Questions on Clinical Trials???

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melange123
New Member


Date Joined Jan 2010
Total Posts : 13
   Posted 1/15/2010 7:05 PM (GMT -6)   
Hi there I am new to this forum...
 
My husband had a protatectomy in July 08 and his PSA started to rise so he is currently in clinical trials at City of Hope. It is a mushroom trial, I believe it's a white button made into pill form. He's been on it since September 09 and his PSA is continuing to rise. I'm concerned that they are having him continue in the trials and not suggesting any other treatment??? Has anyone out there done clinical trials? Not sure when you say enough is enough and try something else?? I'm not sure if it's because of his high Gleason score and positive margin that they aren't suggesting radiation?? Any info would be great!!
 
Thanks, Melissa
Wife of:
Age 59
DX 05/07/08 , PSA 7.4, Biopsy Positive 
Gleason Score 4+4 = 8 
Bone scan and MRI negative
Da Vince surgery 06/20/08  City of Hope
Post Gleason report  4+4 = 8
Lymph nodes on both sides negative
1 positive Margin
07/29/08 first PSA 0.0
07/08 - 06/09 PSA 0.0 - 0.1
07/09 PSA 0.2
08/09 PSA 0.3
09/09 - 010/09 PSA 0.4
10/09 Start Clinical Trials COH (Mushroom)
11/09 PSA 0.5
12/09 PSA 0.5


60Michael
Veteran Member


Date Joined Jan 2009
Total Posts : 2243
   Posted 1/15/2010 8:14 PM (GMT -6)   
Melissa,
You have asked a good question and I am not sure if any of us have the experience to answer it correctly. Your husbands stats are somewhat like mine even the rise in PSA. The radiation oncologist offered a clinical trial to me but with HT and more ectensive radiation as my options as well as the normal radiation to the prostate bed. After my bone scan came back clear I just said lets go with the radiation and declined the clinical trial. The info for that study said that I could drop out at an time. I would sggest getting second opinions and with a Urologist and other experts including a radiation oncologist. I hope all goes well for both of you and hope that you all can become clear on how to move forward as soon as possible.
Be Blessed
Michael
Dx with PCA 12/08 2 out of 12 cores positive 4.5 psa
59 yo when diagnosed
Robotic surgery 5/09 Atlanta, Ga
Catheter out after 10 days
Gleason upgraded to 3+5, volume less than 10%
Margin slightly involved
2 pads per day, 1 depends but getting better,
8/5 1 depend at night only, now none
 started ED tx 7/17, slow go
Post op dx of neuropathy
3 months psa.01, 6 month psa.4, 6 1/2 month psa.5
Consulting with Primary Urologist for further tx.
Great family and friends
Michael


goodlife
Veteran Member


Date Joined May 2009
Total Posts : 2692
   Posted 1/15/2010 11:12 PM (GMT -6)   
Are you sure he is getting the medication and not a placebo ? Many trials have a control group that gets a placebo.

Goodlife
Age 58, PSA 4.47 Biopsy - 2/12 cores , Gleason 4 + 5 = 9
Da Vinci, Cleveland Clinic  4/14/09   Nerves spared, but carved up a little.
0/23 lymph nodes involved  pT3a NO MX
Catheter and 2 stints in ureters for 2 weeks .
Neg Margins, bladder neck negative
Living the Good Life, cancer free  6 week PSA  <.03
3 month PSA <.01 (different lab)
5 month PSA <.03 (undetectable)
6 Month PSA <.01
1 pad a day, no progress on ED.  Trimix injection
No pads, 1/1/10


don826
Veteran Member


Date Joined May 2008
Total Posts : 1010
   Posted 1/16/2010 8:39 AM (GMT -6)   
Dear Melissa,

I was offerred an opportunity to participate in a trial at my diagnosis. Turned it down flat. First line should be to try conventional therapies before going experimental. (Just my opinion) Your husband should look at salvage radiation and/or hromone therapy before entering a trial. If either of those fails perhaps then on to the treatments of last resort. Advice given by Michael is good. See another urologist or an oncologist.

