scholarly journals Finasteride to Prevent Prostate Cancer: Should All Men or Only a High-Risk Subgroup Be Treated?

2010 ◽  
Vol 28 (7) ◽  
pp. 1112-1116 ◽  
Author(s):  
Andrew J. Vickers ◽  
Caroline J. Savage ◽  
Hans Lilja
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Specific Antigen ◽  
Treatment Strategies ◽  
Routine Care ◽  
Treatment Rate ◽  
Cancer Rate ◽  
Prostate Cancer Prevention ◽  
Numbers Needed To Treat ◽  
Treat All

Purpose Finasteride has been shown to reduce the incidence of prostate cancer. Yet the use of finasteride remains low, likely because of the risk of adverse effects. We sought to determine whether prostate-specific antigen (PSA) levels could identify a high-risk subgroup for which the benefits of finasteride treatment outweigh the potential harms. Patients and Methods Raw data from the Prostate Cancer Prevention Trial were used to model chemopreventive treatment strategies: treat all men, treat no men, or treat a high-risk subgroup based on PSA level. We weighted the benefits (reduction in cancer rate) and harms (treatment rate) of each strategy using numbers-needed-to-treat thresholds—the maximum number of men a clinician would treat with finasteride to prevent one cancer. Results Of 9,058 men, 1,957 were diagnosed with prostate cancer during the 7-year study. For the end point of all cancers, including both for-cause and end-of-study biopsies, the optimal strategy is to treat all or nearly all men. To reduce risk of cancers detected through routine care, treating men with PSA > 1.3 or > 2 ng/mL is optimal. For example, treating only men with PSA > 2 ng/mL reduced the treatment rate by 83% and resulted in a cancer rate only 1.1% higher than treating all men. Conclusion Clinicians wishing to reduce the risk of any biopsy-detectable prostate cancer should recommend finasteride to all men. Clinicians who believe that it is unnecessary to prevent all cancers, but that preventing those readily detectable by screening would be desirable, would be best off recommending finasteride only to a high-risk subgroup.

scholarly journals Screening for prostate cancer: How to manage in 2006

2005 ◽  
Vol 52 (4) ◽  
pp. 19-21 ◽  
Author(s):  
B. Lobel
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Prostate Biopsy ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Rectal Biopsy ◽  
High Risk Population ◽  
Major Question ◽  
Prostate Cancer Prevention ◽  
History Of

National Societies usually recommend screening for Prostate Cancer (PC) with Serum Prostate Specific Antigen (PSA) and digital rectal examination annually beginning at age 50. In high risk population including men with a family history of PC or African population screening should start at age of 45 years. PSA has been widely used to detect PC despite the fact that PSA is not specific for PC. Over the years serum PSA level of greater than 4,0ng/ml was considered the threshold to perform prostate biopsy, searching for PC. In 2005 the Prostate Cancer Prevention Trial (PCPT) demonstrated that the cut-off of 4,0ng/ml for PSA is not anymore adapted1 due to the fact that this survey found in 15% of men with PSA < or = 4,0ng/ml a prostate cancer on sextant biopsies. Today the value of PSA and the cut-off for Prostate biopsy is questioned suggesting that PSA level higher than 2,6ng/ml must be the case to propose Prostate Biopsy. Catalona confirms that approximately 25% to 30% of men with PSA 2,6 to 4,0ng/ml have prostate cancer2. Schr?der and Gosselaar3 assert that screening for PC at low PSA levels (<4,0ng/ml) risks to detect clinically insignificant cancers which are no threat to man. So far in the year 2006 screening for PC demonstrates accumulating evidences of efficacy but persistent uncertainty4. The major question for an urologist at work when facing a young men searching early diagnosis of PC is: at which level of PSA do we have to perform rectal biopsy ?.

A Genetic Score Can Identify Men at High Risk for Prostate Cancer Among Men With Prostate-Specific Antigen of 1–3 ng/ml

2014 ◽  
Vol 65 (6) ◽  
pp. 1184-1190 ◽  
Author(s):  
Tobias Nordström ◽  
Markus Aly ◽  
Martin Eklund ◽  
Lars Egevad ◽  
Henrik Grönberg
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Prostate Specific Antigen ◽  
Specific Antigen ◽  
Genetic Score

The national impact of the COVID-19 pandemic on U.S. prostate cancer community care.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5061-5061
Author(s):  
Matthew R. Cooperberg ◽  
Paul Brendel ◽  
Daniel J. Lee ◽  
Rahul Doraiswami ◽  
Hariesh Rajasekar ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Language Processing ◽  
Care Delivery ◽  
Specific Antigen ◽  
Risk Groups ◽  
Low Risk ◽  
T Stage ◽  
Risk Stratum ◽  
The Impact

