval was chosen. Widely accepted biochemical progression-criteria were used to evaluate the diagnosed cancers over time. RESULTS: Although more cancers were detected in the screen than in the control arm (1,339 vs. 298, P < 0.001), their clinico-pathological features were more favorable. Furthermore, screened men had higher 5-year survival rates for biochemical progression after surgery (84.4% vs. 58.9% in controls), radiotherapy (71.0% vs. 58.0%), and endocrine therapy (40.5% vs. 16.3%). CONCLUSIONS: The higher biochemical progression-free survival can at least in part be explained by lead and length-time. How screening will effect the mortality remains unclear.

Aged↗
PubMed2006

Detection rates of high-grade prostate cancer during subsequent screening visits. Results of the European Randomized Screening Study for Prostate Cancer.

Screening for prostate cancer using prostate-specific antigen (PSA) tests has led to a stage and grade shift as compared to the pre-PSA era. Effectiveness of screening for prostate cancer should be manifested by a reduction in detection rate of aggressive cancers during subsequent screening. In 6 centers of the European Randomized Screening study for Prostate Cancer, a total of 58,710 men were tested for prostate cancer. Screening centers differed with regard to age-range, screening interval and biopsy indications. During the 2nd visit, the proportion of Gleason score 6 cancers increased from 62.5 to 75%, mainly at the expense of Gleason score 7 cancers. High-grade (Gleason score 8-10) cancer detection rates varied per screening center during the 1st visit from 5.1 to 41.1, and during the 2nd visit from 6.4 to 29.3/10,000 men. The overall detection rate of high-grade cancers showed a reduction during the 2nd visit from 26 to 12/10,000 men, an effect mainly attributable to the screening center with the highest cancer detection rate (i.e. 507/10,000 men). Variations in detection rates among screening centers related among others to biopsy compliance and age range.

Age Factors↗
PubMed2006

Management and survival of screen-detected prostate cancer patients who might have been suitable for active surveillance.

OBJECTIVE: Screening practices for prostate cancer have resulted in an increasing incidence of prostate cancers. Our knowledge about which prostate cancers are life threatening and which are not is limited. Thus, for ethical, medical, and economic reasons we need to define which patients can be managed by active surveillance. METHODS: From 1993 through 1999, men from the Rotterdam section of the European Randomized study of Screening for Prostate Cancer (ERSPC) were screened by two strict protocols, which were based on prostate-specific antigen (PSA), digital rectal examination, and transrectal ultrasound. For this study, men with criteria that reflect current active surveillance studies were selected: those with a biopsy Gleason score < or =3+3 in two or fewer cores, with a PSA density <0.2 and a maximum PSA-level of 15 ng/ml. Clinical stage had to be T1C or T2. RESULTS: Of the 1,014 prostate cancers detected in the prevalence screen, 293 men (28.9%) met the criteria for active surveillance. Their mean age was 65.7 and the mean PSA level was 4.8 ng/ml. Radical prostatectomy was elected by 136 men (46.4%), radiotherapy by 91 (31.1%), and watchful waiting by 64 (21.8%). The mean follow-up was 80.8 months. The eight-year prostate cancer-specific survival was 99.2%; the overall survival was 85.4%. Nineteen men who chose watchful waiting changed to definitive treatment during follow-up. CONCLUSION: Only three men died of prostate cancer, none of whom were on watchful waiting. Our observations provide preliminary validation of the arbitrary selection criteria for active surveillance.

Aged↗
PubMed2006

A comparison of first and repeat (four years later) prostate cancer screening in a randomized cohort of a symptomatic men aged 55-75 years using a biopsy indication of 3.0 ng/ml (results of ERSPC, Rotterdam).

BACKGROUND: The identification of predictors for prostate biopsy outcome at two screening rounds using a PSA>or=3.0 ng/ml as biopsy indication. MATERIALS AND METHODS: We compared predictors by means of descriptive statistics and logistic regression analysis in men (55-75 years) biopsied in either the 1st or 2nd screening round of ERSPC Rotterdam (interval 4 years). RESULTS: Positive predictors for biopsy outcome in both screening rounds were an increased PSA level in the absence of a previous negative biopsy (PrevNB), DRE and TRUS suspicious and a positive family history (PFH). A higher than median prostate volume was a consistent negative predictor. Having had a PrevNB at initial screening strongly reduced the chance of cancer detection at repeat screening and in addition canceled the predictive potential of PSA. CONCLUSION: If "detecting prostate cancer efficiently" were the aim, this study indicates that a "PSA only based biopsy threshold" may be replaced by another criterion incorporating, e.g., DRE, TRUS and prostate volume in men who were biopsied in the preceding 4 year interval.

