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Any News is Bad News (EMBARK Study)

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Posted 3/2/2018 1:10 PM (GMT -7)
As I posted on here earlier, we've left the last few doctors visits not knowing whether Randy's treatment would need to be re-started. Clinical trials can be heck on control issues. We've been told that if his PSA rose (above 2.0), we'd be notified to come in and restart treatment within 2 weeks. So, we've held our breath for the 2 weeks following each visit knowing that no news was good news. Wednesday was our last appointment. Today I came back from lunch to an e-mail from the clinical trial coordinator, asking for us to call her. This time there is news. We have to return next Wednesday for a re-start of treatment.

The hardest part of clinical trials is the not knowing. We don't know whether Randy is on the Lupron/Xtandi combo or the Lupron/Placebo combo. We don't know his PSA levels. The only time we've really known anything was when treatment was stopped (we knew he reached undetectable levels) and now that it's starting back (we know that his PSA has reached or passed 2.0).

I know we are blessed. Randy is still hormone sensitive and there are lots and lots of treatments still available....and we're still not done with this trial. All is not lost. This just really stinks out loud. When do we get used to this "new normal"?
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-Surg Path:GL9; LN+; margins+; SV+, L Bladder neck+
pT3bN1
PSA-7 wks post op-10.0; 11 wks post op-14.2;
ADT 1/15 to1/16
F18 PET/Chest CT/MRI-Neg. (3/15)
SRT complete 7/6/15
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
Posted 3/2/2018 1:30 PM (GMT -7)
I hear you! I’m three years into my journey and I’m still processing it. My navigation skills have improved and I’m thinking it will an ongoing challenge. I will meet it to the best of my abilities. Hang in there!
The tragic recommendations of the USPSTF led me to where I am.
Dx: April 2015, Age 54, pT3bN0MX; Initial PSA: 20.8
Bx: All cores high volume G7 (4+3)
Bone scan and MRI: clear
RALP: June 2015
Pathology: G8 (4+4), focal areas of 5; Positive margins; 3 Nodes negative
Adj. IMRT: Aug 2015
PSA nadir: 0.1
Steady PSA increase. Feb 2018: 11.4
CT and bone scans, July 2017: Clear; Feb 2018: Clear
Posted 3/2/2018 1:40 PM (GMT -7)
Good for you guys in researching and joining a trial. That’s awesome on several levels.

So, Xtandi comes with pretty significant fatigue. Is he pretty tired after his 4 pills?

I’m closing in on 9 years dealing with this. For me, it’s somewhat of a roller coaster ride...I’ve been through various phases of “new normal”...

Hang in there...
11/09 Dx at Age 44 ----- 4.03
12/09 DaVinci Surgery,t3b,g9 <.05
2/10 Adj. Radiation ----------- <.05
3/11 PSA Rise/Scans/Spot ---- .09
on Pelvic Bone
4/11 HT/XGEVA/Spot Radiation -- .06
2011-2012: ADT3: 15 months
2013-2015: ADT3 VACATION #1: 36 Months
2016: Spot on Rib; .07; ADT3; Spot Rad
2017-?: ADT3 VACATION #2:
Posted 3/2/2018 2:34 PM (GMT -7)
Jerry, Randy didn't really experience any significant side effects from Xtandi (if, in fact, he was taking Xtandi.
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
Posted 3/2/2018 2:44 PM (GMT -7)
The only thing I remember was that I seemed more tired. But then, I used to take it before bedtime.

Keep us posted...
Posted 3/2/2018 5:18 PM (GMT -7)
Thanks to both of you for participating in a clinical study. Without those studies, we would still be in the dark ages of medicine.
I can see that you are frustrated, but want to paint the big picture. Your husband has been getting excellent (free!) care, and he has shown a positive response to the therapy. Isn't that what really matters?
If this is a blinded study, the staff may not even know whether your husband is getting just Lupron or both drugs. All this must have been in the papers that were signed by the trial participants.

As an aside, people participating in a trial are always free to withdraw.

Post Edited (Sr Sailor) : 3/2/2018 6:26:49 PM (GMT-7)

Posted 3/5/2018 5:43 AM (GMT -7)
Sr. Sailor,

Yes, I'm a little frustrated (heartbroken?). But, we do count ourselves among the blessed. We were very aware that the study was blinded (and no, our docs don't know what drugs Randy is taking, nor do they know his PSA). Randy is getting the best of medical care, and we're certainly not complaining. Randy has no intention of withdrawing. We both believe that this is important.