5061 Background: We used data from a specialty-wide, community-based urology registry to determine trends in outpatient prostate cancer (PCa) care during the COVID-19 pandemic. Methods: 3,165 (̃ 25%) of US urology providers, representing 48 states and territories, participate in the American Urological Association Quality (AQUA) Registry, which collects data via automated extraction from electronic health record systems. We analyzed trends in PCa care delivery from 156 practices contributing data in 2019 and 2020. Risk stratification was based on prostate-specific antigen (PSA) at diagnosis, biopsy Gleason, and clinical T-stage, and we used a natural language processing algorithm to determine Gleason and T-stage from unstructured clinical notes. The primary outcome was mean weekly visit volume by PCa patients per practice (visits defined as all MD and mid-level visits, telehealth and face-to-face), and we compared each week in 2020 through week 44 (November 1) to the corresponding week in 2019. Results: There were 267,691 PCa patients in AQUA who received care between 2019 and 2020. From mid-March to early November, 2020 (week 10 – week 44) the magnitude of the decline and recovery varied by risk stratum, with the steepest drops for low-risk PCa (Table). For 2020, overall mean visits per day (averaged weekly) were similar to 2019 for the first 9 weeks (̃25). Visits declined to week 14 (18.19; a 31% drop from 2019), recovered to 2019 levels by week 23, and declined steadily to 11.89 (a 58% drop from 2019) as of week 44, the cut off of this analysis. Conclusions: Access to care for men with PCa was sharply curtailed by the COVID-19 pandemic, and while the impact was less for men with high-risk disease compared to those with low-risk disease, visits even for high-risk individuals were down nearly one-third and continued to fall through November. This study provides real-world evidence on the magnitude of decline in PCa care across risk groups. The impact of this decline on cancer outcomes should be followed closely.[Table: see text]

scholarly journals A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e046588
Author(s):  
Stephen J Freedland ◽  
Ugo De Giorgi ◽  
Martin Gleave ◽  
Brad Rosbrook ◽  
Qi Shen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Specific Antigen ◽  
Local Therapy ◽  
Standard Of Care ◽  
Open Label ◽  
Phase 3 ◽  
Double Blind ◽  
Randomised Study ◽  
Definitive Therapy

IntroductionLimited data from controlled clinical trials are available for men who experience biochemical recurrence after definitive therapy for prostate cancer. In the absence of overt metastases, patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) often receive androgen deprivation therapy (ADT). There is no standard-of-care consensus on optimal ADT timing, although most men are treated prior to metastases, especially those with high-risk features (Gleason score 8–10 or prostate-specific antigen doubling time (PSADT) <9–12 months). Given data that ADT plus novel hormonal agents improve survival in men with metastatic CSPC, there is a desire to evaluate these agents earlier in the disease course. The main objective of EMBARK is the comparative assessment of enzalutamide plus leuprolide (luteinising hormone-releasing hormone agonist (LHRHa)) or enzalutamide monotherapy versus monotherapy LHRHa to improve metastasis-free survival (MFS) in patients with high-risk nmCSPC PSA recurrence after definitive therapy.Methods and analysisEMBARK is a randomised, phase 3 study of high-risk patients with nmCSPC, a PSADT of ≤9 months and a screening PSA of ≥2 ng/mL above the nadir after radiotherapy (RT) or ≥1 ng/mL after radical prostatectomy (RP) with or without postoperative RT. Men (n=1050) are randomised 1:1:1 to enzalutamide 160 mg/day plus LHRHa or placebo plus LHRHa (double-blind arms) or enzalutamide monotherapy (open-label arm). Treatment is suspended at week 37 if PSA concentrations are <0.2 ng/mL and reinstated if levels rise to ≥2.0 ng/mL with RP or ≥5.0 ng/mL without RP. Patients with PSA ≥0.2 ng/mL at week 37 continue until treatment discontinuation criteria are met. The primary endpoint is MFS comparing enzalutamide plus LHRHa versus placebo plus LHRHa.Ethics and disseminationThe study is conducted under the guiding principles of the World Medical Association Declaration of Helsinki. The results will be disseminated at research conferences and in peer-reviewed journals.Trial registration numberNCT02319837.

