PSA ‘<‘ value meaning

hmoo

i had RP if feb 2017 (Gleason 4+4 with intraductal features - decipher very high - .93). Very fortunate to have been <.008, but layest test which was done at a different lab reported a PSA of <.064.

Does this mean the assay is incapable of detecting less than .064, so  I am likely still undetectable?

Clevelandguy

Base readings

Hi hmoo,

According to my urologist most labs should be able to get down to <.01 which is considered undetectable by my doctor.  If I understand you correctly the 1st PSA reading was <.008?  If it was done by the same lab then they should be able to detect that level again on future tests.  Could this be a lab error?  Did the second test use a different lab?

Dave 3+4

hmoo

Clevelandguy said:

Base readings

Hi hmoo,

According to my urologist most labs should be able to get down to <.01 which is considered undetectable by my doctor.  If I understand you correctly the 1st PSA reading was <.008?  If it was done by the same lab then they should be able to detect that level again on future tests.  Could this be a lab error?  Did the second test use a different lab?

Dave 3+4

Thanks clevelandguy.

Thanks clevelandguy.

Yes it was performed at a different lab. seems weird they would report to three decimal places, but only be able to detect to .064. I have read before that the ‘<‘ means it is low as the test goes in detection, but .064? 

Regulator

hmoo,

hmoo,

I think you've already received your answer here, but I'll add a bit more in hopes that it might help some. I'm an analytical chemist by education, training and work experience, and in this case, the devil is in the details. When an analyst tests a blood, serum or urine sample for a particular analyte like PSA, they are essentially performing two different tests  . . . one qualitative and one quantitative. One is simply designed to determine whether the substance is in-fact present (a presumptive positive or negative), while the other, is designed to determine 'how much' of the substance is present (if any).

In that final (quantitative) stage of the analysis, the technician (or the instrument's computer software) typically compares the response of the patient sample to the response of an array of known standards (controls known to contain a certain fixed aount of the analyte). at varying concentrations. Based upon the responses of those known standards, a linear regression analysis is establlished, and two very important parameters are then determined . . .

1) Limit of Detection (LOD), and

2) Limit of Quantitation (LOQ):

The LOD (Limit of Detection) is defined as the lowest possible concentration that the instrument is capable of detecting 'qualitatively' (not quantitatively), while still being capable of distinguishing it with confidence from the background noise (the so-called signal-to-noise ratio). In other words, below the LOD, the instrument cannot tell you with confidence that the subject molecule is even PSA.

Conversely, the LOQ (Limit of Quantitation), is defined as the lowest possible concentration that the instrument is capable of detecting 'quantitatively', while still being capable of distinguishing it (within specified confidence intervals), from background noise. The LOQ is typically one full order of magnitude larger than the LOD (or more). Thus, your laboratory result of 0.064 ng/mL means that on that day, using the set of quantitative standards and quality controls available to them at the time, the instrument employed by that particular laboratory was incapable of accurately identifying and 'measuring' (or quantitating) the PSA below 0.064 ng/mL.

Given that explanation, could your PSA have actually been 0.011 or 0.008 or even 0.001 ng/mL at the time? Yes to all, because all three values are below the reported Limit of Quantitation (LOQ). Are you still likely to be "undetectable"? I'm afraid there's no accurate answer to that because "detectability" is strictly dependent on a given lab, a given instrument, a given set of standards and controls, and a given set of atmospheric conditions (i.e., signal-to-noise).

I hope that helps.

hmoo

Thank you regulator

The time and effort you spent to explain and educate was incredibly kind and generous. You have also answered a question that I am sure others have had. 

Two takeaways:

1) use the same lab and assay;

2) ‘< than’ means - the test can only detect to this number, so the actual number is somewhere between zero and this number.

I asked my doctor if I should take another test with the same assay that was originally used, and he advised not to worry as we were testing ‘psa velocity ‘ and this was just a ‘data point’. Confused by his response as going from .008 to .064 would seem to indicate a pretty agessive progression  (Velocity). He’s a very sharp guy though, so I think he thinks I’m still undetectable. Sure hope I am, because if i progress, given my scores, I’m in for a tough road ahead.

Thank you again.

Old Salt

Yes

Your doctor is right. Your can't really compare 0.008 to 0.064 (your PSA results) because those data came from different instruments/labs. 

Regulator

hmoo said:

Thank you regulator

The time and effort you spent to explain and educate was incredibly kind and generous. You have also answered a question that I am sure others have had. 

Two takeaways:

1) use the same lab and assay;

2) ‘< than’ means - the test can only detect to this number, so the actual number is somewhere between zero and this number.

I asked my doctor if I should take another test with the same assay that was originally used, and he advised not to worry as we were testing ‘psa velocity ‘ and this was just a ‘data point’. Confused by his response as going from .008 to .064 would seem to indicate a pretty agessive progression  (Velocity). He’s a very sharp guy though, so I think he thinks I’m still undetectable. Sure hope I am, because if i progress, given my scores, I’m in for a tough road ahead.