That being said, it is hard not knowing. Even so, I don't want to discourage anyone from participating in trials. We'd do it again. This disease is a roller-coaster ride and Friday was a big plunge. We were (as always) hoping for a long holiday from treatment, but it just didn't work out that way. So, forward we go. Randy is scheduled for a Lupron injection on Wednesday and he'll begin taking his "horse pills", again, whatever they are.

I'm grateful for knowledgeable doctors, and the smart folks who develop new treatment options. I'm grateful for the knowledgeable and supportive folks on this site. I truly didn't mean for my little rant to come across as regret. But, I hurt for my husband. He is the best of men.

Donna.
Posted 3/5/2018 6:44 AM (GMT -7)

RandyJoe said...
...and no, our docs don't know what drugs Randy is taking, nor do they know his PSA...

What is the purpose of concealing the PSA level? Concealing the drug regimen makes sense, but it would be difficult for me not to know the PSA. Just curious.

Oh, and you can get PSA done yourself if you want to do so, apart from the study. It's available privately and not very expensive, though if it doesn't affect what you're doing, then it doesn't really matter. It's part of the whole mind-game of this disease and its treatments!

All the best.
55@Dx 4/16/13
Bx: 6/12 pos, G9=5+4 (80%, 60%), 4+5 (2@100%, 80%, 10%), PNI+
cT3a (3T mpMRI: Bilateral EPE, NVB+, SV-, LN-)

Pre:
Date PSA fPSA
9/12 4.1 15%
3/13 5.2 12% PCA3=31

Tx:
IGRT by IMRT, 44 done 8/28/13: 50.4 Gy pelvic nodes, 79.2 Gy prostate
ADT2 3 yrs: Lupron/Casodex, ended 3/16

PSA <0.1 : 8/13 - 5/16;
0.2-8/16, 0.5-12/16, 0.7-3/17, 0.8-5/17, 0.8-7/17, 0.7-10/17, 0.6-1/18
Posted 3/5/2018 6:52 AM (GMT -7)
Redwing,

I'm not sure what the purpose of concealing the PSA might be. It's part of the protocol. Believe me, we've thought about having it tested privately, but we don't want to jeopardize his trial participation.

Donna
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
Posted 3/5/2018 4:36 PM (GMT -7)
RandyJoe,

Sorry for all the questions. Just curious about the study.

Looks like there are 3 arms. One of them is with Xtandi only (no Lupron)...Is that arm blind as well? Just curious how you would have a placebo shot.

When was Randy’s last treatment? How long between treatments...I guess that’s what I’m asking.

Thanks,
Jerry

Post Edited (Jerry L.) : 3/5/2018 4:46:50 PM (GMT-7)

Posted 3/5/2018 5:21 PM (GMT -7)

Jerry L. said...
RandyJoe,

Sorry for all the questions. Just curious about the study.

Looks like there are 3 arms. One of them is with Xtandi only (no Lupron)...Is that arm blind as well? Just curious how you would have a placebo shot.

When was Randy’s last treatment? How long between treatments...I guess that’s what I’m asking.

Thanks,
Jerry


/clinicaltrials.gov/ct2/show/NCT02319837?term=EMBARK&cond=Prostate+Cancer&rank=1

Three arms (all blinded):
Leuprolide + placebo
Leuprolide + enzalutamide
Enzalutamide
Posted 3/5/2018 5:44 PM (GMT -7)
Thanks.

So I’m curious - would they give a fake Lupron shot for that arm? And I wonder what impact Xtandi alone has on Testosterone. If you’re T isn’t impacted, you’d probably know what arm you’re in...
Posted 3/5/2018 5:54 PM (GMT -7)
Jerry L. The Lupron injection is not a placebo. The enzalitamide is either the real thing or a placebo. The only people who know for sure what treatment they are on are the people getting enzalitamide only.
Posted 3/29/2018 5:49 AM (GMT -7)

RandyJoe said...
Jerry L. The Lupron injection is not a placebo. The enzalitamide is either the real thing or a placebo. The only people who know for sure what treatment they are on are the people getting enzalitamide only.

