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- Gronberg, H, et al.
(författare)
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The risk-based STHLM3 model to improve prostate cancer testing in men 50-69 years: Further health, economic, and clinic evaluation
- 2016
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Ingår i: JOURNAL OF CLINICAL ONCOLOGY. - : American Society of Clinical Oncology (ASCO). - 0732-183X .- 1527-7755. ; 34:2
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- 36 Background: Prostate-specific antigen (PSA) is used to screen for prostate cancer but suffers from a high false-positive rate that translates into unnecessary prostate biopsies and over-diagnosis of low-risk prostate cancers. We aimed to develop a model for prostate cancer screening with better test characteristics than PSA. Methods: STHLM3 is a prospective, population-based, paired screen-positive diagnostic study. It investigates whether the predefined STHLM3 model, a combination of 6 plasma protein biomarkers (PSA, free-PSA, intact-PSA, HK2, MIC-1, and MSMB), genetic polymorphisms (232 SNPs), and clinical variables (age, family history, previous biopsies, DRE, and prostate volume) can substantially reduce the proportion of men biopsied while maintaining the same sensitivity to diagnose Gleason score ≥ 7 prostate cancer as PSA ≥3 ng/ml. In addition, a health economic evaluation was performed comparing the STHLM3 model with current clinical practice in Stockholm. Results: 58,818 men without prostate cancer aged 50-69, participated in the STHLM3 study, with 6,700 undergoing subsequent prostate biopsy. The STHLM3 model performed significantly better (p<0.001) than PSA for detecting GS ≥7 cancers, increasing the Area Under the Curve from 0.56 to 0.74. All variables used in the STHLM3 Model were significantly associated with Gleason score ≥7 prostate cancers (p<0.05) in a multiple logistic regression model. Using the same sensitivity as PSA ≥3 ng/ml to diagnose Gleason score ≥7 prostate cancer, the STHLM3 model reduced the number of biopsies by 32% (95% CI 24%-39%) and avoided 44% (95% CI; 35%-54%) of the negative biopsies. The number of Gleason score 6 cancers was reduced by 17% (95% CI; 7%-26%). Positive ICER for the STHLM3 model was seen in all models of the health economic analysis. Conclusions: The STHLM3 model reduces unnecessary biopsies without compromising the ability to diagnose Gleason score ≥7 prostate cancer in a cost-efficient way. This is a significant step towards personalized risk-based prostate cancer diagnostic programs. Clinical trial information: ISRCTN84445406.
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| 3. |
- Nordstrom, T, et al.
(författare)
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Association of changing prostate-specific antigen (PSA) levels on repeat testing with lower risk for Gleason Score (GS) >= 7 prostate cancer
- 2016
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Ingår i: JOURNAL OF CLINICAL ONCOLOGY. - : American Society of Clinical Oncology (ASCO). - 0732-183X .- 1527-7755. ; 34:2
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- 284 Background: PSA levels are often verified before recommending a prostate biopsy because of the variability of PSA, We used data from the STHLM3 trial to assess the value of a second PSA test taken prior to biopsy. Methods: STHLM3 is a prospective and population-based prostate cancer diagnostic study performed in Stockholm, Sweden, 2013-2015. 1686 men in STHLM3 with a PSA value 3-10 ng/ml performed a second PSA test within 8 weeks of the first test and then underwent prostate biopsy. We compared proportions of cancer detected in men with stable PSA levels (2nd PSA within +/-10% of 1stPSA) to men whose PSA levels increased or decreased at least 10%, respectively. Results: Men with GS ≥ 7 cancer in the biopsy had more stable PSA than men with benign biopsies; the median change was 13.7% (inter-quartile range (IQR) 6.1-26.9) in men with benign biopsies, 13.0% (IQR 6.1-25.6) in men with GS ≤ 6 tumors and 8.2% (IQR 4.5-16.7) in men with GS ≥ 7 tumors. The average risk of having GS ≥ 7 cancer was 15.4% (95% CI 13.7 – 17.1) after the first test (i.e. the entire cohort), 21.6% (95% CI 18.6 – 24.6) in men with stable PSA levels compared with 13.5% (95% CI 10.2 – 16.7) and 9.0% (95% CI 6.6 – 11.4) if PSA levels increased or decreased at least 10%, respectively. There were no significant differences in risk of GS ≤ 6 tumor for men with stable PSA compared to men with increasing/decreasing PSA. Conclusions: As previously shown, the risk of prostate cancer decreases if a repeat PSA test shows decreasing levels. We show that this effect mainly affect GS ≥ 7 tumors, and that the risk of prostate cancer also decreases with increasing PSA values. Our findings need validation, but suggest that PSA is more stable in men with GS ≥ 7 cancer, whereas elevated but fluctuating PSA levels to a higher degree are caused by other processes (e.g. inflammation). Use of decision tools could aid incorporation of complex information such as repeat PSA values in diagnostics.
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- Van Hemelrijck, M, et al.
(författare)
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Mortality following hip fractures in men with prostate cancer
- 2013
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Ingår i: JOURNAL OF CLINICAL ONCOLOGY. - : American Society of Clinical Oncology (ASCO). - 0732-183X .- 1527-7755. ; 31:6
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- 49 Background: Rapid loss of bone-mineral density is a known side-effect of androgen deprivation therapy (ADT) for prostate cancer (PCa). Hip fractures are also independently associated with risk of mortality. To our knowledge few population-based observational studies have yet investigated the risk of dying following fractures among men with PCa. We aimed to assess skeletal-related events and mortality in more detail by specifically studying the link between hip fractures in PCa men and risk of death. Methods: PCBaSe Sweden 2.0 is based on the National Prostate Cancer Register and contains age and county matched men free of PCa. We selected all men (n=14,205) who had been hospitalized with a hip fracture, as registered in the National Patient Register, between 2006 and 2010. A total of 2300 were diagnosed with PCa before the hip fracture and 66% of them were treated with ADT. The main outcome was death as registered in the National Cause of Death Register. The risk of death was estimated using multivariate Cox Proportional Hazards regression analyses and standardized mortality ratios (SMRs) taking into account PCa risk category, history of fractures, civil status, Charlson Comorbidity Index, and treatment with bisphosphonates. Results: In the analysis for risk of death >90 days after a hip fracture, there was an increased risk of death among PCa men on ADT, especially those aged <84 years (e.g., HR at 3-6 months after hip fracture: 2.47 (95%CI: 1.85-3.30) compared to men free of PCa with a hip fracture). The SMRs showed that PCa men on ADT who got a hip fracture were seven times more likely to die than expected in the reference population of all men with PCa, whereas PCa men who were not on ADT and had a hip fracture were 13 times more likely to die than expected in this reference population. However, the absolute risk difference between men with and without a hip fracture was 30 per 1,000 person-years when evaluating the effect of a hip fracturing among men on ADT, whereas a hip fracture would cause an additional 20 per 1,000 person-years to die among PCa men without ADT as well as among men free of PCa. Conclusions: Our SMRs and absolute risk calculations show that hip fractures are more dangerous in PCa men treated with ADT than in PCa men without ADT or in men free of PCa.
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