Free Clinical Trials in the USA and Canada (hope it is ok to post this)

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6071
Regular Member


Date Joined Jul 2008
Total Posts : 113
   Posted 6/2/2010 4:20 PM (GMT -6)   
 

Free Clinical Trials in the USA and Canada
hope it is ok to post this
http://cancerforums.net/about17824.html
Primary Prostate Cancer Clinical Trial in the USA and Canada:
High intensity focused ultrasound (HIFU) is a non-invasive acoustic ablation technique that uses intersecting, precision focused ultrasound waves to raise the temperature of the target to) 80-90 degrees C in 2-3 seconds, destroying the targeted tissues (prostate cancer). The tissue targeting is highly precise, minimizing collateral damage.
The overall hypothesis is that HIFU with Sonablate can safely, effectively and selectively ablate prostate cancer tissue, resulting in complete tissue necrosis, in patients diagnosed with localized T1c/T2a prostate cancer, with minimal morbidity.
The specific hypothesis is that the Sonablate has the ability to:
Completely destroy prostate cancer tissue, without causing damage to the intervening tissue, with a drop in PSA levels to <0.5ng/ml.
Result in negative biopsies for evidence of viable malignant cells after the treatment (12 months if Nadir is not reached or PSA rises from Nadir)
Safely treat localized prostate cancer patients, with minimal and acceptable adverse effects
Eligibility—to be considered for the U.S. primary trials, candidates must:
have T1c or T2c carcinoma of the prostate detected by biopsy;
be between 40-75 years of age;
have a Gleason score of six or less;
have prostate specific antigen (PSA) level of 10 ng/mL or less.
volumn of 40cm or less
locations in the USA:
Birmingham, AL
Naples, FL
Myrtle Beach, SC
Nashville, TN
Memphis, TN
San Antonio, TX
Madison, WI
(BTW, I think that Texas and Tennessee's trials are full, but phone to find out for sure.)
There is no cost to enroll in the study, nor does it require health insurance. To learn if you qualify, please contact us at 1-866-987-HIFU (4438).
--------------------------------------------------------------------------------
Canada also has trials, which have less strick guidelines:
To qualify you must have a PSA of 10. or less,
Gleason of 7 or less,
40 to 80 y.o.,
T1c & T2a,
and prostate total volume less than 40cc with an AP height less than or equal to 4.2cm. (If volume is greater than 40cc or height greater than 4.2 cm, one 3 monthly shot of an LHRH analogue may be provided, followed by re-imaging of the prostate to document total volume below 40cc.)
Contact: George Vrabec, MD gvrabec@hotmail.com
Abbotsford Regional Hospital Cancer Center
Abbotsford, British Columbia, Canada


Age 61 at DX
Biopsy 7/2008 Positive 1 of 12 cores positive 3+4 5% To 10%
Open Radical Prostatectomy 15/10/2008
Stage pt2c
Post op staging Gleason's Score 3+4=7
apical margin is focally positive
no extraprostatic extension
Seminal vesicles and lymph nodes clear
Catheter out on the 13/11/2008
4 week PSA < 0.1
26/1/2009  < 0.1
20/4/2009 < 0.1
11/6/2009 ultra sensitive psa 0.07
20/7/2009 < 0.1
26/8/09 Starting photon 3D CRT
13/10/09 Radiation Finished
25/11/09 ultra sensitive psa < 0.05
26/4/10   ultra sensitive psa < 0.05






Post Edited (6071) : 6/2/2010 3:56:21 PM (GMT-6)


James C.
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Date Joined Aug 2007
Total Posts : 4463
   Posted 6/2/2010 4:33 PM (GMT -6)   
6071, Can you tell me more about where you found this, maybe give me the link? As you know, HIFU is a controversial isue here, and I ned to determine if this is a legitimate FDA approved study or a private trial by the maunfacturer itself. The last line of the first section tends to make me think it may be a private trial, if so, then it probably will fall into the spam category and not allowed. I have also notified the owner of the Forum, explained what the issues are and he will be looking into it also. I am just trying to be proactive as you probably know who knee jerk reactions are here when HIFU is brought up. Thanks for posting this and we will see where it goes.

Notice to other members, let's not weigh in on this for now, let us see what the source and intent is first. No need to get a big stink stirred over what is probably a legit study.
James C. Age 63
Gonna Make Myself A Better Man www.youtube.com/watch?v=a6cX61oNsRQ&feature=channel
4/07: PSA 7.6, Recheck after 4 weeks Cipro-6.7
7/07 Biopsy: 3 of 16 PCa, 5% invloved, left lobe, GS3+3=6
9/07: Nerve Sparing open RRP, 110gms, Path Report- Stg. pT2c, 110 gms., margins clear
3 Years: PSA's .04 each test since surgery, ED continues: Bimix- .3ml PRN, Trimix- .15ml PRN


6071
Regular Member


Date Joined Jul 2008
Total Posts : 113
   Posted 6/2/2010 4:36 PM (GMT -6)   