RandyJoe, thanks for your reply to me on another thread about Embark and I have read this thread. I've read about the clinic trial and it says assignment to groups was random. When joining the trial was your husband given the option of just the on-label use Enzalutamide group alone?
Now Age 50, Family Hist
RLP 2012, T2c, 3+4, NX, MX, R2, 4mm Mar., 40% of gland, nerve sparing
PSA 3 months post-op 0.03, 6 mos. 0.03, 9 mos. 0.12
SRT 12/13 w/65Gy
PSA 2/14 to 5/16 0.02, T183
Begin TRT 6/16, PSA 10/16 0.05, T400, PSA 2/17 0.18, T153, Stop TRT 5/17, PSA 6/17 0.53, T200, PSA 10/17 1.53, Axumin PET, CT, Bone Scans Clear 12/17, PSA 1/18 4.0, PSA 3/18 7.3
Posted 3/29/2018 12:29 PM (GMT -7)
Rust,

No, Randy wasn't given a choice. It's totally randomized. Our clinical trial coordinator told us that she didn't know of anyone at Emory who had been randomized to the Enzalutamide-only arm. There is a guy on here who recently began the same trial at Johns Hopkins (?), I think. He is on the Enzalutamide-only arm.

Donna
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
Posted 4/10/2018 6:55 AM (GMT -7)
For those considering applying for entry into the EMBARK study NCT02319837 Enazalutamide (XTandi) and you are located in Alabama, the University of Alabama (UAB) at Birmingham's clinical trial coordinator told me last week that their trial is full and no longer accepting participants. Unless they are offering entry only for their current patients, you will need to find another study location. I will therefore have to commute 250 miles round trip to Atlanta to apply for entry. This doesn't make sense to me and I contacted Pfizer but they referred me back to the UAB clinical trial coordinator.
Now Age 50, Family Hist
RLP 2012, T2c, 3+4, NX, MX, R2, 4mm Mar., 40% of gland, nerve sparing
PSA 3 months post-op 0.03, 6 mos. 0.03, 9 mos. 0.12
SRT 12/13 w/65Gy
PSA 2/14 to 5/16 0.02, T183
Begin TRT 6/16, PSA 10/16 0.05, T400, PSA 2/17 0.18, T153, Stop TRT 5/17, PSA 6/17 0.53, T200, PSA 10/17 1.53, Axumin PET, CT, Bone Scans Clear 12/17, PSA 1/18 4.0, PSA 3/18 7.3
Posted 4/10/2018 7:13 AM (GMT -7)
A generic Zytiga may be coming to market this fall as the Johnson & Johnson patent has been challenged. This might make delaying systemic disease by 3 more years affordable! https://www.fiercepharma.com/marketing/prostate-cancer-shake-up-looms-new-data-from-pfizer-astellas-and-j-j!
Now Age 50, Family Hist
RLP 2012, T2c, 3+4, NX, MX, R2, 4mm Mar., 40% of gland, nerve sparing
PSA 3 months post-op 0.03, 6 mos. 0.03, 9 mos. 0.12
SRT 12/13 w/65Gy
PSA 2/14 to 5/16 0.02, T183
Begin TRT 6/16, PSA 10/16 0.05, T400, PSA 2/17 0.18, T153, Stop TRT 5/17, PSA 6/17 0.53, T200, PSA 10/17 1.53, Axumin PET, CT, Bone Scans Clear 12/17, PSA 1/18 4.0, PSA 3/18 7.3
Posted 4/10/2018 7:30 AM (GMT -7)
I also thank you for participating in this trial, and going through all of this.
PSA 10.9 ~112013
Bx on 112013 at age ~65yrs, with 5 of 12 pos with one G9(5+4), 1 PNI, T2B.
RALP with lymph nodes at Vanderbilt 021914. (nodes clear, SV+, G9 down graded to 4+5, 1 focal margin ) Pros. 106.7 gms!
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
Posted 4/10/2018 7:54 AM (GMT -7)

BillyBob@388 said...
I also thank you for participating in this trial, and going through all of this.

