USPSTF to re-assess harms and benefits of PSA-based screening for risk of prostate cancer

Yesterday the U.S. Preventive Services Task Force (USPSTF) posted detailed information about a new draft research plan related to screening for prostate cancer.

The USPSTF is seeking public comment on this plan, which can be reviewed here, and public comment can be submitted from now through November 25, 2015.

Prostate Cancer International has already submitted detailed comments on this draft research plan to the USPSTF through the USPSTF web site. Doing this is not complex, but it can take a little time, and we would encourage those who are interested in making such comment to be thoughtful in so doing.

Here is a list of just a few of the comments submitted by Prostate Cancer International with respect to the plan:

  • It is unclear whether the plan and the related research questions were written before its authors were aware of the data published yesterday in the New England Journal of Medicine related to the effect of PSA testing on initial diagnosis of men with metastatic prostate cancer at first presentation (see here).
  • The plan and the related research questions fail to discriminate between the benefits and harms associated with (a) drawing blood for PSA testing and (b) the process of making decisions based on the results of a PSA test (whether or not the patient is well informed of the potential benefits and harms).
  • Despite strong evidence that there is a subset of prostate cancer patients whose risk for prostate cancer can initially be identified by digital rectal examination (DRE) — even while such patients’ PSA levels are well within the “normal” range, the plan and the related research questions make no mention of the potential of DRE testing in association with PSA testing in screening for risk of early stage prostate cancer. We see this as a major omission (although we appreciate that there are men for whom the DRE is felt to be a very distressing form of medical examination).
  • The plan and related research questions fail to even address the key issue of the harms and benefits of having a prostate biopsy, and the many things that can now be done to (a) help to determine whether such a biopsy is necessary and (b) ensure that the quality of such a biopsy is optimized (e.g., by the use of MRI scans prior to biopsy).
  • The plan and the related research questions fail to take account of the availability of newer tests like the 4KScore test and the Prostate Health Index or phi test which may be helpful to clinicians and to men with an elevated PSA level in determining whether a prostate biopsy is necessary at all.
  • The plan and the related research questions repeatedly “lump together” all possible options for management of localized prostate cancer as “treatments”. This is misleading. There is a major distinction between the invasive first-line treatments (surgery, radiation therapy, cryotherapy, ultrasound, etc.) and the two basic forms of monitoring (active surveillance and watchful waiting).  The latter are not treatments at all. They are management processes used to determine, over time, if and when certain types of treatment may become necessary.

(Do please note that this is not a detailed list of all the comments submitted by Prostate Cancer International.)

Prostate Cancer International believes that the USPSTF is seeking to conduct a serious re-evaluation of the value of screening for prostate cancer based on PSA testing of men who fall into certain appropriate categories.

The 2012 recommendation made by the USPSTF against the use of PSA testing has, as we all appreciate, been highly controversial. For those who simply wish to encourage the USPSTF to conduct a serious re-evalution of their 2012 recommendation, taking account of the input of prostate cancer patients, prostate cancer specialists, and men’s health advocacy groups of a variety of types, you can just click here and leave some form of message like the one below:

New Draft Research Plan for Prostate Cancer Screening

As a prostate cancer patient, I strongly encourage the USPSTF to implement a thorough re-evaluation of the value of the PSA test — along with other appropriate follow-up tests and the delivery of appropriate information to patients — as a simple and relatively risk-free method of helping men to know their risk for prostate cancer. The risk associated with the PSA test itself is small by comparison with the subsequent risks of biopsy and treatment and the risk of delayed diagnosis (and delayed treatment) of men at risk for clinically significant prostate cancer.

The major decline in the numbers of men being diagnosed at first presentation with metastatic prostate cancer (recently reported by Welch et al. in the New England Journal of Medicine) since the widespread availability of the PSA test is a critical factor in any and all decisions about the value of screening for prostate cancer. If even a relatively small percentage of all the men who used to be diagnosed with metastatic prostate cancer are now being cured of their prostate cancer because of early detection, this raises very serious questions about the importance and value of PSA screening as a way to detect clinically significant prostate cancer early. The problem is not inherently the PSA test. The problem is what clinicians and patients do with the information resulting from the PSA test and subsequent actions taken (from how to determine the need for prostate biopsy to the appropriate management of patients on active surveillance or watchful waiting as opposed to immediate invasive therapy). The perceived over-diagnosis and over-treatment of forms of prostate cancer that can be managed conservatively is not in any way a consequence of PSA testing. It is a consequence of the behaviors and recommendations of clinicians who offer less than stellar guidance to their patients.

