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Thread: PSA: Standard vs Ultrasensitive The Pros and Cons

  1. #1

    Post PSA: Standard vs Ultrasensitive The Pros and Cons

    ​There is a great deal of controversy lately regarding the humble PSA blood test which, as prostate cancer patients, we are frequently exposed to.
    The intent of this thread is not intended to promote or defend my personal view which appears to be somewhat unpopular but simply to provide a growing collection of recent, scholarly information, provided by myself and others reflecting both sides.

    Content must meet 3 simple criteria.

    (1) Articles must come from credible, verifiable sources e.g Accredited teaching institutions, US Government sources, Wikipedia w/citations etc.

    (2) Either links or full text may be used. If full text, be sure to acknowledge the author/s and respect copyright law.

    (3) You may not alter the original content for any reason and keep in mind that this is NOT a debate thread. It exists solely to compare the merits of the tests. Personal views are not acceptable content unless you are a licensed, practicing professional currently working in this field. Your full name, license #, and state where you are licensed will be required.

  2. #2

    Ultrasensitive PSA Tests: Can They Be Helpful After Surgery?

    The Patrick C. Walsh Prostate Cancer Research Fund Ultrasensitive PSA Tests: Can They Be Helpful After Surgery?

    After radical prostatectomy, a man’s levels of PSA in the blood are supposed to be undetectable, and for most men, this is what happens. If, months or years after surgery, PSA becomes detectable – above 0.1 ng/ml – and there are no other signs that the cancer has returned, this is called “biochemical recurrence.” “Clinical laboratories can confidently measure PSA at those levels,” says Lori Sokoll, Ph.D., the Prostate Cancer Team Scholar. “However, there are ultrasensitive assays that can detect very minute levels of PSA .” Use of these ultrasensitive tests has been controversial. Some scientists have proposed that with these ultrasensitive PSA assays, men who have PSA levels below a specific cutoff point shortly after surgery could have extra reassurance that their cancer is gone for good, and that men with PSA levels above this point might be monitored more closely. Other scientists and doctors believe that these lower levels may just make men anxious when they don’t need to be.

    In a preliminary study, Sokoll, with coinvestigators Adam Reese, Daniel Chan, Zhen Zhang, and Alan Partin, used an ultrasensitive assay to measure PSA in men after radical prostatectomy who either had biochemical recurrence or were free of recurrence for at least five years. The ultrasensitive test was able to pick up PSA at higher levels in the recurrence group compared to the men whose cancer did not return. The assay was also able to predict which men would likely be free of biochemical recurrence at five years after surgery.

    Next, Sokoll and colleagues are seeking to confirm these results in a larger study and to determine whether another ultrasensitive assay used in the Johns Hopkins Clinical Chemistry Laboratory will have a similar performance. “We hope that this study will help to establish whether there is benefit to using ultrasensitive PSA assays in men after surgery to predict their long-term likelihood of remaining cancer-free.”

    © The Johns Hopkins University, The Johns Hopkins Hospital, and Johns Hopkins Health System. All rights reserved.

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    © The Johns Hopkins University, The Johns Hopkins Hospital, and Johns Hopkins Health System. All r ights reserved.

    © The Johns Hop

    Last edited by FeatherBoy; 05-09-2017 at 07:18 PM. Reason: Forgot to include copyright.

  3. #3

    Post Usefulness of ultra-sensitive prostate-specific antigen following radical surgery.

  4. #4

    Post Poor agreement of prostate specific antigen doubling times.

    J Urol. 2011 Dec;186(6):2228-32. doi: 10.1016/j.juro.2011.07.119. Epub 2011 Oct 19.
    Poor agreement of prostate specific antigen doubling times calculated using ultrasensitive versus standard prostate specific antigen values: important impact on risk assessment.