Thanks Billy. I found considerable termite damage at my home 3 weeks ago and have been working feverishly on weekends and took a week of vacation to repair before I go on Lupron and/or XTandi if I get accepted into a trial. I am afraid I will lose my ability to do hard physical labor such as carpentry if I go on ADT. I don't know which is worse, termites or PCa, ha, ha! I vacillate between worrying about them between 2 and 3 AM each night. Then time to get up and go to my 9 to 5 job and stay focused.😊
Now Age 50, Family Hist
RLP 2012, T2c, 3+4, NX, MX, R2, 4mm Mar., 40% of gland, nerve sparing
PSA 3 months post-op 0.03, 6 mos. 0.03, 9 mos. 0.12
SRT 12/13 w/65Gy
PSA 2/14 to 5/16 0.02, T183
Begin TRT 6/16, PSA 10/16 0.05, T400, PSA 2/17 0.18, T153, Stop TRT 5/17, PSA 6/17 0.53, T200, PSA 10/17 1.53, Axumin PET, CT, Bone Scans Clear 12/17, PSA 1/18 4.0, PSA 3/18 7.3
Posted 1/9/2019 7:45 AM (GMT -7)
Update, 9 months into EMBARK trial and no significant side effects from Enzalutamide only trial arm. Some fatigue, lost 10 lbs., increased anxiety and slightly reduced ability to concentrate but overall in good health and have kept up with normal life activities. Now entering 3-month treatment vacation trial phase due to undetectable PSA down from 9 at trial entry. I am now age 51 with BCR out 6 years from IRLP and 5 years out from SRT. PSADT has been 3 months prior to entering EMBARK trial. I am curious how fast my PSA will increase as Enzalutamide blood serum concentration diminishes after 20 days. Previous research shows that 45%+/- of patients treated with Enzalutamide reach PSA of 0.2 or lower after therapy and that therapy was effective in another previous study group on average for 9 to 15 months. The previous study group included those with later stage disease and some who had been on chemotherapy. Researchers are hopeful that some cancer cell death may occur in early BCR patients in a zero testosterone environment (testosterone is still present but cancer cells are unable to absorb it when on Enzalutamide). Enzalutamide is an "androgen receptor (AR) antagonist.
Now Age 50, Family Hist
RLP 2012, T2c, 3+4, NX, MX, R2, 4mm Mar., 40% of gland, nerve sparing
PSA 3 months post-op 0.03, 6 mos. 0.03, 9 mos. 0.12
SRT 12/13 w/65Gy
PSA 2/14 to 5/16 0.02, T183
Begin TRT 6/16, PSA 10/16 0.05, T400, PSA 2/17 0.18, T153, Stop TRT 5/17, PSA 6/17 0.53, T200, PSA 10/17 1.53, Axumin PET, CT, Bone Scans Clear 12/17, PSA 1/18 4.0, PSA 3/18 7.3

Post Edited (Rust) : 1/15/2019 2:13:25 PM (GMT-7)

Posted 1/9/2019 8:33 AM (GMT -7)
Thanks for the update, sounds like things are going as expected!
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 10/1
Posted 1/15/2019 12:19 PM (GMT -7)
Randy's undetectable time after coming off of treatment was about 8 months. After that vacation, he is now on treatment for the duration of the study. No more breaks.
Posted 1/15/2019 2:25 PM (GMT -7)

RandyJoe said...
Randy's undetectable time after coming off of treatment was about 8 months. After that vacation, he is now on treatment for the duration of the study. No more breaks.

Wow, 8 months that is good news and must indicate cancer cell death! I look forward to seeing the next 3-month trial evaluation. After one week off of enzalutamide only trial arm I am feeling slightly different but if it takes 20 days to build up in blood serum to optimal level so I assume it takes about same to depart. Did Randy lose weight?
Now Age 50, Family Hist
RLP 2012, T2c, 3+4, NX, MX, R2, 4mm Mar., 40% of gland, nerve sparing
PSA 3 months post-op 0.03, 6 mos. 0.03, 9 mos. 0.12
SRT 12/13 w/65Gy
PSA 2/14 to 5/16 0.02, T183
Begin TRT 6/16, PSA 10/16 0.05, T400, PSA 2/17 0.18, T153, Stop TRT 5/17, PSA 6/17 0.53, T200, PSA 10/17 1.53, Axumin PET, CT, Bone Scans Clear 12/17, PSA 1/18 4.0, PSA 3/18 7.3
Posted 1/15/2019 2:39 PM (GMT -7)

Jerry L. said...
Thanks.

So I’m curious - would they give a fake Lupron shot for that arm? And I wonder what impact Xtandi alone has on Testosterone. If you’re T isn’t impacted, you’d probably know what arm you’re in...

Enzalutamide monotherapy tripled my testosterone and brought me up to a normalized level of 570 as body tries to compensate for the AR antagonist.
Now Age 50, Family Hist
RLP 2012, T2c, 3+4, NX, MX, R2, 4mm Mar., 40% of gland, nerve sparing
PSA 3 months post-op 0.03, 6 mos. 0.03, 9 mos. 0.12
SRT 12/13 w/65Gy
PSA 2/14 to 5/16 0.02, T183
Begin TRT 6/16, PSA 10/16 0.05, T400, PSA 2/17 0.18, T153, Stop TRT 5/17, PSA 6/17 0.53, T200, PSA 10/17 1.53, Axumin PET, CT, Bone Scans Clear 12/17, PSA 1/18 4.0, PSA 3/18 7.3
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