Best to you and your husband.
Don
Diagnosed 04/10/08 Age 58 at the time
Gleason 4 + 3
DRE palpable tumor on left side
100% of 12 cores positive for PCa range 35% to 85%
Bone scan clear and chest x ray clear
CT scan shows potential lymph node involvement in pelvic region
Started Casodex on May 2 and stopped on June 1, 2008
Lupron injection on May 15 and every four months for next two years
Started IMRT/IGRT on July 10, 2008. 45 treatments scheduled
First 25 to be full pelvic for a total dose of 45 Gray to lymph nodes.
Last 20 to prostate only. Total dose to prostate 81 Gray.
Completed IMRT/IGRT 09/11/08.
PSA 02/08 21.5 at diagnosis
PSA 07/08 .82 after 8 wks of hormones
PSA 10/08 .642 one month after completion of IMRT, 6 months hormone
PSA 03/09 .38 six months post radiation and nine months into hormones 
PSA 06/09 .36 or .30 depending on who did the test
PSA 09/09 .33 one year after IMRT and 16 months into hormone
 
 
 


60Michael
Veteran Member


Date Joined Jan 2009
Total Posts : 2243
   Posted 1/16/2010 11:21 AM (GMT -6)   
Melissa,
I would also discuss with his current tx team, what are the expecatations and are they on target. Would do that first and then get a second opinion if you all are not satisfied. best to you and your husband. Oh, and welcome to HW.
Michael
Dx with PCA 12/08 2 out of 12 cores positive 4.5 psa
59 yo when diagnosed
Robotic surgery 5/09 Atlanta, Ga
Catheter out after 10 days
Gleason upgraded to 3+5, volume less than 10%
Margin slightly involved
2 pads per day, 1 depends but getting better,
8/5 1 depend at night only, now none
 started ED tx 7/17, slow go
Post op dx of neuropathy
3 months psa.01, 6 month psa.4, 6 1/2 month psa.5
Consulting with Primary Urologist for further tx.
Great family and friends
Michael


melange123
New Member


Date Joined Jan 2010
Total Posts : 13
   Posted 1/16/2010 11:43 AM (GMT -6)   
Thanks for all your information. My husband is in a clinical trial that is in phase 2 and everyone receives the medication there are no placebos. The ultimite goal of the trial is to bring down the PSA. They had originally said if the PSA doubled that he would be let go from the trial but have since changed that.  I am curious as to the different types of radiation… Since his Gleason score was so high and the return of rising PSA does that indicate a high probability that it’s not just in the prostate bed? He is going to see a holistic Dr on Tuesday just to see what’s offered. It’s difficult being a partner to this disease and wanting what’s best for him, yet letting him make the decisions since it is his body…  I’ve been lurking on this board for quite a while and finally was able to post. Thank you all for sharing so honestly it has truly been a comfort coming here...
 
Melissa
Wife of:
Age 59
DX 05/07/08 , PSA 7.4, Biopsy Positive 
Gleason Score 4+4 = 8 
Bone scan and MRI negative
Da Vince surgery 06/20/08  City of Hope
Post Gleason report  4+4 = 8
Lymph nodes on both sides negative
1 positive Margin
07/29/08 first PSA 0.0
07/08 - 06/09 PSA 0.0 - 0.1
07/09 PSA 0.2
08/09 PSA 0.3
09/09 - 010/09 PSA 0.4
10/09 Start Clinical Trials COH (Mushroom)
11/09 PSA 0.5
12/09 PSA 0.5


don826
Veteran Member


Date Joined May 2008
Total Posts : 1010
   Posted 1/16/2010 12:26 PM (GMT -6)   
Hi Melissa,

There are two types of radiation. Photon and proton. Photon is more widely avaliable and somewhat less costly. Photon is generally stated as IMRT/IGRT. In your husband's case he had one positive margin, negative nodes and clear scans so it could be that his remaining PCa is in the prostate bed. In the case of a still localized disease IMRT is very effective. The course is 35 to 45 treatments and each one takes about 15 minutes. I would certainly look into this. Still a good chance to knock this out.