Aged↗
PubMed2006

Screening for prostate cancer without digital rectal examination and transrectal ultrasound: results after four years in the European Randomized Study of Screening for Prostate Cancer (ERSPC), Rotterdam.

BACKGROUND: Omission of DRE/TRUS as biopsy indication results in fewer unnecessary biopsies, but may increase the risk of missing potentially aggressive prostate cancers (PCs). In 1997, the biopsy indication within the ERSPC was changed from a PSA cut-off of 4.0 ng/ml and/or abnormal DRE/TRUS (group-1) to solely a PSA cut-off of 3.0 ng/ml (group-2). We estimated the effect of omitting DRE/TRUS by comparing the results of a re-screening 4 years after initial screening to the original policy. METHODS: We compared rate and characteristics of detected PCs in the second round in men initially screened in group-1 (N=5,957) or group-2 (N=8,044). Additionally, we compared the rate of interval cancers (ICs) after screening with and without DRE/TRUS. RESULTS: There was no significant difference in second round cancer-detection-rates (group-1, 3.0%; group-2, 2.7%), positive-predictive-values (group-1, 23.9%; group-2, 26.3%), and number of poorly-differentiated tumors (group-1, 2.6%; group-2, 3.8%). Most PCs were clinically confined to the prostate. Eleven ICs were detected in each group (0.18 and 0.14%). CONCLUSIONS: Omitting DRE/TRUS did not result in an increased IC- or PC-detection. However, considering the natural history of PC, the 4-year follow-up may be too short to draw a definitive conclusion.

Follow-Up Studies↗
PubMed2006

Does PSA velocity predict prostate cancer in pre-screened populations?

UNLABELLED: PSA-driven screening has been applied to a large part of the male population in many countries. An elevated PSA in secondary screens may indicate benign enlargement of the prostate rather than prostate cancer. In such cases the yearly rate of increase of PSA (PSA velocity [PSAV]) may improve the test characteristics of PSA. MATERIALS AND METHODS: Data from the European Randomized Study of Screening for Prostate Cancer Rotterdam are used to study the issue. Relative sensitivity, relative specificity, and positive predictive value (PPV) are calculated. Logistic regression analysis is used to compare odds ratios for positive biopsies. The relationship between PSAV and parameters of tumour aggressiveness is investigated. RESULTS: Five hundred eighty-eight consecutive participants were identified who presented at their first screening with PSA values <4.0 and who progressed to PSA values >4.0 ng/ml four years later. None were biopsied in round one, all were biopsied in round two. Relative sensitivity and specificity depend strongly on PSAV cut-offs of 0.25-1.0 ng/ml/yr. The use of PSAV cut-offs does not improve the PPV of the PSA cut-off of 4.0 ng/ml, nor do any of the PSAV cut-offs improve the odds ratio for identifying prostate cancer with respect to the cut-off value of 4.0 ng/ml. The rate of aggressive cancers seems to increase with increasing PSAV. CONCLUSIONS: PSAV does not improve the detection characteristics of a PSA cut-off of 4.0 ng/ml in secondary screening after four years.

Aged↗
PubMed2006

Tumor characteristics and prognostic factors in two subsequent screening rounds with four-year interval within prostate cancer screening trial, ERSPC Rotterdam.

