THERE WAS NO RESPONSE TO AN UPDATE REMINDER IN 2016 SO THERE IS NO UPDATE.

It all started for me at the young age of 55, happily married for 34 yrs with four wonderful children...

My philosophy in life was "if it ain't broke don't fix it", even when it came to doctor visits and physicals (turned out to be a poor philosophy)!

From early 2011 to Oct 2012, I was experiencing some classic symptoms of an enlarged prostate (BPH). Then out of the blue, while at work, I got a severe pain between my pelvic and hip. I was totally convinced that I sprained a muscle and began some home remedies, like pectin (which appeared to be helping).

In Dec 2012, with some strong encouragement from my wife, I had my first physical in 20 yrs, which included a DRE, and my first ever PSA test.

DRE confirmed an enlarged prostate, but "age appropriate", but my PSA test came back at 84.7ng/ml. After a quick referral and visit to a local Urologist, it was a no brain'er for my needing a biopsy.

Biopsy found 12 of 12 cores positive for cancer, with a Gleason Score of 9 (4+5). Started on 50mg of Casodex (Bicalutamide) and was scheduled for CAT/Bone Scans.

Scans results showed that the cancer had spread to my hips, spine, ribs and pelvic area. I have a Stage IV aggressive cancer (T4N1M1b)

Needless to say, such a diagnosis is quite a shock to yourself and your loved ones. Family members were told shortly after getting my high PSA results and the cancer outlook. I especially wanted to warn my brothers about the need for thier PSA screening. After much sole searching, I decided that it was best mentally for me, and possibly for the benefit of others, to share my condition with my co-workers.

I started Hormone Therapy (HT), getting a 3mo. regimen of Lupron shots, while continuing the 50mg Casodex pill. I went to Sloan-Kettering to get a second opinion from both a medical and radiation oncologist. Sloan agreed with the diagnosis, biopsy pathology and HT treatment plan.

After just a couple of weeks post 1st Lupron shot, my hip pain began to disappear. Within 2 months the pain was 98% gone, and PSA had dropped from a high of 101 to .8, this was all a pleasent surprise!

So far the only side effects I've experienced from the medications is some fatigue, minor muscle aches and hot flushes. A decent trade for the benefits I'm getting.

PSA History to date: 12/24/2012=84.7, 01/28/2013=101.0, 02/20/2013=98.7, 4/25/2013=0.8, 06/04/13=0.2, 07/03/13=0.3

Living for the moment and hoping that the success on HT is a long one...

Update 10/1/2013: Since my July status, I have had a few more PSA tests: Aug. was up to 0.8 (from 0.3) and Sept. was up to 1.3. I am hoping this is a normal PSA bounce and we will start to see the numbers level off, or better yet, go back down.

I started having some knee pain this past month, with the left knee having the most pain. Got a second set of bone and CT scans. Bone scans show no new lesions on the bones, and the previous identified spots showed some reduction in intensity. There was a new spot on the bone scan, on left knee, but a subsequent MRI of the knee did not support it being cancer, so we will treat it as a possible arthritic condition. The CT scan also showed some reduction in the tumors.

The opinion from my Medical Oncologist is that although the PSA's are shows a minor increase, all other indications are that I'm getting a good response from the Hormone Therapy (HT). So for now, we'll stick with HT, and get another PSA check towards the end of October.

PSA trends to date: 12/24/2012=84.7, 01/28/2013=101.0, 02/20=98.7, 4/25=0.8, 06/04=0.2, 07/03=0.3, 08/04=0.8, 08/29=1.3

The last 3 months have been quite busy, not only with the Holidays, but with making some major decisions on the next type of treatment.

PSA had been steadily climbing since my low of 0.2 in June of 2013; pretty much doubling every month since. When it got up to 3.4 by the end of October it was quite clear that the first line hormone therapy was beginning to fail. For my particular case, I would consider that I got anywhere from 5 to 6 months from the Lupron/Casodex hormonal therapy.

On 11/20/13 we decided to stop taking the Casodex (Bicalutamide) drug, as some percentage of people have a positive response by doing so. I was not one of the lucky ones to get such a positive response and by 12/11 my PSA was up to 13.0 and the latest one on 01/7/2014 was up to 35.