I am uncertain as to the application of proton radiation for salvage. Perhaps someone else can shed some light.

Best to you and hubby,
Don
Diagnosed 04/10/08 Age 58 at the time
Gleason 4 + 3
DRE palpable tumor on left side
100% of 12 cores positive for PCa range 35% to 85%
Bone scan clear and chest x ray clear
CT scan shows potential lymph node involvement in pelvic region
Started Casodex on May 2 and stopped on June 1, 2008
Lupron injection on May 15 and every four months for next two years
Started IMRT/IGRT on July 10, 2008. 45 treatments scheduled
First 25 to be full pelvic for a total dose of 45 Gray to lymph nodes.
Last 20 to prostate only. Total dose to prostate 81 Gray.
Completed IMRT/IGRT 09/11/08.
PSA 02/08 21.5 at diagnosis
PSA 07/08 .82 after 8 wks of hormones
PSA 10/08 .642 one month after completion of IMRT, 6 months hormone
PSA 03/09 .38 six months post radiation and nine months into hormones 
PSA 06/09 .36 or .30 depending on who did the test
PSA 09/09 .33 one year after IMRT and 16 months into hormone
 
 
 


goodlife
Veteran Member


Date Joined May 2009
Total Posts : 2692
   Posted 1/16/2010 12:31 PM (GMT -6)   
Melissa,

Comparatively speaking, his PSA is still low. There is a 20 to 30 % chance that salvage radiation may be successful, certainly higher odds than other treatments.

You will find men who have had higher PSA's who have done salvage radiation and been successful.

Goodlife
Age 58, PSA 4.47 Biopsy - 2/12 cores , Gleason 4 + 5 = 9
Da Vinci, Cleveland Clinic  4/14/09   Nerves spared, but carved up a little.
0/23 lymph nodes involved  pT3a NO MX
Catheter and 2 stints in ureters for 2 weeks .
Neg Margins, bladder neck negative
Living the Good Life, cancer free  6 week PSA  <.03
3 month PSA <.01 (different lab)
5 month PSA <.03 (undetectable)
6 Month PSA <.01
1 pad a day, no progress on ED.  Trimix injection
No pads, 1/1/10


60Michael
Veteran Member


Date Joined Jan 2009
Total Posts : 2243
   Posted 1/16/2010 2:11 PM (GMT -6)   
Holistic tx does have a place in tx and I have heard of the herbal preparation PC-SPES being used for both localized and advanced PCa. My own thought on that is I would only use it in conjuction with another type tx, one that gave me the best chance for a cure and longer life. Your husband sounds like he has an open mind so I hope he makes a wise choice. Offer support as you obviously are, but also be willing to speak your mind in a forthright manner. Good luck to the 2 of you.
Michael
Dx with PCA 12/08 2 out of 12 cores positive 4.5 psa
59 yo when diagnosed
Robotic surgery 5/09 Atlanta, Ga
Catheter out after 10 days
Gleason upgraded to 3+5, volume less than 10%
Margin slightly involved
2 pads per day, 1 depends but getting better,
8/5 1 depend at night only, now none
 started ED tx 7/17, slow go
Post op dx of neuropathy
3 months psa.01, 6 month psa.4, 6 1/2 month psa.5
Consulting with Primary Urologist for further tx.
Great family and friends
Michael


Jerry1
Regular Member


Date Joined Mar 2007
Total Posts : 460
   Posted 1/16/2010 4:37 PM (GMT -6)   
 
Melang123
 
I also agree with the others that at this point he still has the possibility to be cured with Salvage Radiation with a positive margin there is a very good chance that the cancer is local.  My gleason score is also 4+4 and current PSA 0.5 and I am starting radiation on Monday my odds of a cure are a little less because I had no positive margins but it is the only chance for a cure and I am going for it. 
 