The Influence of Finasteride on the Development of Prostate Cancer

2021 ◽  
pp. 7-12
Author(s):  
Niranjan Sathianathen
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Oncological Outcomes ◽  
Prostate Cancer Prevention ◽  
Secondary Analyses ◽  
High Risk Cancer ◽  
Medicare Claims Data ◽  
Major Reduction ◽  
Disease Specific

This chapter describes the design, main findings, relevance, and limitations of the landmark Prostate Cancer Prevention Trial (PCPT), which randomized men to finasteride versus placebo and followed them for 7 years. It found a major reduction in prostate cancer incidence but also a higher proportion of high-risk cancer in men diagnosed with prostate cancer. The study did not address the more important oncological outcomes of disease-specific and overall survival. Secondary analyses of PCPT outcomes favored the finasteride arm and suggested that the risk of high-risk cancer is not increased. Linkage analysis of participants from PCPT to Medicare claims data suggested no adverse long-term cardiac, endocrine, or sexual effects.

scholarly journals Circulating mRNA signature as a marker for high-risk prostate cancer

2019 ◽  
Vol 41 (2) ◽  
pp. 139-145
Author(s):  
Marilesia Ferreira De Souza ◽  
Hellen Kuasne ◽  
Mateus De Camargo Barros-Filho ◽  
Heloísa Lizotti Cilião ◽  
Fabio Albuquerque Marchi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Specific Antigen ◽  
Treatment Decision ◽  
Tumor Stage ◽  
Aggressive Disease ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
Invasive Method ◽  
Biopsy Gleason Score

Abstract Prostate cancer (PCa) is the second most common cancer in men. The indolent course of the disease makes the treatment choice a challenge for physicians and patients. In this study, a minimally invasive method was used to evaluate the potential of molecular markers in identifying patients with aggressive disease. Cell-free plasma samples from 60 PCa patients collected before radical prostatectomy were used to evaluate the levels of expression of eight genes (AMACR, BCL2, NKX3-1, GOLM1, OR51E2, PCA3, SIM2 and TRPM8) by quantitative real-time PCR. Overexpression of AMACR, GOLM1, TRPM8 and NKX3-1 genes was significantly associated with aggressive disease characteristics, including extracapsular extension, tumor stage and vesicular seminal invasion. A trio of genes (GOLM1, NKX3-1 and TRPM8) was able to identify high-risk PCa cases (85% of sensitivity and 58% of specificity), yielding a better overall performance compared with the biopsy Gleason score and prostate-specific antigen, routinely used in the clinical practice. Although more studies are required, these circulating markers have the potential to be used as an additional test to improve the diagnosis and treatment decision of high-risk PCa patients.

scholarly journals Phase III Intergroup Trial of Adjuvant Androgen Deprivation With or Without Mitoxantrone Plus Prednisone in Patients With High-Risk Prostate Cancer After Radical Prostatectomy: SWOG S9921

2018 ◽  
Vol 36 (15) ◽  
pp. 1498-1504 ◽  
Author(s):  
Maha Hussain ◽  
Catherine M. Tangen ◽  
Ian M. Thompson ◽  
Gregory P. Swanson ◽  
David P. Wood ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Specific Antigen ◽  
Androgen Deprivation ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Adjuvant Radiation ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer

Purpose Patients with high-risk prostate cancer after radical prostatectomy are at risk for death. Adjuvant androgen-deprivation therapy (ADT) may reduce this risk. We hypothesized that the addition of mitoxantrone and prednisone (MP) to adjuvant ADT could reduce mortality compared with adjuvant ADT alone. Methods Eligible patients had cT1-3N0 prostate cancer with one or more high-risk factors after radical prostatectomy (Gleason score [GS] ≥ 8; pT3b, pT4, or pN+ disease; GS 7 and positive margins; or preoperative prostate-specific antigen [PSA] > 15 ng/mL, biopsy GS score > 7, or PSA > 10 ng/mL plus biopsy GS > 6. Patients with PSA ≤ 0.2 ng/mL after radical prostatectomy were stratified by pT/N stage, GS, and adjuvant radiation plan and randomly assigned to ADT (bicalutamide and goserelin for 2 years) or ADT plus six cycles of MP. The primary end point was overall survival (OS). Median OS was projected to be 10 years in the ADT arm, requiring 680 patients per arm to detect a hazard ratio of 1.30 with 92% power and one-sided α = .05. Results Nine hundred sixty-one eligible intent-to-treat patients were randomly assigned to ADT or ADT + MP from October 1999 to January 2007, when the Data Safety Monitoring Committee recommended stopping accrual as a result of higher leukemia incidence with ADT + MP. Median follow-up was 11.2 years. The 10-year OS estimates were 87% with ADT (expected 50%) and 86% with ADT + MP (hazard ratio, 1.06; 95% CI, 0.79 to 1.43). The 10-year estimate for disease-free survival was 72% for both arms. Prostate cancer was the cause of death in 18% of patients in the ADT arm and 22% in the ADT + MP arm. More patients in the MP arm died of other cancers (36% v 18% in ADT alone arm). Conclusion MP did not improve OS and increased deaths from other malignancies. The DFS and 10-year OS in these patients treated with 2 years of ADT were encouraging compared with historical estimates, although a definitive conclusion regarding value of ADT may not be made without a nontreatment control arm.

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