    Reese AC1, Fradet V, Whitson JM, Davis CB, Carroll PR.
    Author information



    In men with biochemical recurrence after radical prostatectomy, a rapid prostate specific antigen doubling time is associated with adverse outcomes, and is often used to guide the type and timing of salvage therapy. It is unknown whether prostate specific antigen doubling time calculated in the ultrasensitive range (prostate specific antigen less than 0.2 ng/ml) accurately reflects measures performed in the traditional range (prostate specific antigen greater than 0.2 ng/ml).

    We studied 394 men in a national disease registry of men with prostate cancer (CaPSURE™) who underwent radical prostatectomy, experienced biochemical failure, and had prostate specific antigen doubling time assessed using ultrasensitive and traditional prostate specific antigen values. Agreement between these measurements was assessed using Cohen's kappa score.

    Median ultrasensitive prostate specific antigen doubling time was 11.9 months (IQR 6-29) and median traditional prostate specific antigen doubling time was 240 months (IQR 18-240). Agreement between ultrasensitive and traditional prostate specific antigen doubling time was poor, with a weighted Cohen's kappa score of 0.04 (95% CI -0.02-0.10). Using a dichotomous prostate specific antigen doubling time cutoff of 9 months, there was a statistically significant difference between ultrasensitive and standard prostate specific antigen doubling time (exact McNemar p <0.01). Ultrasensitive prostate specific antigen doubling time was more or less rapid than traditional prostate specific antigen doubling time by more than 15 months in 244 (62%) and 35 (9%) patients, respectively.

    Agreement between prostate specific antigen doubling time calculated using ultrasensitive vs traditional prostate specific antigen values is poor. Ultrasensitive prostate specific antigen doubling time is often significantly more rapid than traditional prostate specific antigen doubling time, potentially overestimating the risk of clinical recurrence. Until the significance of ultrasensitive prostate specific antigen doubling time is better characterized, the decision to proceed with salvage therapy should not be based on prostate specific antigen doubling time calculated using ultrasensitive prostate specific antigen values.
    Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

    PMID: 22014796 DOI: 10.1016/j.juro.2011.07.119
    [Indexed for MEDLINE]
    Last edited by FeatherBoy; 05-09-2017 at 07:16 PM.

  5. #5


    *Post deleted per forum policy.
    Last edited by FeatherBoy; 05-09-2017 at 07:35 PM. Reason: Post Deletion

  6. #6
    Moderator Top User HighlanderCFH's Avatar
    Join Date
    Nov 2011
    FeatherBoy, the admin might ask you to remove the link to the other prostate cancer forum because linking to competing forums is against the rules of this site.

    July 2011 local PSA lab reading 6.41 (from 4.1 in 2009). Mayo Clinic PSA 9/ 2011 = 5.7.
    Local uro DRE revealed significant BPH, no lumps.
    PCa Dx Aug. 2011 age of 61.
    Biopsy DXd adenocarcinoma in 3/20 cores (one 5%, two 20%). T2C.
    Gleason 3+3=6. CT abdomen, bone scan negative.
    DaVinci prostatectomy 11/1/11 at Mayo Clinic (Rochester, MN), nerve sparing, age 62.
    Surgeon was Dr. Matthew Tollefson, who I highly recommend.
    Final pathology shows tumor confined to prostate.
    5 lymph nodes, seminal vesicules, extraprostatic soft tissue all negative.
    1.0 x 0.6 x 0.6 cm mass involving right posterior inferior, right posterior apex & left
    mid posterior prostate. Right posterior apex margin involved by tumor over 0.2 cm length,
    doctor says this is insignificant.
    Prostate 98 grams, tumor 2 grams.
    Catheter out in 7 days. No incontinence, minor dripping for a few weeks.
    Eight annual post-op exams 2012 through 2019: PSA <0.1
    Semi-firm erections without "training wheels," usable erections with 100mg Sildenafil.
    NOTE: ED caused by BPH, not the surgery.