Although I had every intention of making PROVENGE® (sipuleucel-T) my next therapy, some other options presented themselves that needed to be considered. One of those options was to get an appointment set-up with a Prostate Cancer specialist in Virginia, a Dr. Charles Myers; an appointment was set for Jan 10, 2014.

In addition to the appointment with Dr. Myers, I also began looking into a clinical trial at the National Institutes of Health (NIH). The trial number at NIH is #3-C-0146 and trial ID is #NCT01867333. It is a randomized Phase II trial that is combining a vaccine therapy (PROSTVAC /TRICOM) and Enzalutamide (Xtandi) vs. Enzalutamide (Xtandi) alone.

I enrolled in the trial on Jan 7 and was randomized into the arm of the trial that includes both the vaccine and Xtandi. Received my first vaccine injection, and Xtandi pills, on the same day as my enrollment. Three days later I had my initial consult with Dr. Myers and during the visit he spoke very highly of the NIH trial and my participation in it. He told me that Xtandi would have been his first choice of next treatment for my cancer, and felt the vaccine is a bonus.

There were some very frustrating delays getting up to this point; I had to be off the Casodex drug for a minimum of 6 weeks, before being able to start on the NIH trial, and getting an appointment with Dr. Myers took almost 2 month (granted that included the Nov/Dec holidays).

Although I wish things could have happened a little faster, I'm very pleased with the end results. I'm excited to be taking part in the clinical trial and am very happy to have my overall health monitored by a renowned Prostate Cancer specialist (Dr. Myers).

PSA trends to date: 12/24/2012=84.7, 01/28/2013=101.0, 02/20=98.7, 4/25=0.8, 06/04=0.2, 07/03=0.3, 08/04=0.8, 08/29=1.3, 10/21=3.4, 11/11=6.2, 12/11=13, 12/20=21.57, 1/7/14=35

Two weeks after starting the Xtandi & Prostvac trial, I developed a rash that was pretty much showing up all over my entire body. There was no pain or itching associated with this rash, but apparently it was an uncommon side effect of the trial meds, and caused some concern for the trial team at NIH.

I was scheduled to get my second two week vaccine shot and lab tests, but because of the rash, I was admitted into the NIH hospital (in isolation) to examine the rash. NIH's trial team, dermatology, and infectious disease experts did a thorough examination of the rash, and by the end of the day they concluded that it was just a drug reaction (not a virus). Since the rash had started to diminish from the day before, they believed my immune system was doing what it is suppose to do, and was dealing with the new meds, so I was allowed to continue with the trial without any interruption. I was very happy to hear that news and have since received my third vaccine shot and lab tests on 2/4/14.

The side effects from Xtandi/Prostvac med have been quite minimal. The second shot (in the leg) caused localized pain for a few days, similar to being punched in the leg (aka Charlie Horse). The third shot caused a similar pain, but went away in just a day.

My first PSA's since starting the trial dropped and the next one went back up a little. Not too concerned about the numbers at this point, seeing that I am feeling better than I have in the past 4 months. Dr. Myers mentioned that he has seen a PSA flare effect with some of his patients starting Xtandi, maybe the cancer cells dying off?

I must mention that the staff and quality of care provided by NIH has been absolutely wonderful. Although it's a 5 to 6 hour drive to NIH, and the winter weather has not been all that cooperative, the payback has been terrific. Hoping this combination of these two new therapies provides for a long lasting remission.

PSA trends to date: 12/24/2012=84.7, 01/28/2013=101.0, 2/7 start casodex, 02/20=98.7 start Lupron, 4/25=0.8, 06/04=0.2 (nadir), 07/03=0.3, 08/04=0.8, 08/29=1.3, 10/21=3.4, 11/11=6.2, 11/25 stop casodex, 12/11=13, 12/20=21.57, 1/7/14=35.45 start xtandi wvaccine trial, 1/21=28.58, 2/4=32.06

Not so good news; got my 3 month ct/bone scans and blood tests at NIH and my PSA is still rising, scans show new lesions on kidney, liver and shoulder. I am also having problems with swelling of my right foot/ankle, with some pain in the right pelvic/leg, which is apparently being caused by cancer growth of the pelvic lymph node and pinching off of blood flow to the right leg.

