Clinical Trial?

Did you by any chance get a retest on that psa? new blood draw maybe different lab, yo know for grins and giggles.

During the first meeting with the RO, he did a DRE. He could feel a lump - indeed I could feel him feeling the lump. He said it might be cancer but said it could also be just scar tissue. Test on Monday could reveal more.

3 consecutive rises? My doc told me from day 1 that anything over .2 meant it was radiation time.

When my PSA went above <.1 I plotted several curves based on different linear and logarithmic rates of continuous growth, based on the 3 data point I had at the time. Additional tests ruled out several of the projections, but other possible outcomes remained.

My projections assume the .1 reading could range from .10 to .19 It also assumes constant linear or logarithmic rates of growth. I don't know if pauses or remissions occur with no intervention.

The logarithmic curve that fits my current numbers shows that I crossed the .2 line 3 months ago and should be around .25 now and would be nearly .4 in 6 months.

The linear projection that fits my current numbers shows that it would exceed .3 in 6 months.

The best linear projection puts off exceeding the.2 threshold by another 6-7 years, but that assumes the most recent PSA was .12 rather than .2

I am content with the numbers. All my projections suggest that sometime in the future I will have to deal with this. I would rather get it over with while I am relatively young and healthy. I have abandoned hope in ED recovery and am easily tolerating some minor incontinence.

Again, my original question: any thoughts about participation in the clinical study?

White Bird said...
...

Again, my original question: any thoughts about participation in the clinical study?

I guess I am not as altruistic. If it were me, I would try to figure out which of the 3 was best for me and choose that from the get go.

In my case I felt the appeal of SBRT being completed in only 5 fractions over a week and a half much more appealing than 7-9 weeks of IMRT.

I also opted to do it concurrently with Provenge the leverage the abscopal effect.

In fairness I would have never come up with this on my own and had the benefit of Tall Allen's mentoring.

prostate-cancer.org/abscopal-effect/

Where does the White Bird call home? Logistics could also affect your options.

LupronJim

Quote from Beejane: "....Studies show people do better in either arm of a clinical study. You are monitored more closely. You have easy access to medical attention if there are any problems. You receive more frequent PSA blood tests and have blood pressure, pulse and weight tested every three months (or whatever interval your study includes). Doctors like to look after their patients enrolled in their studies. They are well paid for them so want to keep you alive."

Now that is the sort of new information I have been looking for. Thanks Bee.

White Bird,

You're quite right that PSA of .2 is standard definition for biochemical recurrence after prostatectomy. That is based on the fact that for a long time, .2 was the lowest PSA that could be reliably measured; and most of the randomized clinical trials that demonstrated an advantage to earlier treatment began before accurate lower measurements were possible or routine. In an interesting analysis, my RO found that, among high risk men, any PSA value ≥.03 reliably predicted that the PSA would rise to ≥.2.

Ultra-sensitive PSA Following Prostatectomy Reliably Identifies Patients Requiring Post-Op Radiotherapy

But to address your concern, you said, "I see that there is some small risk of cardiovascular and diabetic problems with the hormone treatments. I am borderline for both and am wondering if I should forgo the HT until it becomes a necessity."

The clinical trial you describe (is this RTOG 0924?) mentions only 2 months of HT pre-treatment before radiation. Usually, there is concurrent treatment as well, which would bring the total to 4 months, or often, they do 2 months after, which would bring the total to 6 months. If it's RTOG 0924, the doctor may give the patient up to 32 months of ADT at his discretion (not randomized). I've never seen anything that showed that 4-6 months of ADT was associated with cardiovascular or diabetic problems. Even with 1.5-3 yrs, I don't think it's a big concern, although close monitoring is important. It is only with much longer term HT that those become a concern.

However, even if there's little reason to be concerned about those side effects, there are a couple of other considerations that only you can answer:

(1) Are you indifferent to whether you are assigned to the 3 alternatives? ADT has proven to be beneficial for high risk PC in a recent clinical trial (DART 01/05). GS8 also carries greater risk of lymph node involvement, although it is not at all clear which protocol is optimal.

