Patients Personal Experience
Introduction - Jack Beaven
This is the experience Jack Beaven had
with Provenge. He unfortunately started out with the placebo, but eventually
did receive the vaccine which by that time, did not do him any good.
One aspect of clinical trials that is
seldom reported is what happens to the patient once the trial is concluded. In
this case, the patient started on a treatment that he had previously
Sent: Friday, July 05, 2002 4:42 PM
Subject: [hrpca] Dendreon/Provenge trial
Here is my experience to date with the Phase III trial
for Dendreon's Provenge vaccine based on my own dendritic cells.
I was accepted for trial participation in December,
2001 and had baseline tests on December 27 & 28. The "therapy" phase
(described at the above site) began on 1/8/02 and was completed on 2/7/02.
||last local test before starting
trial - up from 34.5 on 10/15
||"No evidence of recurrent or
"Intense increased uptake is seen in the left
scapula. It is extremely hot." Other "moderately intense uptake"
areas noted. Also
noted that which might be degenerative or metastatic.
|Covance CLS -- the trial lab.
(Difference probably due to differing lab assays.)
"Interval improvement of several of the areas of
increased activity since previous exam of 12/27 suggesting interval
improvement in the metastatic disease. No new areas identified to
||PSA 125.8, PAP 5.8
||Covance CLS lab
Compared to the prior study of 2/28/02, the current
study shows increased tracer activity in the left scapula and at T7.
These may represent disease progression or due to chemotherapy flair
(if chemo received within 3-6 months). There are no new focal
abnormalities that are suspicious for metastatic disease. [I'm assuming
the "chemo" to be the vaccine infusions. /jb]
Next bone scan will be Monday, 7/8/02. I will probably
have the report within a couple of weeks after that, if I bug them
Dendreon doesn't rely on PSA as a marker, but only
progression as shown by scans and (I guess) other indicators. In
fact, they said that the PSA would rise initially because the immune system
activity would mean many dead cancer cells (with PSA) would be
circulating in the blood and thus show up on tests.
Because our local lab showed a higher PSA than the
Covance base line, I consider that the latest local PSA being 20%
lower than the Covance May PSA to be a positive sign. Physically, I
still feel fine with no actual pain and no discomfort that I can
attribute to cancer.
Technically, I don't really know whether I received the
real vaccine or a placebo, but I think it must have been the real stuff.
FWIW, I understand that of the trial participants at
the Columbus, OH test site, I was the 2nd to show any regression (which may
now have turned around since then), but several had shown stability.
My tea tag this afternoon reads: "What is wrong for
one person may be
right for another."
Update of February 2003, after the double blind was
Sent: Friday, February 28, 2003 6:44 PM
Well, after a year of follow up bone scans, Dendreon has finally broken the
blind. I was on the "placebo" arm, so it's back to square one.
I am entered in the supplementary trial that is offered to those who
received the placebo. The immature dendritic cells that were harvested from
me in Jan/Feb 2002 were frozen and saved, and now will be used to produce
the "real" vaccine. I will be infused on 3/5/03, 3/19/03, and 4/2/03 and the
first follow up bone scan will probably be in mid-May.
Everything I previously posted concerning trial procedures is still valid,
but the bone scan data is only applicable to the placebo arm.
Since Provenge - update to 6/10/2004.
My experience with a phase III trial of Provenge has been covered
elsewhere on this page. This is intended to document my status after
leaving the clinical trial.
Briefly: A participant has his immature dendritic cells harvested and
the vaccine prepared using them infused two days later on weeks one,
three, and five. That completes the treatment phase. Follow-up is by
bone scan and/or CT scan about every 8 weeks, depending upon where
metastases were found on baseline scans.
After about a year on the program, the blind was broken, and I
discovered I had received the placebo, and then enrolled on the
secondary trial where I received the real vaccine prepared from my cells
that had been frozen and saved. My first bone scan (no CT scans have
ever shown soft tissue involvement) following this follow-on
(cross-over) treatment phase was on 4/30/03.