The team at NIH felt that due to disease progression, it was in my best interest to withdraw from the trial. I knew when starting the trial that some people simply do not respond to Xtandi and it appears I fall into that group. As for the Vaccine component of the trial; this was intended to provide a long term immune system response, so even though the Xtandi did not work, there is some possibility that the vaccine effects will continue to support the next treatment.

NIH has offered that I join a study of the combining Cabozantinib (XL184) plus Docetaxel and Prednisone, which I am considering, but this will require a 29day "wash out" of the current drugs. I am currently requesting Dr. Myers opinion on the treatment being offered.

There are still a number of hopeful treatment options available, just having to decide on one much earlier than expected.

PSA trends to date: 12/24/2012=84.7, 01/28/2013=101.0, 2/7 start casodex, 02/20=98.7 start Lupron, 4/25=0.8, 06/04=0.2 (nadir), 07/03=0.3, 08/04=0.8, 08/29=1.3, 10/21=3.4, 11/11=6.2, 11/25 stop casodex, 12/11=13, 12/20=21.57, 1/7/14=35.45 start xtandi wvaccine trial, 1/21=28.58,2/4=32.06, 3/4=37.16, 4/1=48.64

Met with Dr Myers and he said that because of cancer involvement of the liver and adrenal gland, I needed some rapid and extensive tumor kill, and that joining the NIH study would be prudent. In addition to this NIH study he will begin formulating a plan B treatment, should the Docetaxel (chemo) and XL-184 treatment not produce the results needed. The NIH treatments will begin on April 29th.

PSA trends to date: 12/24/2012=84.7, 01/28/2013=101.0, 2/7 start casodex, 02/20=98.7 start Lupron, 4/25=0.8, 06/04=0.2 (nadir), 07/03=0.3, 08/04=0.8, 08/29=1.3, 10/21=3.4, 11/11=6.2, 11/25 stop casodex, 12/11=13, 12/20=21.57, 1/7/14=35.45 start xtandi wvaccine trial, 1/21=28.58,2/4=32.06, 3/4=37.16, 4/1=48.64 off xtandi trial, 4/14=60.86

Started the NIH study trial of Docetaxel with Prednisone and XL-184 (cabozantinib), and just received my second cycle of Docetaxel. The Prednisone and XL-184 pills are taken daily, and the Docetaxel (chemo) is IV dripped every 3 weeks. Two weeks after the 1st cycle of chemo I started getting some decent relief with the swelling of the right leg and improved leg lift strength. About this same time I also started noticing significant hair loss, which has continued for the past two weeks. Have also lost most of my taste buds, so pretty much all food tastes like cardboard, which I understand s a common side effect of the chemo. I have not experienced any nausea yet and so far only minimal fatigue. Having some sensitivity / numbness of the fingertips, which is a common side effect of the XL-184.

I'm encouraged to see my PSA drop, but had been advised by Dr Myers that even if it went up, it would not have meant that the treatment was not working. A series of scans are scheduled for the end of June, so for now, physical symptoms will be the only indications of treatments effectiveness.

PSA trends to date: 12/24/2012=84.7, 01/28/2013=101.0, 2/7 start casodex, 02/20=98.7 start Lupron, 4/25=0.8, 06/04=0.2 (nadir), 07/03=0.3, 08/04=0.8, 08/29=1.3, 10/21=3.4, 11/11=6.2, 11/25 stop casodex, 12/11=13, 12/20=21.57, 1/7/14=35.45 start xtandi wvaccine trial, 1/21=28.58,2/4=32.06, 3/4=37.16, 4/1=48.64, off xtandi trial, 4/14=60.86, 5/1=80.05 started chemo/XL184 trial, 5/19=54.19

Got my 3 month chemo/xl184 trial scans today and things are going in the right direction. PSA dropped to 18.2, CT scans show tumor reduction size at pretty much all soft tissue locations. Bone scan results were mixed, with some uptick on the left hip area, but due to all other indications (with how good I feel being included), they strongly suspect I'm seeing a early treatment flare effect on the scans, which may not be indicating an increase in the cancer. Apparently this flare is not that uncommon for someone,shortly after starting chemo.