  7. #7

    Post (P005) Ultrasensitive PSA Identifies Patients With Organ-Confined Prostate Cancer Req

    April 30, 2015 | ARS 2015

    Jung Julie Kang, MD, PhD, Robert Reiter, MD, Patrick Kupelian, MD, Michael Steinberg, MD, Christopher R. King, PhD, MD; Department of Radiation Oncology, Department of Urology, UCLA
    PURPOSE/OBJECTIVES: Randomized controlled trials have shown that adjuvant radiotherapy (RT) after radical prostatectomy (RP) improves biochemical relapse-free and overall survival in patients with extracapsular disease. However, even patients with organ-confined disease are at risk for failure. This study analyzes postoperative (postop) ultrasensitive prostate-specific antigen (uPSA) in the surveillance of these patients.
    MATERIALS AND METHODS: From 1991–2013, 146 patients with pT2N0 disease who were referred for a rise in PSA after RP were identified: 85 were margin-positive (m+), and 61 were margin-negative (m−). Surgical approach (open vs robotic), initial PSA (iPSA), Gleason grade, margin status, and postop uPSA were covariates for analysis. Median first postop PSA and follow-up were 3 and 38 months, respectively. The uPSA threshold was 0.01 ng/mL.
    Benign uPSA patterns occurred from 0.01–0.02 ng/mL; thus, ≥ 0.03 ng/mL was defined as uPSA failure. True (conventional) biochemical relapse (tBCR) was defined as PSA ≥ 0.2 ng/mL. Patients were censored at last follow-up or adjuvant therapy. Kaplan-Meier and Cox multivariate analyses were used to compare tBCR rates.
    RESULTS: Median time to tBCR for the entire cohort was 50 months. The m+ patients revealed a more indolent course than m− patients (median time to relapse: 86 mo for m+ vs 33 mo for m−; P = .0003). No differences in Gleason grade or iPSA between m+ and m− patients were seen.
    On multivariate analysis (MVA), only first postop uPSA ≥ 0.03 ng/mL (hazard ratio [HR] = 4.1; P < .001) and margin status (m−: HR = 5.6; P = .0315) independently predicted for time to tBCR.
    First postop uPSA ≥ 0.03 ng/mL discerned tBCR with much greater sensitivity than undetectable first conventional PSA < 0.2 ng/mL (44% vs 19%). First postop uPSA < 0.03 ng/mL vs. ≥ 0.03 ng/mL predicted median tBCR at 61 vs 10 months (P = .0003). Any postop uPSA ≥ 0.03 ng/mL captured all failures missed by analyzing only the first postop value (100% sensitivity).
    Using uPSA ≥ 0.03 ng/mL to identify relapse yields a substantial (33 mo) lead time advantage over waiting until conventional relapse at PSA ≥ 0.2 ng/mL (median 17 vs 50 mo in favor of uPSA ≥ 0.03 ng/mL).
    CONCLUSIONS: Only first postop uPSA ≥ 0.03 ng/mL and margin status independently predicted biochemical relapse for organ-confined prostate cancer. The m− patients exhibited much earlier failures, suggesting greater biologic aggressiveness.
    Biochemical failure can be called at uPSA ≥ 0.03 ng/mL with excellent sensitivity, and adopting it offers an impressive lead time advantage over the conventional failure definition (PSA ≥ 0.2 ng/mL).
    Integrating uPSA into the immediate and continued frequent surveillance of RP patients with organ-confined cancer will improve postop RT outcomes by identifying failures sooner and promoting an early salvage strategy.
    Proceedings of the 97th Annual Meeting of the American Radium Society — americanradiumsociety.org