Jerry1
Age 70
DX 8/13/08 , PSA 4.0, Biopsy 14 samples 1 positive 12% of sample,
Gleason Score 4+4 =8  Bone scan and MRI negative
Da Vince surgery on Oct 17, 08 Florida Hospital Dr Vipul Patel
Post Gleason report  4+4 = 8 Lymph nodes on both sides negative
margins Negative  Stage II (pt2a) 
Cath out on October 29th left in longer due to small leak.
11/19/08 dry no more pads
12/2/08 first PSA <0.1
 3/6/09 6 Month PSA 0.0
6/3/09 9 month  PSA 0.1
7/14/09  PSA still 0.1
10/15/09 PSA 0.3
10/26/09 surgery to remove 3 clips in bladder neck  
11/16/09 PSA 0.3
12/14/09 PSA 0.4 
12/28/09 PSA 0.5
Start radiation treatments ib January 18th. 


James C.
Veteran Member


Date Joined Aug 2007
Total Posts : 4463
   Posted 1/16/2010 7:19 PM (GMT -6)   
melenge123 y, you said:

They had originally said if the PSA doubled that he would be let go from the trial but have since changed that.

I don't understand this statement. Do you mean the change doesn't now allow him to drop out? How can they not let him go, if he wishes. He does have a choice to drop out? Or they gonna fine him or something?
James C. Age 62
Co-Moderator- Prostate Cancer Forum
4/07 PSA 7.6, referred to Urologist, recheck 6.7
7/07 Biopsy: 3 of 16 PCa, 5% involved, left lobe, GS 3/3=6
9/07 Nerve sparing open RRP 110gms.- Path Report: GS 3+3=6 Stg. pT2c, 110gms, margins clear
24 mts: PSA's: .04 each test since surgery, ED Continues-Bimix .3ml PRN or Trimix .15ml PRN


melange123
New Member


Date Joined Jan 2010
Total Posts : 13
   Posted 1/16/2010 10:53 PM (GMT -6)   
I guess I didn't state that clearly. Yes, he can leave the trial at anytime he wishes, it just confussed me that they said "he would be drop from the trial if the PSA doubled and then said he could stay if it doubled" We talked today about it and I suggested we meet with the Oncologist Radiologist at COH to see what he has to say as far as treatment. He has an appointment with the Clinical trial Dr on Monday so he will see about getting into radiology for an appt....
 
Thanks again for all the information
Wife of:
Age 59
DX 05/07/08 , PSA 7.4, Biopsy Positive 
Gleason Score 4+4 = 8 
Bone scan and MRI negative
Da Vince surgery 06/20/08  City of Hope
Post Gleason report  4+4 = 8
Lymph nodes on both sides negative
1 positive Margin
07/29/08 first PSA 0.0
07/08 - 06/09 PSA 0.0 - 0.1
07/09 PSA 0.2
08/09 PSA 0.3
09/09 - 010/09 PSA 0.4
10/09 Start Clinical Trials COH (Mushroom)
11/09 PSA 0.5
12/09 PSA 0.5


60Michael
Veteran Member


Date Joined Jan 2009
Total Posts : 2243
   Posted 1/17/2010 9:07 AM (GMT -6)   
We will keep you all in our thoughts and maybe something quite positive will happen as you have these discussions with the tx team and oncologist. Keep us posted if possible.
Michael
Dx with PCA 12/08 2 out of 12 cores positive 4.5 psa
59 yo when diagnosed
Robotic surgery 5/09 Atlanta, Ga
Catheter out after 10 days
Gleason upgraded to 3+5, volume less than 10%
Margin slightly involved
2 pads per day, 1 depends but getting better,
8/5 1 depend at night only, now none
 started ED tx 7/17, slow go
Post op dx of neuropathy
3 months psa.01, 6 month psa.4, 6 1/2 month psa.5
Consulting with Primary Urologist for further tx.
Great family and friends
Michael

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