OBJECTIVES: To evaluate the tumor characteristics and prognostic factors in screen-detected prostate cancers in two successive screening rounds with a 4-year screening interval in the European Randomized Study of Screening for Prostate Cancer, section Rotterdam. METHODS: From 1993 to 2000, 42,376 men (21,210 in the screening arm and 21,166 in the control arm) were randomized and screened. Prostate-specific antigen testing, digital rectal examination, transrectal ultrasonography, and sextant biopsies were offered to the participants in the screening arm. A total of 1218 men with a biopsy indication at the first screening received an additional screening after 1 year (early recall). By 2004, all men had received their second screening. Interval carcinomas were defined as cancers detected during the screening interval and were identified by linkage with the Cancer Registry. RESULTS: In the first round, 1014 prostate cancers were detected--24 in the men noncompliant to screening, 63 at the early recall screening, and 433 in the second round of screening. Also, 62 interval carcinomas were diagnosed. In the second screening round, the mean prostate-specific antigen value was lower (5.6 versus 11.1 ng/mL), advanced clinical stage T3-T4 was 7.1-fold less common, and 76.4% versus 61.5% of the biopsy Gleason scores were less than 7. In the first screening round, 13 regional and 9 distant metastases were detected; in the second round, 2 cases with distant metastasis were found. CONCLUSIONS: Overall, a shift toward more favorable tumor characteristics was seen for the second round of screening. These results support the screening methods used and the interscreening interval of 4 years.

Aged↗
PubMed2006

Prevalence, treatment modalities and prognosis of familial prostate cancer in a screened population.

PURPOSE: A family history of prostate cancer is an important risk factor for this disease. The clinical presentation and prognosis of familial disease remain uncertain. In this study these entities are evaluated in the first and second rounds of a screening program in The Netherlands. MATERIALS AND METHODS: Of all men randomized in the Rotterdam section of the ERSPC, 19,970 men were eligible for screening. Information regarding the family history was obtained by a self-administered questionnaire at baseline. RESULTS: In the prevalence screen the cancer detection rate in 1,364 men (7.1%) with a positive family history was 7.7% (106 cancers in 1,364 screened men with a positive family history) while the positive predictive value of the biopsies was 32.2% (154 cancers of 532 biopsies). In 12,803 sporadic cases the detection rate was 4.7% and the positive predictive value was 23.6% (p <0.0001 and 0.003, RR 1.63). No clinicopathological differences were found in the 1,559 men diagnosed in the first and second rounds. The overall biochemical-free survival rate after a mean followup of 56.8 months (range 0 to 129.9) was 76.8%, and was not significantly different in familial and sporadic cases (p = 0.840). These findings were consistent for the specific treatment modalities as well. CONCLUSIONS: Although screened men 55 to 75 years old with a father or a brother having prostate cancer themselves are at a substantially greater risk for the disease, the clinical presentation, treatment modalities and prognosis by biochemical progression are not different compared to sporadic cases.

Aged↗
PubMed2005

Tumour features in the control and screening arm of a randomized trial of prostate cancer.

OBJECTIVE: To compare tumour characteristics at the time of diagnosis of cancers detected in the screening and control arm at the Rotterdam section of the European Randomized study of Screening for Prostate Cancer. METHODS: Data were retrieved from the Rotterdam section of the ERSPC. Men were randomized to the screening arm (n=21,210) or the control arm (n=21,166). Men randomized to screening were offered PSA testing every 4 years. Through linkage with the cancer registry, men randomized to the control arm were detected. The biopsy Gleason score was determined in 1,591 and 373 patients in the screening and control arm, respectively. TURP, radical prostatectomy (RP) and cystoprostatectomy were evaluated for Gleason score, pathological (p)T stage and tumour volume. RESULTS: More prostate cancers were detected in the screening arm (15.9 vs. 4.2 per 1000 man years, p<0.0001). Clinical stage distribution as well as biopsy and RP Gleason score distribution were significantly less favourable in the control arm. The incidence in man years of advanced disease (i.e. T4/N1/M1) was higher in the screening arm (6.0 per 100,000) as compared to the control arm (4.6 per 100,000). The 5-year PSA progression free survival after RP was 68% in the control arm and 89% in the screening arm (p<0.0001). The proportion of Incidental prostate cancers was 9.3% of all cancers detected in the control arm. CONCLUSIONS: Although the number of men with advanced prostate cancer is slightly higher in the screening arm, the proportion of prostate cancers with favourable features is increased in the screening arm as compared to that in the control arm.

Aged↗
PubMed2005

Randomized, double-blind, placebo-controlled crossover study in men with prostate cancer and rising PSA: effectiveness of a dietary supplement.