Thank you again.

Hmoo

Hmoo

You're quite welcome, and I can fully appreciate why you're a bit perplexed by your doctor's response. A doubling of 0.008 is obviously 0.016, so you're right, a result of <0.064 is 8x higher than the original and not particularly informative or reassuring. If possible, the overall best solution would clearly be to have the original laboratory (the one reporting with a lower LOQ), analyze your most recent specimen (apples to applies, not apples to oranges). However, to some extent, its important to keep these numbers in context. A result of <0.064 ng/mL means that there were fewer than 64 molecules of PSA present in every 'trillion' molecules of specimen (not an awful lot), and by comparison, my own current PSA value of 69 ng/mL, is 1,000 times greater (which, by the way, I'm hoping to depress very very soon). 

Best of luck!

VascodaGama

I think he thinks I’m still undetectable ....

In my opinion your doctor got his own thresholds to judge outcomes. Remission after RP is considered by most when the PSA is under 0.06 ng/ml, but many take it as PSA=0.1 ng/ml. The threshold for recurrence is by tradition a PSA=0.2. Surely these thresholds may differ from patient to patient (we are different with different cases) and an increase in some particular cases could signal cancer activity but to treat due to a simple increase of the PSA may not be the best way to advance with a salvage treatment(s) because these do not assure cure if targets are not identified.

I sense you are worried for for the negative wording in your post like; " ... still undetectable ...." or " ... I’m in for a tough road ahead ...". I believe that the result of the Decipher test is making you anxious and so you may think that you are at an urgent need for additional treatment. However, the test just quantifies the risk for metastases after RP or the response of your type of cells to hormonal therapies. It does not identify recurrences or cancer's location. You must wait for such a classification given by your doctor (if ever) and you would need targets for treatment obtained via image studies. Otherwise you would follow a guessing approach based in experiences from therapies done on others.
One can try and be lucky but variations of the PSA lower than 1.0 ng/ml doesn't assure better outcomes with earlier interventions. The PSA at 0.06 is low. You have time to gather more evidences before deciding on the need of a salvage therapy and its protocol.

Hope for the best.

VG

hmoo

Regulator said:

Hmoo

Hmoo

You're quite welcome, and I can fully appreciate why you're a bit perplexed by your doctor's response. A doubling of 0.008 is obviously 0.016, so you're right, a result of <0.064 is 8x higher than the original and not particularly informative or reassuring. If possible, the overall best solution would clearly be to have the original laboratory (the one reporting with a lower LOQ), analyze your most recent specimen (apples to applies, not apples to oranges). However, to some extent, its important to keep these numbers in context. A result of <0.064 ng/mL means that there were fewer than 64 molecules of PSA present in every 'trillion' molecules of specimen (not an awful lot), and by comparison, my own current PSA value of 69 ng/mL, is 1,000 times greater (which, by the way, I'm hoping to depress very very soon). 

Best of luck!

Your results

i feel a little silly worrying about my results when I see so many who are in the thick of the battle such as yourself. Best of luck!

BTW- have you heard about lu-psma617? Just going into phase 3 trials. It binds to the pmsa and destroys it with radiation. Similar to the gold standard treatment used for thyroid cancer ablation, except that the thyroid treatment binds to iodine (thyroid cancer loves iodine!) I have undergone the thyroid treatment and am in remission.

Patients with castrate resistant pca are being recruited, so it is currently targeting very advanice-stage subjects. But because the safety profile looks so encouraging, there is hope that it might be possible to intervene as a pre-chemo therapy for those in earlier stages.

You might want to keep an eye out on that trial (VISION is the name)

All the best 

 

hmoo

VascodaGama said:

I think he thinks I’m still undetectable ....

In my opinion your doctor got his own thresholds to judge outcomes. Remission after RP is considered by most when the PSA is under 0.06 ng/ml, but many take it as PSA=0.1 ng/ml. The threshold for recurrence is by tradition a PSA=0.2. Surely these thresholds may differ from patient to patient (we are different with different cases) and an increase in some particular cases could signal cancer activity but to treat due to a simple increase of the PSA may not be the best way to advance with a salvage treatment(s) because these do not assure cure if targets are not identified.

I sense you are worried for for the negative wording in your post like; " ... still undetectable ...." or " ... I’m in for a tough road ahead ...". I believe that the result of the Decipher test is making you anxious and so you may think that you are at an urgent need for additional treatment. However, the test just quantifies the risk for metastases after RP or the response of your type of cells to hormonal therapies. It does not identify recurrences or cancer's location. You must wait for such a classification given by your doctor (if ever) and you would need targets for treatment obtained via image studies. Otherwise you would follow a guessing approach based in experiences from therapies done on others.
One can try and be lucky but variations of the PSA lower than 1.0 ng/ml doesn't assure better outcomes with earlier interventions. The PSA at 0.06 is low. You have time to gather more evidences before deciding on the need of a salvage therapy and its protocol.

Hope for the best.

VG

Thanks vgm

Very informative, especially the context you provided on decipher.  Many thanks