Side effects over the past month:

1. Had a short episode of my right foot burning, which is a side effect of the xl184. Felt like I burnt my heel and big toe in the hot sand, but had no blistering. It was quite uncomfortable to walk for a few days though.I kept applying the lotions prescribed and my feet a feeling quite good for now.
2. Have had 4 or 5 ten minute long episodes of severe hand and feet cramps, Hands cramp up into a fist and is quite painful, and are impossible to open them. Not a common side effect of either med, but the clinic has observed this in other patients on the trial. Nothing in the blood work to indicate a reason, suggested hydration.
3. Hair has stopped falling out, but is quite thin,and I can see my scalp (this is from chemo). Color of what's left, has turned white (was salt and pepper, heavy on the salt) and this I believe is from the xl184.
4. Fatigue is starting to kick up a notch, where sometimes a extended stair climb can be exhausting. Exercise is suppose to help combat that, so back to the treadmill...both meds can cause this.
5. Low PSA, no pain, improved scans; I'm happy to take these over the other rather minor discomforts!

Overall, I'm very happy with the direction that this trial is taking things.

PSA trends to date: 12/24/2012=84.7, 01/28/2013=101.0, 2/7 start casodex, 02/20=98.7 start Lupron, 4/25=0.8, 06/04=0.2 (nadir), 07/03=0.3, 08/04=0.8, 08/29=1.3, 10/21=3.4, 11/11=6.2, 11/25 stop casodex, 12/11=13, 12/20=21.57, 1/7/14=35.45 start xtandi wvaccine trial, 1/21=28.58,2/4=32.06, 3/4=37.16, 4/1=48.64, off xtandi trial, 4/14=60.86, 5/1=80.05 started chemo/XL184 trial, 5/19=54.19, 6/9=34.58, 6/30=18.2

Got my 5th chemo cycle, PSA has now dropped to 12.4 (from 18.2), so still moving in the right direction, and all other blood tests look normal. Tried chomping on ice during the infusion, to see if it helps with the taste buds, but the jury is still out on that. During the past 3 weeks noticed having very frequent heart burn and a dry cough. The docs said that both are likely a side effect (SE) from the prednisone (steroids), so they prescribe some Zantac to add to the mix of drugs.

Getting a little tricky taking these meds as the XL-184 has to be taken on an empty stomach, nothing to eat 2hrs before or one hour after and now since the Zantac can interfere with XL-184, have to take that no less than 4 hours after the XL-184 and at least 14hrs before. It's not so bad during the work week, with regularly scheduled meals, however weekend food consumption times can tend to be more unpredictable for us.

Overall I'm still very pleased with the results achieved from this protocol and consider the SE's to be minimal.

8/19/14 - Had more more blood testing done and received my 6th chemo cycle. My feet had been burning for the past three weeks and the doc's were concerned about their condition. They discussed reducing the XL-184 to 20mg (from 40mg), but once they do that, the trial will not allow a patient to go back to 40mg if things should clear up. I told them I would prefer to stay at 40mg., and if they get worse, we can discuss a reduction (so far the pain is tolerable). Not everybody experiences this burning feet SE from the XL-184, and the nurse that I see at NIH said that I am the only patient she has on the trial who is having this issue.

The only new side effect has been a few instances of diarrhea, which must be quite common, because the nurse has been asking since day one of the trial, if I have had experienced this problem; a few Imodium are all that is needed.

My latest PSA test came back at 8.67, down from 12.14! Some other interesting test results have been with my Alkaline Phosphatase; at start of trial it was 178U/L and is now 88U/L (normal is 40-130 U/L) and my Bone Specific Alkaline Phosphatase have gone from 46mcg/L to 15mcg/L (normal range is 0-20mcg/L). Both of these number are important, since some studies have shown a correlation between higher Phosphatase numbers and bone cancer activity.