OBJECTIVES: Epidemiological studies have shown significant relationships between the use of dietary components and prostate cancer incidence and mortality. Large studies of primary prevention, which confirm these findings, are desirable but costly and difficult to design. The present tertiary prevention study reports on the effect of a dietary supplement in comparison with placebo on the rate of increase of prostate-specific antigen (PSA). METHODS: 49 patients with a history of prostate cancer and rising PSA levels after radical prostatectomy (n = 34) or radiotherapy (n = 15) participated in a randomised, double-blind, placebo-controlled crossover study of a dietary supplement. Ethical approval of the protocol was obtained. Treatment periods of 10 weeks were separated by a 4-week washout period. The supplement consisted of soy, isoflavones, lycopene, silymarin and antioxidants as main ingredients. Changes in the rate of increase of PSA (PSA slope and doubling time) were the primary parameters of efficacy. Analyses according to intention to treat (ITT) and per protocol (PP) were carried out. RESULTS: Baseline parameters did not differ between randomised groups. Five participants were lost to follow-up, however 46 could be evaluated in an ITT analysis. PP analysis could be performed in 42 men with at least 5 PSA measurements. Per protocol analysis showed a significant decrease in PSA slope (p = 0.030) and (2)log PSA slope (p = 0.041). This translates into a 2.6 fold increase in the PSA doubling time from 445 to 1150 days for the supplement and placebo periods. No treatment-based changes in safety parameters were observed during the study. CONCLUSIONS: The soy-based dietary supplement utilised in this study was shown to delay PSA progression after potentially curative treatment in a significant fashion. More extensive studies of the supplement may be indicated.

Adult↗
PubMed2005

Incidence and follow-up of patients with focal prostate carcinoma in 2 screening rounds after an interval of 4 years.

BACKGROUND: Focal carcinoma detected by needle biopsy has been a common finding since prostate-specific antigen (PSA)-based screening was introduced. Clinicopathologic features in patients with focal prostate carcinoma who underwent radical prostatectomy (RP) or who were treated with watchful waiting (WW) were analyzed to detect clinical predictors for disease progression during follow-up. METHODS: Patients were selected from the European Randomized Screening study for Prostate Cancer. Focal carcinoma on sextant biopsy was defined as <or=3.0 mm involvement by tumor in 1 biopsy core lacking Gleason pattern 4 or 5. PSA doubling time was used in the WW group as a marker of disease progression. RESULTS: The proportion of patients with focal prostate carcinoma increased significantly from 16% in the first screening round to 29% in the second screening round. One hundred eighteen men underwent RP, and 108 men were treated with WW. The median tumor volume was 0.13 mL. PSA level and prostate volume were predictive for tumor volume in a multivariate regression analysis. A PSA density cut-off level of <or=0.1 ng/mL/cm3 predicted organ-confined tumor (<0.5 mL) in 94% of patients. Positive surgical margins were predictive for PSA recurrence. Four patients in the RP group had PSA recurrence at follow-up. PSA doubling times <2 years, <3 years, and <4 years were noted in 4.9%, 14.6%, and 22.0% of patients in the WW group, respectively. CONCLUSIONS: The median tumor volume was small (0.13 mL). A comparison between PSA recurrence in the RP group and PSA doubling time in the WW group showed a significantly more favorable outcome after RP if a PSA doubling time of <3 years or <4 years was chosen as a marker for disease progression in the WW group. A WW policy with delayed curative intent may be recommended in patients ages 55-75 years with focal carcinoma and PSA density <0.1 ng/mL/cm3.

Aged↗
PubMed2005

Is additional testing necessary in men with prostate-specific antigen levels of 1.0 ng/mL or less in a population-based screening setting? (ERSPC, section Rotterdam).

