Difference between labs seems high--any ideas

insignificant difference...the big picture is what's important

You'd be fine saying, "My latest test result is around 11 ng/mL"

As has been said professionally, PSA is not a constant. You can take a PSA test at 8:00am and one at 5:pm and have a significant difference. That is one reason to not be hasty with decision making. In addition from one lab to the next can vary depending on assay and style of the person performing the test.

Terry Herbert did a psa test every day for 30 days and daily difference was 30%. Psa also changes with the season. Strum recommends taking the test at the same time of day and the same months and use the same lab for consistent readings.

Allen that's interesting. I know a guy that drank a couple gallons of water for two days ahead of testing gave him the lowest PSA. Of course you have to ask if diluting or attempting to tweak a PSA lower is wise? Per John's Strum comments I fear the same thing. Is trying to get your PSA to the lowest point at the time the needle goes in logical? If one's PSA ranges from 2 to 4 during the day would it not be more valuable to know the high number rather than the low number? Just a hypothesis...

We need that trial.

Yea I understood his point but that does not address my point. But it's irrelevant to Sonny's post and I'll raise my hypothesis at PCAF for future discussion.

As far as the S1216 protocol definitions. The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.

From the protocol capsule:

1.1 Primary Objective
The primary objective of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.

1.2 Secondary Objectives
Secondary objectives include the following:
a. To compare progression free survival (as defined in Section 10.5) between the two arms.
b. To compare distributions of PSA response (< 0.2 vs. 0.2-4.0 vs. > 4.0 ng/ml) between the treatment arms at 7 months post-randomization.
c. To compare the qualitative and quantitative adverse events from each treatment arm.
d. To characterize the long-term survival in both treatment arms after 10 years of follow-up.

1.3 Other Objectives
Other objectives include the following:
a. To validate the prognostic and predictive value of markers of bone turnover in newly-diagnosed metastatic hormone sensitive prostate cancer patients treated with TAK-700.
b. To bank serum/whole blood and tissue specimens for future use.

Sonny is eligible to stay on protocol and/or:

7.2 Concomitant Therapy
The use of supportive care medications is allowed according to institutional standards.
Several medications are specifically disallowed. Five-alpha reductase inhibitor (e.g. finasteride and dutasteride) are not permitted. Other excluded therapies include ketoconazole, aminoglutethimide, abiraterone acetate, enzalutamide (MDV3100), diethylstilbestrol/DES, and other estrogen preparations.

7.4 Criteria for Removal from Protocol Treatment:
a. Progression of disease or symptomatic deterioration (as defined in Section 10.3).
b. Unacceptable toxicity due to LHRH agonist. NOTE: Patients off bicalutamide or TAK 700, but continuing on LHRH agonist remain on protocol treatment.
c. Delay in LHRH agonist greater than 60 days.
d. Beginning a new systemic treatment for prostate cancer.
e. The patient may withdraw from the study at any time for any reason.

We did a modification that was approved to allow docetaxel + prednisone.

Tony-
Section 10.3 has bearing on Sonny's question, since the study's definition of PSA progression is given there. Did they use the PCWG2 definition or did they use a stricter definition, as studies sometimes do?

- Allen

Allen and Sonny....From the SWOG capsule. This is how progression is defined. It's not PCWG2 alone, I don't think but you may know more than I about that. PCWG2 states a 2ng/ml increase above nadir. SWOG and NCI defined it with CTEP. #1 below can be defined as progression for Sonny but I'm not sure that a retest isn't worth while since he did show a drop in a retest. He could come back lower again and this was a fluctuation that on it's own could have been an anomaly. He needs to get with his doctor on this and they were looking at a revisit soon. I wish ya the best on that Sonny.

10.2 Progression Criteria
One or more of the following must occur:
1. ≥ 25% increase AND an absolute increase of at least 2 ng/mL from the nadir PSA (or from baseline PSA if there was no drop in PSA after starting treatment).
2. Progression on bone scan is defined as 2 or more new lesions on radionuclide bone scans. Should two or more new bone lesions be evident at the first assessment on treatment (Month 13), two or more additional new lesions must be evident on a confirmatory assessment at least 6 weeks later. This confirmation is not required when 2 or more new lesions first appear after Month 13.
3. Soft tissue progression per RECIST 1.1 criteria. Twenty percent increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site.
4. Death due to disease without prior documentation of progression and with symptomatic deterioration (see Section 10.3).

Notes regarding new lesions: FDG-PET imaging can complement regular scans in identifying new lesions according to the following algorithm.
1. Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of progression based on a new lesion.
2. No FDG-PET at baseline and a positive FDG-PET at follow-up corresponding to a potential new site of disease must have a confirmation by anatomical assessment (e.g. CT, MRI, x-ray) as new site of disease to be considered progressive disease. In such a case, the date of progressive disease will be the date of the initial abnormal FDG-PET.
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Sonny I'm trying to get my schedule right to come down. Can you call me and tell me the schedule in LA?