It would appear that for the moment we have the cancer doing some back peddling. I hope these positive indications are soon backed up by the scans that I will have the second week of Sept.

Completed 7th chemo cycle. PSA is down to 6.6 from 8.67, CT Scans showed some reduction in lymph nodes, and bones scans were stable with no new lesions. The trial doc was very please with my test results and sincerely believes the combination of these two drugs are providing me with better results than either drug would individually.

The fatigue following the last chemo cycle was actually less than the prior one. Feet burning is still a problem that comes and goes, and also had some minor hand burns this past month. These burns can be uncomfortable and seems to be worst the week following the chemo cycle.

I have no new SE's, but do have one that I never recognized until I started viewing photos of my son's wedding... not only is my hair very thin and white, but my skin color is also quite washed out. The docs at NIH confirmed that this skin pigment change was being caused by the trial drugs.

Bottom line is that the results are still favorable and I will continue on the trial for at least another 9 weeks (until the next scans), getting tests and chemo every 3 weeks.

Been busy and skipped a few updates... 10 days after my 7th chemo cycle I had a episode that required a hospital stay. I was determined to be Neutropenic, where my neutrophil count had dropped to 100 and at 500

Sept. 30 - I had my 8th chemo treatment. Since I had experienced the low nuetrophil count following my previous chemo cycle, NIH gave me pegfilgrastim (Neulasta), in a prefilled syringe, for me to self administer 24hrs post-chemo treatments. I was pleased to see my PSA drop a little more; down to 6.01 from 6.6 this visit. The doc's however did not like the looks of my feet sores at all, and after some considerable thought, they asked that I stop taking the XL-184 pills to see if that would help clear things up. After being off the XL-184 for an entire week, my feet and hands improved considerably, and I was allowed to resume the XL-184 at the normal trial dosage of 40mg/day.

Oct 21 - I had my 9th chemo treatment. My PSA actually went up a tad this visit, from 6.01. to 6.49; not sure how to take this small rise, the nurse who treats many other patient on chemo said she's seen this happen in other patients, so I'm not too worried just yet. I asked the doc if he thought my PSA rise could be associated with being off the XL-184 for the one week, but he did not believe so, and was not concerned about the number at all. They did observe, for a second time, a high blood glucose reading and said that they may include an A1C check on my next visit (I should have passed on the Mocha Frappe on my trip down to NIH).

Mid-Nov I'll get another PSA, set of scans and chemo#10, so that visit should be interesting.

I'm feeling good, going to work every day, and am having no hand or foot pain, so interestingly I continue to benefit from that 1 week vacation from the XL-184.

Since my last update I've have had Chemo cycles 10 thru 12, with the 12^th one being two days before Christmas.

PSA's continued to go up with each 3 week visit; from the 6.49 to: 11/12=7.49, 12/2=8.06, 12/23=10.74 and 1/12/15=14.26. This is obviously a concerning trend, but the scans, including the latest on 1/12, still show stable disease, with maybe some minor increase in the pelvic lymph nodes, but not significant enough to exit the clinical trial.

Have had some complications lately as I developed as pneumonia, and on Christmas eve was admitted to the hospital due to a 5cm abscess on the lung. Because of this abscess I went off the XL-184 for 3weeks, and my last visit to NIH on the 12^th, we skipped the chemo. I have restarted XL-184 at a lower dose (20mg vs 40mg), which keeps me eligible to stay on the trial. Will probably skip chemo at my next 3week visit, with the possibility of starting back up in 6weeks (assuming the abscess clears up).

Biggest issue I'm dealing with right now is legs swelling and some significant pain in the right leg, which we suspect it tied to the pelvic lymph node increase. I'm working with a physical therapist specialized in treatment of "lymphodemia". Hopefully that will help some, because the current pain meds just aren't cutting it.

For the near term I will continue on the clinical trial, but indications are that the cancer has become resistant to the current chemo/xl-184 therapy, so it is time to look for the "what next" options.