OBJECTIVES: Currently, several prostate cancer rescreening intervals are in use in different countries worldwide, varying from 1 to 4 years. Recently, it has been proposed to determine the rescreening interval relative to the initial prostate-specific antigen (PSA) level and possibly to extend the rescreening interval up to 5 years. METHODS: We evaluated the screening results of two subsequent screening visits (4-year interval) of 1703 men aged 55 to 65 years with an initial PSA level of 1.0 ng/mL or less within a randomized screening trial. We assessed the PSA values, numbers of men biopsied (biopsy indication: PSA level of 3.0 ng/mL or greater), and numbers of cancers detected at the second and third screening visits. RESULTS: A total of 1327 men (79.3%) attended the second screening visit. Of these men, 13 (0.98%) had a PSA level of 3.0 ng/mL or greater, and three cancers were detected (cancer detection rate 0.23%). At the third screening visit, 1017 men (76.8%) attended, 34 men (3.3%) had a PSA level of 3.0 ng/mL or greater, and five cancers were detected (cancer detection rate 0.49%). The 2344 subsequent PSA determinations in an 8-year period after the initial screening resulted in eight cancers detected, for an overall cancer detection rate of 0.47%. Through linkage of all men with the cancer registry, no additional cancers were found. CONCLUSIONS: A strategy of PSA screening every 8 years for men with a PSA level of 1.0 ng/mL or less will lead to a considerable decrease in the number of screening visits (with the associated costs and stress), with a minimal risk of missing aggressive cancer at a curable stage.

Adenocarcinoma↗
PubMed2005

Comparison of screen detected and clinically diagnosed prostate cancer in the European randomized study of screening for prostate cancer, section rotterdam.

PURPOSE: This report provides a comparison of characteristics detected in the screening and control arms of the European Randomized study of Screening for Prostate Cancer, section Rotterdam. MATERIALS AND METHODS: Between December 1993 and January 1999, 35,148 men 55 to 74 years old were randomized to European Randomized study of Screening for Prostate Cancer Rotterdam, including 17,635 in the screening arm and 17,513 in the control arm. Prostate specific antigen testing, digital rectal examination, transrectal ultrasound and sextant biopsies were offered to all participants in the screening arm according to 2 algorithms. All screening detected cancers and cancers found in the control arm were evaluated at the same cutoff point, that is January 1, 2003. To identify prostate cancer cases in the control arm yearly linkage was performed with the Rotterdam Cancer Registry database. Followup information was collected by chart review. RESULTS: By January 1, 2003, 1,269 cancers were detected in the screening arm and 336 were detected in the control arm. A shift to more favorable clinical stages and histological grades on biopsy was seen in the screening arm of the trial. T1C and T2 cancers were 5.8 and 6.2 times more often diagnosed, respectively, in the screening arm than in the control arm of the trial. Only 4.6% of control arm cancers were found through opportunistic screening. CONCLUSIONS: Although a favorable shift in prognostic factors was seen for the screening arm of the trial, these results do not provide evidence that prostate cancer screening has an effect on prostate cancer mortality.

Aged↗
PubMed2005

4-year prostate specific antigen progression and diagnosis of prostate cancer in the European Randomized Study of Screening for Prostate Cancer, section Rotterdam.

PURPOSE: The European Randomized Study of Screening for Prostate Cancer investigates the impact of screening on prostate cancer mortality and contributes to a better understanding of available screening tests. The present study evaluates the predictive value of a prostate specific antigen (PSA) increase to PSA 3.0 ng/ml or greater in a 4-year period in men who present with low PSA values (less than 3.0 ng/ml) at first screen. MATERIALS AND METHODS: A total of 42,376 men were randomized to screening vs control in Rotterdam. Of 6,467 men 5,771 had PSA values of less than 3.0 ng/ml, did not undergo biopsy at baseline and were rescreened after 4 years with PSA 3.0 ng/ml or greater as biopsy indication. PSA progression in a 4-year interscreening interval is evaluated by determining the positive predictive values, detection rates and parameters of aggressiveness of round 2 cancers. RESULTS: PSA progression to more than 3.0 ng/ml occurred in 0.9%, 9.3% and 48.6% of men who presented with PSA values less than 1.0, 1 to 1.9 and 2 to 2.9 ng/ml, respectively, in round 1. Their respective positive predictive values amounted to 19.0%, 23.8% and 27.9%. Cancer detection rates increased with increasing PSA values in round 1. The distribution of low, moderate and high risk cancers depends on round 2 but not on round 1 PSA ranges. CONCLUSIONS: PSA progression to the (arbitrary) cutoff value of 3.0 ng/ml and the diagnosis of prostate cancer in round 2 screening with a 4-year interval depends strongly on PSA values at the time of the 1st screen. These observations will be helpful to design future screening procedures. With levels less than 2.0 ng/ml PSA progression to levels of 3.0 ng/ml or greater is rare as it was seen only in 4.8% of all men.

Humans↗