You are also required to leave an e-mail address so that your comment can be accepted by the USPSTF system, but this does not mean that you will be placed on any sort of spam e-mail list.

Please feel able to copy and paste the above message or to adjust it in any way that you feel appropriate.

6 Responses

  1. Reblogged this on Dan's Journey through Prostate Cancer and commented:
    This is a very important opportunity to let our voices be heard with respect to the recent USPSTF changes in PSA screening recommendations.

  2. God help us! (Mean it!) The USPSTF is STILL Stuck in the Past!

    My heading will not be news to many of us, but as I’m beginning to review the USPSTF plan, I was a bit stunned to see that their two key references on screening are the initial PLCO and ERSPC reports from 2009! Why is there no mention of the 13-year update of the ERSPC (4 more years of follow-up; 2014), which shows a far more favorable prospect for screening including a highly suggestive trend, even with the mild form of screening (mostly a 4-year interval) generally used in the ERSPC? Why is PLCO being given any credit at all in assessing screening at this point in 2015, now years since the extremely high degree of contamination (heavy screening in the usual care arm) has discredited evidence on screening from PLCO (among other credibility issues, including very short and immature follow-up)?

    I will be tactful in my input to the USPSTF, but really folks, how can the USPSTF be so ignorant? I thought I was beyond being surprised by the USPSTF, but they still have the capacity to amaze. (Not in a good way!)

    Thanks for this opportunity to vent. I actually am hopeful that the Task Force is open to a way to consider evidence that should at least push their recommendation back “up” to neutral, if not to a tentative endorsement of smart screening. (The lack of distinction between uninformed and smart screening is one of the points I’ll make.)

  3. Frustrated with the Task Force Web Site

    I tried to leave my first recommendation and complied carefully with all site instructions. However, when I clicked the “next page” button, the site gave me an error message and directed me to start over. This reminded me immediately that many of our comments were lost by the site several years ago when we tried to comment on the draft USPSTF guidelines regarding screening.

    Disappointed, frustrated, but hardly surprised. Par for the course for the USPSTF!

  4. Don’t be frustrated … Do it the old fashioned way … Write up your comments on each question and mail them in. The directions to do that are available on the site.

  5. After answering 7/10 of the question the site gave also an error and had to start again. … Followed Mike’s advice and did my input the old way. Wonder if it will make a difference. I feel better anyway!

  6. Submitted Comments Both Ways This Afternoon

    I went through the comment portal for detailed comments on the Analytic Framework diagram with 5 “Key Questions” and 3 “Contextual Questions,” plus on the Research Approach, which had segments covering data to be included or excluded regarding the study population, setting, interventions, comparisons, outcomes, duration, study designs, and timeframe. There is a limit on the number of characters of comment for each question and the Research Approach as a whole — about 4,000 characters as I recall it, but an attachment is allowed, and I used that to complete extra long responses on Key Question 3 and on the Research Approach. I also included my revision of the Analytic Framework diagram in my attachment. I first prepared my whole response in a Word Document, then pasted in comments, which worked very well. I got an e-mail acknowledgement that my comments had been received.

    Remembering the Task Force’s loss of a great many comments in 2011, I sent a mail backup copy at the post office this evening. The deadline for receipt of electronic and mail comments is 8 PM on 11/26, Thanksgiving Day, but I’m thinking they may accept any comments that arrive in the mail on Friday. No guarantees.

    There are reasonable limits on the number of pages as well as some reasonable format requirements. The key limit is that the mail submission cannot exceed 15 pages, including any attachments. I had a little leeway, but not much. Of course, it is also possible to skip questions and make just brief selective comments.

    The current Task Force seems to be more receptive to input than the previous group. Time will tell.

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