What We're NOT Supposed to Know

Randy has now been in a clinical trial for 133 weeks. Yesterday was his quarterly check up at Emory. (The President was in Atlanta yesterday....can I tell you what that did to the traffic situation?) We went, as usual, to the lab upon arrival. As always, they took two sets of blood samples. One is for use by the docs at Emory and one is sent to the trial sponsor. Since this is a double-blind study, we nor the doctors know the results of the PSA test. The only exception to that have been when Randy's PSA reached undetectable the first time, we knew because treatment was discontinued, and when his PSA subsequently rose to 2.0, treatment was restarted. The protocol only allows for one "break" in treatment, so since he restarted we have been completely in the dark.

Yesterday, we went in to see the doctor and all went well. Usually the blood work results are in hand when the doctor comes into the room. Yesterday, they weren't, so we waited around for the results. After a while, our clinical trial rep came into the room with the results in hand. The first words out of her mouth were: "This is going to be an awkward conversation". (Queue the clenched stomach) But as it turns out, the news was good news. It seems that someone in the lab made a error and processed the samples for PSA. Medical ethics, we were told, require that we be informed of any test results that our doctors have access to, so for the first time in a long, long time, we know Randy's PSA. Drum-roll, please....0.01.

This is such a relief. Previously, I found a reference on his scan report that showed his diagnosis as "Prostate Cancer with Rising PSA". The PA assured me that they had just picked up that diagnosis from a previous scan, and that the pathologist was as uninformed regarding his PSA as we were. I was afraid that Randy was becoming castrate resistant. It turns out he's not. Yesterday was a good day (traffic not withstanding). Sometimes it's a good thing to know what you're not supposed to know.

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55 at dx PSA-7/14: 26
Bx-8/14: 8 of 8 cores+(80-100%) GL7;
9/14-Bone/CT Neg.
10/22/14: RP
Post-OP Path:GL9; LN+; margins+; SV+, L Bladder neck+
pT3bN1
PSA-7 wks post op-10.0; 11 wks-14.2;
ADT 1/15 to1/16
F18 PET/Chest CT/MRI-Neg.(3/15)
SRT 3/15-7/15
9/15 to 3/16 PSA <.05
PSA 6/10/16 .46; 7/8/16 1.0; 8/2/16 1.2; 8/26/16 1.7; 9/22/16 2.5
10/16-EMBARK
6/17-PSA<.05-meds stopped
2/18-PSA 2+restart med

Whoever messed up with the lab report release deserves a BIG thanks.....

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72years old @ Dx, LUTS for 7 years
Ulcerative Colitis since 1973
TURP 2/16, G3+4 discovered,
4 cores; G 3+3, one G3+4
RALP 7/17 G3+4 Organ confined, but...
<1mm positive margin on Epstein check
pT2c pNO pMn/a
PSA .54 4 months post RR
ercMRI & DCFPyL PET Scan @ NIH/NCI
1" tumor in cavity at apex No mets.
IMGT 70.2 GY, 2ADT, over 5/18
PSA <.006 9/18, .054 11/18, .070 12/18, .067 2/19

Great news. I bet the drive back home was way better than the one there even with the traffic!

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Age 53
PSA 2.7 (8/2017), 4.17 (8/18), 4,7 (10/18), 5.5 (11/27/18),4.77 (4/23/19)
BX scheduled for 10/26/18
Dx 11/1/18, G6 3+3 2 of 12 samples
5%
35 cc

If you're curious in the future, you can always request your own PSA test through an independent lab like Labcorp. You don't need to live with such an unknown, and you don't have to reveal your knowledge to the study.

Just a thought...

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55@Dx on 4/16/13. PSA 5.2, G9(5+4), PNI+, cT3a by MRI.
IGRT - 44 sessions (79.2 Gy, 50.4 Gy pelvic)
ADT2 - Lupron+Casodex (5/13-3/16)

PSA:
8/13-5/16 <0.1 (ADT2)
5/16-3/17 recovering from ADT2
3/17-12/18 up and down ~ 0.6 - 1.0 (no TX)
latest 3/19 = 0.7

My Story

Redwing,
That’s a great idea and something I would likely do. I was thinking as I read the OP, what difference does it make in this study if everyone knows the PSA? There aren’t any judgement calls - it all seems objective based on the PSA numbers. Doesn’t seem like the need for being double blind.

Great news!

Yay, RandyJoe!

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PSA 10.9 ~112013
Bx on 112013 at age ~65yrs, with 5 of 12 pos, G9(5+4), T2B.
RALP with lymph nodes at Vanderbilt 021914. (nodes clear, SV+, G9 down graded to 4+5, 1 focal margin )
only rare pad use after 1 year
PSA <.01 on 6/14 and all until 9/15 = .01, still .01 9/16, .02 on 3/17,6/17,10/17, .06 1/18, .06 4/18, <.05 7/18, .06 10/18, .06 04/19

Thanks to all!

Mattam and Redwing: we've thought about getting a PSA test done outside the trial, but for the most part we're 'rule-followers'. I don't really know the reason why the PSA is blinded, but it is, and we agreed to that going in. It's hard and I'm a bit of a Life-Manager (my husband says it's more like Control Freak), but we assume that whoever designed the trial had a reason for this beyond making me crazy.

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55 at dx PSA-7/14: 26
Bx-8/14: 8 of 8 cores+(80-100%) GL7;
9/14-Bone/CT Neg.
10/22/14: RP
Post-OP Path:GL9; LN+; margins+; SV+, L Bladder neck+
pT3bN1
PSA-7 wks post op-10.0; 11 wks-14.2;
ADT 1/15 to1/16
F18 PET/Chest CT/MRI-Neg.(3/15)
SRT 3/15-7/15
9/15 to 3/16 PSA <.05
PSA 6/10/16 .46; 7/8/16 1.0; 8/2/16 1.2; 8/26/16 1.7; 9/22/16 2.5
10/16-EMBARK
6/17-PSA<.05-meds stopped
2/18-PSA 2+restart med

I’ll venture a guess as to the reasoning- why not let you know? If the results are bad you might be less likely to follow the Trial to its conclusion, and THATs their motive, to test to conclusion...

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Age 57, NYS
Diag PC May ‘18 PSA 43; high 97.8
PC Stage IV (CT/PET scan; Lymph/bone mets)
Casodex May/June '18
6/5/18 PSA=48.35
6/22 PSA=41.31
6/25 Taxotere at Wilmot (URMC) 6*3 wk regimen+ Lupron
7/16 PSA=28
8/3 " =8.90
8/24 "=6.86
9/17 "=6.61
10/4 "=5.21
10/29"=4.04
12/17"=4.21
2/6/19”=4.79
4/2”=13.82
4/5”=16.87
4/18”=20
Diet since Diag - 95% Pescatarian/Gluten (Almost) free, no Alc.

I have one of those living with me, RandyJoe!

A crazy, life managing, control freak.... It comes with age, God bless her ;-) and you!