    Courtesy: CancerNetwork

  8. #8

    Post Usefulness of ultra-sensitive psa following radical prostatectomy


    This study aimed to evaluate the usefulness of ultra-sensitive prostate-specific antigen (PSA) following radical prostatectomy (RP). Between September, 2003 and March, 2009, a total of 311 prostate cancer patients underwent antegrade RP; following the exclusion of 111 patients due to prior hormonal therapy, 200 patients were finally included in this study. The results of the multivariate analysis identified RP Gleason score, extraprostatic extension, lymph node metastasis and PSA nadir as significant predictors of biochemical failure (P=0.0116, 0.0216, 0.0178 and <0.0001, respectively) and PSA nadir <0.008 ng/ml exhibited the highest hazard ratio (HR) [HR=26.34; 95% confidence interval (CI): 7.34–104.69]. After a median follow-up period of 52.2 months, the biochemical failure-free rate in the PSA nadir <0.008 and ≥0.008 ng/ml groups was 94.3 and 58.8%, respectively, with a statistically significant difference according to the log-rank test (P<0.001). In the multivariate analysis, statistically significant differences were observed only in pathological nodel stage within the PSA nadir <0.008 ng/ml group (P=0.0107). For this reason, postoperative follow-up using ultra-sensitive PSA is considered to be of value, since the use of high-sensitivity PSA to confirm a reduction to below postoperative measurement threshold value (PSA nadir <0.008 ng/ml) may avert administering unnecessary additional treatment, regardless of pathological reccurrence factors.

    Keywords: prostate cancer, ultra-sensitive prostate-specific antigen, prostate-specific antigen nadir, biochemical failure, radical prostatectomy, Japanese

    Read full article here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106725/

    Articles from Molecular and Clinical Oncology are provided here courtesy of Spandidos Publications

  9. #9

    Post Prostate-Specific Antigen (PSA) Ultrasensitive, Serum

    Test ID: PSAU

    Prostate-Specific Antigen (PSA) Ultrasensitive, Serum

    Useful For:

    Monitoring disease after radical prostatectomy

    This test should not be used for initial prostate cancer screening.

    Clinical Information:

    Prostate-specific antigen (PSA) is the most widely used method to detect prostate cancer recurrence after radical prostatectomy (RP). Approximately 20% to 35% of patients develop a rising PSA following RP for clinically localized prostate cancer. Biochemical recurrence (BCR) is defined as an increase in PSA after curative therapy without clinical or radiological evidence of disease. The median time to biochemical recurrence (BCR) could vary between 2 to 3 years. A standard PSA cutpoint to indicate BCR has yet to be established. For example, the American Urological Association and the American Society for Radiation Oncology defined BCR after surgery as initial and confirmatory PSA concentrations of 0.2 ng/mL or greater. However, a BCR definition of 0.4 ng/mL PSA has also been proposed.

    Assays that measure PSA to concentrations below 0.1 ng/mL are denoted ultrasensitive PSA (USPSA). The use of USPSA cutpoints below currently recommended PSA thresholds may be helpful in identifying cases of early biochemical recurrence and for selecting patients with adverse clinicopathologic risk factors for secondary therapy. However, some authors believe that USPSA assays offers minimal advantages and could lead to increased anxiety in patients who have clinically meaningless rises of PSA and might lead to overtreatment.

    Reference Values:

    Age (Years) PSA Upper Limit (ng/mL)
    <40 < or =2.0
    40-49 < or =2.5
    50-59 < or =3.5
    60-69 < or =4.5
    70-79 < or =6.5
    > or =80 < or =7.2

    Females: not applicable


    An undetectable (<0.01 ng/mL) ultrasensitive prostate-specific antigen (PSA) concentration after radical prostatectomy is reassuring and may aid in postoperative risk stratification of patients.