Age 61 at DX
Biopsy 7/2008 Positive 1 of 12 cores positive 3+4 5% To 10%
Open Radical Prostatectomy 15/10/2008
Stage pt2c
Post op staging Gleason's Score 3+4=7
apical margin is focally positive
no extraprostatic extension
Seminal vesicles and lymph nodes clear
Catheter out on the 13/11/2008
4 week PSA < 0.1
26/1/2009  < 0.1
20/4/2009 < 0.1
11/6/2009 ultra sensitive psa 0.07
20/7/2009 < 0.1
26/8/09 Starting photon 3D CRT
13/10/09 Radiation Finished
25/11/09 ultra sensitive psa < 0.05
26/4/10   ultra sensitive psa < 0.05






Post Edited (6071) : 6/2/2010 3:42:38 PM (GMT-6)


James C.
Veteran Member


Date Joined Aug 2007
Total Posts : 4463
   Posted 6/2/2010 4:49 PM (GMT -6)   
I think I found the probable source of this, along with the US National Institute of Health study listing. Not sure which one it is, but it appears it is an approved study, which has been expected to start this year. Here's the listing of the current official approved NIH studies, all being carried out by the same Sonoblate manufacturer.

www.clinicaltrials.gov/ct2/results?term=ushifu

So, it appears a legit announcement of an approved study.
James C. Age 63
Gonna Make Myself A Better Man www.youtube.com/watch?v=a6cX61oNsRQ&feature=channel
4/07: PSA 7.6, Recheck after 4 weeks Cipro-6.7
7/07 Biopsy: 3 of 16 PCa, 5% invloved, left lobe, GS3+3=6
9/07: Nerve Sparing open RRP, 110gms, Path Report- Stg. pT2c, 110 gms., margins clear
3 Years: PSA's .04 each test since surgery, ED continues: Bimix- .3ml PRN, Trimix- .15ml PRN


Cedar Chopper
Regular Member


Date Joined Mar 2007
Total Posts : 432
   Posted 6/3/2010 6:44 AM (GMT -6)   

Friends,

Almost four years ago, Dr. Matten at M.D. Anderson mentioned HIFU to me as a future likely alternative to radiation or cryogenic treatment of prostrate cancer -
    - pending legitimate research.

James, thanks for verifying the "credentials" of this study.
Data interpretation of such studies is best left to a patient and his (no-financial-interest-in-choice-of-treatment) physician(s).

Thanks Again.

CCedar
ICTHUS


2 Years of PSA between 4 and 5.5  + Biopsy 23DEC06 
Only 5 percent cancer in one of 8 samples.  +  Gleeson 3+3=6
OPEN R P 16FEB07 at age 54. 1+" tumor - touching inside edge of gland.  + Confined:)
Pad Free @ 14 weeks.  PSA: 6 mths <.003  :)   9mths & 1 Yr.<.008
:)
18mths & 2 Yr & 3 Yr <.008 :)  
  5 Year Colonoscopy 19FEB08:  Clear!

el perro
Regular Member


Date Joined Mar 2010
Total Posts : 46
   Posted 6/3/2010 1:14 PM (GMT -6)   
From James C's link, it seems to me that the actual HIFU treatment arms of the trial are closed (have reached full enrollment) in the US, and are not yet recruiting in Canada. Only the brachytherapy "comparator" arms are still enrolling in the US. So basically no HIFU as primary treatment in US, on a trial or otherwise at this point. If I'm missing something please let me know as I'm still considering HIFU for my own situation. Thanks.
Dx 11/2008, Gleason 3+3
Active surveillance for now


Worried Guy
Veteran Member


Date Joined Jul 2009
Total Posts : 3743
   Posted 6/4/2010 7:59 PM (GMT -6)   
If HIFU works by raising the temperature of the tissue to 80-90 C in 2 -3 seconds. Assuming a volume of 2 cc that means the power of the pulse is 50 W. That is a lot of acoustic energy. Why not heat the tissue with 2.4GHz microwaves? It could be controlled to the exact same power level and the waves could be easily focused. Also the waves are easy to generate cheaply with a Gunn diode.
Has anyone heard of this method?
Any reason that it would not work?
Jeff

offpsa
New Member


Date Joined Jun 2009
Total Posts : 15
   Posted 6/5/2010 11:29 AM (GMT -6)   
yes, microwaves is a great idea, except they just keep on going, they must have something implanted for them to stop, and so they are experimenting with nano gold particles to stop the microwave, it's working, but will cost much, working with gold.  It's in trials at MD Andersen.
 