On 5/28/03 at a follow up appointment with the trial site's urologist
to discuss the bone scan, I asked if he had ever seen anyone on the
trial in my situation (i.e., progression after receiving the actual
vaccine in a follow-up trial) who then achieves regression or even
stability. He answered that he had not. In effect, I was off the trial.
I had a scheduled appointment with my medical oncologist on June 19th
at which time we discussed options for my next treatment. (Previous
treatments were RRP 5/28/92, hormone therapy '93-'96, 2nd line hormone
treatments - aminoglutethimide + cortef 5/97-4/00, and experiments with
PC-SPES, GCP/AHCC, and the rife-bare frequency generator. During all
this time and to the present I continued with Lupron.)
By the time I had base line tests for the Provenge trial, my PSA had
risen to 44.1. Coming out of the follow-up trial, it had risen to 309.1.
I suggested to my oncologist that we might re-try the aminoglutethimide
+ cortef, which had worked for me in the past. Before making any
decisions, she wanted to start me on Zometa, which we did. First
infusion was on 6/24/03. Because of an intervening vacation, 2nd Zometa
infusion was on 8/12/03, at which time the PSA had dropped to 190.2.
At that time I re-started the aminoglutethimide + cortef, which has
continued from then on, along with 3-mo Lupron shots and monthly Zometa
My PSA has bounced around quite a bit over this time:
Despite these high numbers, I still feel physically OK. I do have
metastases, but cannot identify any pain or discomfort caused by them.
The only pain medication I take is Celebrex, and because of a goof-up I
was without it for about 3 days. I did experience some minor pain during
this time, but it went away as soon as I was able to take the Celebrex
again, making me think it was arthritic in origin rather than from PCa.
The impression reported on my latest bone scan in January was of
"fairly stable metastatic disease."
So, something's going on, but my QOL is pretty darn good, all things
considered. I'm able to exercise regularly with tennis and table tennis,
my appetite is (too) good, and my GP said today that all my vital signs
Over the years I have avoided radiation, and I'm hoping to postpone
chemo for as long as possible. After all, maybe one of the trials on
immune system, gene, anti-angiogenesis, etc. therapies will prove out
and provide, if not a cure, at least positive control with few or no
side effects. (BTW, I had zero side effects from the Provenge vaccine)
Since Provenge Part II - Update dated 5/18/2005.
In the fall of 2001 I learned about Dendreon's Phase III trial of
Provenge. It came at the right time for me. After three years of holding
my PCa in check, Cytadren showed signs of losing effectiveness, and I
had tried PC-SPES (I knew several men personally who'd had good success
with this) as well as AHCC and GCP. None of these seemed to do me any
good, so I interviewed for the trial and was accepted.
I was willing to go on the trial because I was feeling pretty good
physically, and if I was put on the placebo (33% chance) and progressed,
I would be able to get the "real" vaccine made up from my cells that
would be saved for the purpose.
12/18/01 PSA 44.1 (by my oncologist)
During the trial I continued on Lupron, but had no other treatment
from my oncologist in Dayton)
Baseline for trial (Ohio site is Riverside Methodist Hospital in
12/27/01 PSA 42.8 (Covance: the trial lab)
BONE SCAN: 2 metastatic lesions, one on left scapula (which I had
since 1/93), and one at T7
CT & X-rays: no evidence of soft tissue involvement. Therefore,
during the trial I would just have bonescan follow ups, and blood tests
(but only rarely for PSA -- Dendreon relies mainly on the scans)
2/19/02 PSA 47.7 (Dayton)
2/28: -- 1st follow up tests after receiving the vaccine (or
BONE SCAN: "No new areas noted to indicate progression"
4/23 PSA 70.2
5/15 BONE SCAN: "Increased activity in two areas previously
PSA 125.8 (Covance)
6/25: PSA 98.3 (Dayton)
7/8: BONE SCAN "Improvement in left scapula; no change in T7"
8/27: PSA 135.5 (Dayton)
9/4: BONE SCAN "Progression in left scapula; T7 stable; new lesion @
left 9th rib"
PSA 179.0 (Covance)
11/25: BONE SCAN "Previously noted lesions probably represent stable
metastatic disease; new focus in right scapula or underlying right 6th
12/10: PSA 190.6 (Dayton)
2/10/03: BONE SCAN "Left scapula, T7, and new focus on 4th posterior
rib, probably metastatic." Dendreon broke blind, and I found I did
receive the placebo. This bone scan was then used for a new baseline.