    A detectable PSA concentration (> or =0.01 ng/mL) after radical prostatectomy does necessarily translate into disease progression or recurrence. Interpretation of a detectable PSA needs to be made in conjunction with other clinicopathologic risk factors. The cutpoint for interpretation of ultrasensitive PSA assays remains controversial and has ranged from 0.01 to 0.05 ng/mL. For example, in a study that included 754 men after RP, a cutpoint of 0.01 ng/mL was an independent predictor of BCR. BCR-free survival at 5 years was 92.4% for patients with a PSA post-RP of less than 0.01 ng/mL and 56.8% for patients with a PSA post-RP of 0.01 ng/mL or higher.(1) In the same study a cutoff of 0.03 ng/ml also predicted BCR independent of clinicopathological factors and BCR-free survival at 5 yrs was 90.8% for patients with a PSA post-RP of less than 0.03 ng/mL and 26.9% for patients with a PSA post-RP of greater or equal to 0.03 ng/mL.(1)


    For 12 hours before this blood test do not take multivitamins or dietary supplements containing biotin or vitamin B7, which are commonly found in hair, skin, and nail supplements and multivitamins.

    Serum markers are not specific for malignancy, and values may vary by method.

    When age is not supplied, the results cannot be flagged as high or low.

    Digital rectal examination generally does not increase normal prostate-specific antigen (PSA) values. However, cystoscopy, urethral instrumentation, and prostate biopsy may increase PSA levels.

    Some patients who have been exposed to animal antigens, either in the environment or as part of treatment or imaging procedure, may have circulating antianimal antibodies present. These antibodies may interfere with the assay reagents to produce unreliable results.

    No interference was observed from rheumatoid factors up to a concentration of 1,500 IU/mL.

    There is no high-dose hook effect at total PSA concentrations up to 17,000 ng/mL.

    Clinical Reference:

    1. Sokoll LJ, Zhang Z, Chan DW, et al: Do Ultrasensitive Prostate Specific Antigen Measurements Have a Role in Predicting Long-Term Biochemical Recurrence-Free Survival in Men after Radical Prostatectomy? J Urol 2016 Feb;195(2):330-336
    2. Thompson IM, Valicenti RK, Albertsen P, et al: Adjuvant and salvage radiotherapy after prostatectomy:AUA/ASTRO Guideline. J Urol 2013 Aug;190(2):441-449
    3. Mir MC, Li J, Klink JC, et al: Optimal definition of biochemical recurrence after radical prostatectomy depends on pathologic risk factors: Identifying candidates for early salvage therapy. Eur Urol 2014 Aug;66(2):204-210

    Courtesy: Mayo Clinic/Mayo Medical Laboratories

  10. #10
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    J Urol. 1993 Apr;149(4):787-92.

    Early detection of residual prostate cancer after radical prostatectomy by an ultrasensitive assay for prostate specific antigen.

    Stamey TA1, Graves HC, Wehner N, Ferrari M, Freiha FS.
    Author information


    We evaluated the usefulness of an ultrasensitive immunoassay for prostate specific antigen (PSA), modified from the standard Yang Pros-Check PSA test and with a biological detection limit for PSA in serum of 0.07 ng./ml., to detect residual prostate cancer at an earlier date. We studied retrospectively serial frozen serum samples from 22 prostate cancer patients after radical prostatectomy who later had residual cancer with detectable PSA levels of 0.3 ng./ml. or more by the standard PSA test. As controls we studied 33 cystoprostatectomy patients (for bladder cancer) without histological evidence of prostate cancer and 23 patients after radical prostatectomy who had the highest probability of cure of the cancer. All control patients without cancer had PSA values (282 of 283 samples, 99.6%) of less than 0.1 ng./ml. This value was called the residual cancer detection limit. In the 22 patients with recurrent cancer the ultrasensitive assay detected cancer recurrence (PSA 0.1 ng./ml. or more) much earlier (median 202 and mean 310 days) than the standard assay (PSA 0.3 ng./ml. or more). On screening 187 current post-radical prostatectomy patients without evidence of cancer by the standard assay the ultrasensitive assay detected 21 (11.2%) with evidence of residual cancer, that is PSA level of 0.1 ng./ml. or more. We conclude that an ultrasensitive assay for PSA can detect residual cancer after radical prostatectomy much earlier than current immunoassays for PSA. Earlier detection of residual cancer may improve long-term survival by allowing for earlier institution of adjuvant therapy.

    PMID: 7681119


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