Worried Guy
Veteran Member


Date Joined Jul 2009
Total Posts : 3743
   Posted 6/5/2010 12:47 PM (GMT -6)   
Offpsa,
Thanks for the feedback. This got me thinking. I could come up with a frequency that would only penetrate to a desired depth. We have the technology. I can go up to 80 GHz if desired. That energy drops of very quickly.
If we want a concentration in an area below the surface.we can make a standing wave with one node on the surface and one of the opposite side of the tissue. I can make a pen sized 10-12 element Yagi that has the reflector at the back end. This would project the energy out the tip. I'll have to run the numbers and check out the side lobe losses. If they are too great then the surgeon cannot hand hold the device but that's where DaVinci shines.
Hmm...I'll have to experiment with a piece of steak and a thermal imager.
(I can do anything at my place.)
Jeff
Married 34 years, DX Age 56. First routine PSA test on April 8, 09: 17.8. Start 2 weeks of Cipro to rule out protatitis. May '09 PSA: 22.6, 3 weeks later: PSA: 23.2.
Biopsy 6/10/09: 7/12 scores positive, 20%-70%, Gleason 3+4=7, 3+3=6. Bone and C/T scans neg.
RP DaVinci -7/21/2009 @ Univ of Roch Medical Center
Left nerve gone, right partial spared.
Catheter removed - 7/31/2009 Pathology report received:
Gleason 3+4=7, Tumor size: 2.5 x 1.8 cm, location: both lobes and apex.
Extraprostatic extension present; Perineural invasion: present, extensive.
No Malignancy in Seminal Vesicle, vasa deferentia, lymph nodes 0/13
Prostate mass 56 grams. Pathologic Stage: pT3aN0MX
Post Surgery Status:
Potency - 12/11 5 months, Still no activity, zip. Using pump daily since 11/11. No effect with 20 mg of Cialis or 100 mg of Viagra. Shots next See Uro 1/22/10 Trimix #1. Try 0.08- 25%, 0.12-25%, 2/26/10 try 0.16 First Success! 90%.
Incontinence - 8/20 4 full pads per day
.. 9/7 3-4 full pads per day. Try controlling fluids.
12/11/09 5 months: 3 pads per day, 400-450ml/day
02/26/10 7 months: 3 pads but leak is now 320 ml (5 day avg.)
03/22/10 8 months: 3 pads per day, 280 ml/day (5 day avg.) PT says all muscles are tight and working properly. There must be another issue. Uro mtg 4/23.
5/22/10 10 months: 2 pads per day, 190 ml/day Scope on June 12.
Post Surgery PSA - 9/3 6 weeks - 0.05; 10/13 3 months - 0.04, 1/14 6 months - 0.05, 4/14 9 months - 0.04 and <0.01 with ECLIA.


el perro
Regular Member


Date Joined Mar 2010
Total Posts : 46
   Posted 6/5/2010 2:14 PM (GMT -6)   
Jeff,
Mayo Clinic has a page on RF Ablation for Cancer using a needle-probe type device. Only appears to be used for liver, lung, kidney and bone cancers.
www.mayoclinic.org/radiofrequency-ablation/

I also found a system by Medtronic used to ablate prostate tissue for BPH.
professional.medtronic.com/products/prostiva-rf-ablation-system-for-symptomatic-bph/index.htm

Now I'm curious why these type devices couldn't be used in prostate cancer? Seems like it would produce a similar effect as HIFU. I guess the RF probe would still have to penetrate into the prostate itself though, unlike HIFU?
Dx 11/2008, Gleason 3+3
Active surveillance for now


Worried Guy
Veteran Member


Date Joined Jul 2009
Total Posts : 3743
   Posted 6/5/2010 6:13 PM (GMT -6)   
El Perro,
I'm thinking that the microwave energy can be beamed into the prostate. I could set the depth beforehand by selecting the frequency according to the absorption rate of the tissue. You would not have to penetrate the capsule.
I think that's why they seed with the gold particles. The microwaves heat the gold.
Now that I know the wattage, there are all sorts of possibilities.
How about short wave UV-C? I've used that for killing all sorts of DNA based life forms.
It's time to get creative.
I regret that I let the surgeon put my removed prostate in a bio-hazard container. I should have asked to take it home for experiments.
Jeff
Think I could run clinical trails in my basement? Any volunteers? I don't have any anesthetic but my rates are very low.

el perro
Regular Member


Date Joined Mar 2010
Total Posts : 46
   Posted 6/5/2010 10:14 PM (GMT -6)   
I'm all for non-invasive, so sounds good. I'll sign up when you get to Phase III trial!
Dx 11/2008, Gleason 3+3
Active surveillance for now


Worried Guy
Veteran Member


Date Joined Jul 2009
Total Posts : 3743
   Posted 6/6/2010 5:28 AM (GMT -6)   
El Perro,
I also can do colonoscopies - even broadcast it live on TV channel 19 so the whole neighborhood can watch. And they say they can't record DaVinci procedures . Ridiculous.

I'm thinking now about imaging with ultrasound, calculating the distance and size of the volume you want to hit. Then using a fourier transform to calculate and create a wave that does the job but diverges when past the target. I only need 100 Watt -sec. to heat 2 cc. Maybe it should be pulsed at about 1 HZ and the surgeon instructed to move wand after each pulse. Hit with 50 pulses.

Interesting physics problem... It is very close to the bladder neck and urethra so that must not be damaged. Hmmm...

You'll be the first to get the Phase III invitation.
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