(2) Should you be opting for longer term HT? High risk cancers, and your GS 8 puts you in that category, generally respond to HT for at least 18 months. Your lack of positive margins increases the likelihood that such long-term clean-up may be required. If this is RTOG 0924, your doctor may be able to prescribe longer term ADT at his discretion.

If this is RTOG 0924, it is a very important study that may lead to great improvements in the way men with recurrences will be treated in the future. You will be closely monitored, and all radiological design is very precisely controlled as well. Your participation would make a valuable contribution to the rest of us.

- Allen

D'Oh! RTOG 0924 and DART 01/05 are only applicable to men seeking original radiation therapy, not for men looking at salvage radiation (SRT) for a recurrence, like yourself, so please ignore what I said about them in my post above. I apologize for that.

The evidence for the benefit of ADT and/or whole pelvic radiation with SRT comes from altogether different studies. For example, the following single-institution, smaller randomized controlled trial from Korea this year found that for high risk patients undergoing SRT, whole pelvic radiation and ADT had better outcomes. The benefit of salvage whole pelvic radiation on top of the ADT did not reach statistical significance in the small sample of men, whereas late term rectal side effects increased.

Whole pelvic irradiation for prostate cancer patients with a biochemical relapse following radical prostatectomy

There have been dozens of studies of ADT+SRT, but only one that I know of was a randomized controlled trial. In general, the addition of ADT seems to improve outcomes in most of those studies. One recent trial may be particularly relevant to you. The single randomized controlled trial, RTOG 9601, looked at SRT with 2 years of bicalutamide as the only kind of hormone therapy. They found that after 7 years of follow up, freedom from PSA progression was 57% for SRT plus bicalutamide vs 40% for SRT alone. The difference was more marked among the men with GS8-10 - 56% vs 26%. Urinary and Rectal side effects were not significantly different.

Initial Report of RTOG 9601: A Phase III Trial in Prostate Cancer: Anti-androgen Therapy (AAT) with Bicalutamide during and after Radiation Therapy (RT) Improves Freedom from Progression and Reduces the Incidence of Metastatic Disease in Patients following Radical Prostatectomy (RP) with pT2-3, N0 Disease, and Elevated PSA Levels

- Allen

It never ceases to amaze me how words collated in in a certain fashion can lead well meaning and not so well meaning folks to communicate meanings that serve their own purposes. Imagine an RO grabbing on to a small trial or study that basically says every hi risk patient,conveniently{ deep within the double talk they "define" hi risk as epe and positive margins, thereby excluding many hi risk men.} will need SRT Then they , in the conclusion, omit that fact. i.e, epe and positive margins. Be advised all 247 had epe and/or positive margins. Most folks peruse these abstracts,but study the conclusion. A study, that started in 1991. When was the ultra sensitive first introduced that tested to .03 ? How did the bell curve of the men involved look in the interval of time of the study/trial, whatever. Lets see 247 men over 22years. So that was a pretty small group of men over a long period of time. Were the man cherry picked over a 22 year time frame...they were " identified" not randomized.For all we know the psa of everyone was already.199 or higher. I mean back in 1991 just about everyone tested was over.03 I could go on and on, many holes. Suffice it to say Pca can deliver a capitol punishment, I'm not sure this " evidence" would convict in a small claims court. I need more clarity. Fancy letterheads and big words confuse me.. " Im just a caveman lawyer" Phil Hartman. Photoshopping is not just the purview of the media and it is spreading and migrating at on increasing rate. Its all in the abstract, caveat emptor. Which is an apt title... Abstract….think Art. This may just be the deterioration of an aging mind that is busy cutting paper dolls, twirling his hair. but I've done pretty well staying sane in an insane world thus far. But ya know, who really knows... whats ,what anymore. Guess I'll stick with that little seed within, which ever faithfully buds… I mean ' where else would I go ….?? ' Thanks for the ear. I paints what I see's and I'm smelling something metallic.

Congrats ion getting into the arm you wanted.

LupronJim