My mind has been so occupied over the last two months with trying to figure out what my next best treatment might be, that I've had little mind to update here. Since my last update I have received chemo #13 and #14 and my PSA's have continued to rise, reaching into the high 20's / mid 30's. The swelling in my right leg has actually decreased quite a bit, while the left leg is now swelling worse than the right ever did. I enjoyed my taste buds coming back during the chemo/xl184 break; unfortunately taste once again is slipping away.

I just received notice from NIH that the scans taken on Mar 17th showed two new lesions, one in the pelvic bone and one on the shoulder blade. Per the trial protocol these spots constitute disease progression and an end to my participation in the docetaxel/XL184 trial. There were no other trials currently available at NIH, that were appropriate for the aggressive nature of my cancer.

Recognizing the likelihood that some of my cancer had become resistant to Docetaxel, I had already begun looking for another plan B. With the support of a friend whom was also diagnosed two years ago with similar stats as mine, and today reports being cancer free, I initiated a new plan that includes shifting my treatment to some doctors at the Mayo Clinic and Minnesota Oncology. These doctors are known to treat more aggressively, with curative intent vs. a palliative standard of care, which is difficult to find.

I obtained a Choline-Pet Scan at Mayo, which produced some scary images, and lead to some additional blood testing, as well as a kidney and brain MRI's. Those tests showed good liver and kidney function, and yes there is a brain; and with no cancer! These images will provide a great baseline for determining the effectiveness of next line of treatments.

The Minnesota oncologist recommended that I receive 3 cycles (one treatment every three week), of Jevtana (Cabazitaxel) locally, which is a standard FDA approved chemo treatment. Two weeks after the 3rd treatment, I will be re-scanned at Mayo in order to determine if any cancer cells are not responding to Jevtana. If there are some rogue cells remaining, I'm hoping we can add some other form of treatment that will wipe them out!

I've had some struggles the past two months... Went into the hospital with back pain (felt like a kidney stone passing). CT scans showed both kidneys being enlarged and blood tests indicated the kidneys were stressed. My urologist decided it was necessary to place a stents from the kidney to the bladder to get by the blockage (cancer?). During the procedure the urologist was able place a stent in the right kidney, but could not place one in the left kidney due to obstruction. In order to keep the left kidney healthy, a nephrostomy tube was placed in that kidney (kidney fluid drains into an external bag).

About a week after the kidney hospital visit I had to return to the emergency room due to dangerously low blood pressure. The doctors believe this was caused by the combination of my third chemo treatment and a urinary infection. Treated for infection and BP, then released.

Then, about a week after the blood pressure visit, I noticed that was not urinating at all. It was pretty obvious to me that the stent in the right kidney must be blocked, since that was the only kidney dumping into the bladder. Back to the hospital, confirmed the blockage, had to place a nephrostomy tube in the right kidney. Both kidneys are now draining into a nephrostomy tube.

All of this has caused me to become quite weak and miss a considerable amount of work due to visits, weakness and general discomfort.

Where do I stand on the cancer... Received 3 cycles of Jevtana (chemo) and never saw a real response via PSA, pretty much held at around 30. No improvement in symptoms either.

Went to Mayo for another set of scans and they showed that the cancer is advancing in a number of areas, one being at the left supraclavicular lymph node, which they wanted to biopsy, but could not until I was off my blood thinner for at least 48hrs. Mayo also believed I had considerable fluid in one of my lungs, which they wanted to drain and test, but again could not due to blood thinner. Came home with orders to have the biopsy and lung drained locally, which we are working on. PSA taken at Mayo visit was 45.

The tumor biopsy is necessary to determine if the progressing cancer is small cell or not, which will help determine the next best treatment. My local oncologist did not want to do any more Jevtana cycles, until we have the biopsy results.

I'm definitely having my most physically challenging time since diagnosis. I can only comfortably walk about 20-50 feet without rest, and have considerable pain in pelvic and back areas, which does not respond well to pain killers.

Still hoping that I can get started soon on some form of treatment that will be effective on my cancer.

Don's e-mail address is: dwries AT gmail.com (replace "AT" with "@")

NOTE: Don has not updated his story for more than 15 months, so you may not receive any response from him.