2/14: PSA 319.5 (Covance -- new PSA baseline)
3/11: PSA 249.8 (Dayton)
4/30: BONE SCAN for follow-up trial after receiving vaccine. "Avid
uptake at left scapula, T7, 4th rib, right scapula or underlying right
6th rib, plus new spots at right 9th rib and T3." This represented
progression after receiving actual vaccine, and ended my participation
in the trial.
We had a couple of previously scheduled trips to Colorado and
Gatlinburg, so I didn't see my oncologist again until June 17. We had
discussed my returning to Cytadren, which might work again after a 2
year layoff (a principle I learned from the HRPC list). She wanted me to
hold off for a bit, and started me on Zometa along with continuing
6/17: PSA 309.1
6/24: First Zometa infusion
8/10: PSA 190.2 9/15: PSA 243.2 10/13: PSA 339.8
10/24: BONE SCAN Uptakes noted on left & right scapula, T7, C5, 4th
posterior rib on right, & right
9th rib. Slight progression noted when compared to previous (Dayton)
scan on 4/23/01.
11/10: PSA 316.3 12/11: PSA 290.6
12/16: Re-start Cytadren + Hydrocortisone
1/8/04: PSA 453.7 2/23: PSA 302.9 4/7: PSA 393.5 5/10: PSA 355.5
6/7: PSA 268.3 7/6: PSA 302.8
8/10: PSA 184.0 BONE SCAN (Pretty much a repeat of 10/24 except no
mention of 4th & 9th ribs)
9/7: PSA 113.2 10/5: 320.2 11/1: PSA 248.7 12/7: PSA 206.5
1/4/05: PSA 309.5
2/3: BONE SCAN Widespread metastatic disease with some progression.
2/8: PSA 362.9 This is where we decided to stop the Cytadren. My
objective was, as always, to try the least aggressive treatment that
might work, and maybe DES would fit. List members were very helpful in
providing guidance in seeking a compounding pharmacist, and this
information helped me find 3 potential local sources. If none of these
work out, there are also others that list members have had actual
experience with. Thank you!
I did stop the Cytadren right away, but had to taper off the
hydrocortisone over six weeks. I know I could have done it faster, but
decided to follow my oncologist's schedule. We were off for a month in
Florida, anyway, and I had cataract surgery scheduled for April 8 on our
On April 12 my PSA was actually down to 261.1 -- with no treatment
except continuing Lupron, not even the Zometa, since February 10. Zometa
was resumed on 4/14.
On May 10, my PSA again, to 167.3. My next PSA will be on June 7, so
I will have results by the time we get to the conference.
I know that my approach will seem quite leisurely to many on this
list, but my QOL is quite good, I would say about 85-90% for someone in
my age group. I'm not taking any pain medication (except my daily 81mg
aspirin, and Celebrex, which I'm really doing for whatever anti-cancer
activity it may have), I'm able to play tennis and table tennis
regularly, and of course I'm tailoring my nutrition & supplements pretty
much along Myers guidelines. Plus I have upbeat music on most all of the
time at home -- particularly the Traditional Jazz that I'm addicted to,
and we find reasons to laugh a lot.
My tea tag today says: "The man who removes a mountain begins by
carrying away small stones."
Best to all,
Jack M. Beaven
Dayton, Ohio 12 year PCa