177Lu-j591 Radio-immunotherapy Article - looks promising

www.pcf.org/site/c.leJRIROrEpH/b.8922409/k.8A41/Moving_the_Dial_to_Cure_Can_Targeted_Radiotherapy_actually_eradicate_tumors_in_men_with_advanced_prostate_cancer.htm

Article from Prostate Cancer Foundation on trial of radio-immunotherapy
agent 177Lu-J591

Thanks Robert. Did I miss when phase 3 will begin?

Further information:

Clinical Trial Link: http://clinicaltrials.gov/ct2/show/NCT00859781?term=NCT00859781&rank=1

Contact Information: For further information on this clinical trial, please call: 646-962-2072

Elgibility:

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy.
• Biochemical progression (rising PSA) after medical or surgical castration

• High risk of systemic progression defined as:

  1. Rising PSA as defined above and either:
  2. Absolute PSA > 20 ng/mL AND/OR
  3. PSA doubling time < 8 months
• No evidence of local recurrence or distant metastases
• Age >18 years.
• Serum testosterone < 50 ng/ml
• Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
• Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Use of red blood cell or platelet transfusions within 4 weeks of treatment
• Use of hematopoietic growth factors within 4 weeks of treatment
• Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
• Prior radiation therapy encompassing >25% of skeleton
• Prior treatment with 89-Strontium or 153-Samarium containing compounds (e.g. Metastron®, Quadramet®)
• Platelet count <150,000/mm3
• Absolute neutrophil count (ANC) <2,000/mm3
• Hematocrit <30 percent or Hemoglobin < 10 g/dL
• Abnormal coagulation profile (PT or INR, PTT) > 1.3x ULN
• Serum creatinine >2.5 mg/dL
• AST (SGOT) >2x ULN
• Bilirubin (total) >1.5x ULN
• Serum calcium >11 mg/dL
• Active serious infection
• Active angina pectoris or NY Heart Association Class III-IV
• Karnofsky Performance Status <70
• Life expectancy <12 months
• History of deep vein thrombosis and/or pulmonary embolus within 3 months of study entry
• Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
• Prior investigational therapy (medications or devices) within 6 weeks of treatment.
• Prior use of ketoconazole for the purposes of prostate cancer therapy
• Known history of HIV.
• Currently active other malignancy other than non-melanoma skin cancer.

This is 49 PACKARD
Been fighting prostate cancer for 8 full years.
Have done my share of test trials over the years.
This test trial is a combination of drug called j591+Ketoconazole is being offered at Georgetown University DC.
It is a Phase II trial. NCT00859781
I have a appointment there on February 19,2014 to talk about joining.
Anything that sounds too good to be true probably is.

Hi All:

Not so good of report from Georgetown University.
You cannot have any tumors, and it looks like I have three.
I have two on the pelvis and one on rib cage.
This was enough to keep me out of trial.
PSA is now at 146.
I will be going back to NIH and do the Xtandi trial.
I still feel great, except for the emotional part.
But that is nothing new to me.

49Packard

Hey Mr. wampuscat

Check this web site out.
As you answer the 5 or so questions the trial for you are present.(I LOVE It)

I am very early in my search right now. My Urologist does not know about my HOT stops.
If you get to NIH let me know it is only a 2 hour drive for me

www.gumdroptrials.org/

http://gumdroptrials.org/
49packard

The word "cure" got my attention but the results at the end of the report say average life extension is 22 months?? I'm confused by what seems such a short time when the word "cure" was used. Like everyone else here, I look forward to the day a cure knocks this disease in the dirt for good.

Hi All:

Sept is going to be here before you know it.
September is Prostate cancer month.
Just getting ready for our next Wheels for Prostate Cancer Research event.
Here’s a link to my video http://youtu.be/AdJGMAQssec

Mr.49 Packard

Hi All from 49 Packard:

New video of prostate support.
http://youtu.be/aGgXcMSEliQ

Still waiting for Xtandi to start working.
PSA went up to 184.5 from 147.0
Also started XGEVA for bone help.
Feel like a drugie

49packard said...
Hey Mr. wampuscat

Check this web site out.
As you answer the 5 or so questions the trial for you are present.(I LOVE It)

I am very early in my search right now. My Urologist does not know about my HOT stops.
If you get to NIH let me know it is only a 2 hour drive for me

www.gumdroptrials.org/

http://gumdroptrials.org/

49packard

Thanks for that link, Packard. Even though it still confuses my case of no surgery nor radiation nor chemo but mets at initial diagnosis and presents trials for castrate resistant mCRPC, will save me a lot of time just scanning through the much smaller answer set

gumdroptrials.org/#who=patient&what=prostate&ans=xynnyynnxxxxxxxxxxxxx&ver=4&so=2%2C1

LupronJim

Some guys have much larger prostates than I do. It was 50 (50.4 on one measure and 48.6 on the other pre-Lupron) which is oversized but not huge compared to guys is 80's or even triple digits. Thanks to the Lupron it has shrunken to 31.6 which approaches normal size that is on average about 11 grams, anywhere from 7-16 per Wiklopedia. Average on this site for guys who have not had their's removed is much higher.

I have no BPH symptoms.

Yes, in theory the mets are shrinking as is the prostate, but medical oncologist not thinking about surgery nor radiation while I am responding so well to Lupron and Xgeva.

He is of the school one remedy at a time as long as I can milk the Lupron while keeping the PCa guessing what we throw at it next, and other guys like Snuffy Myers or Scholz/Lam think we should be attacking aggessive G9 with the forces they deserve. I have an appointment with latter in June when I will be in Calif to at least listen to the other viewpoint.

Both opinions have merit. So I will decide after I meet with Dr. Jeffrey Turner from their practice but understand all 3 partake in parts of the interview/appt. Dr. Turner was also highly recommended by some folks at Sonny's GFMPH gathering who had seem him, and is a little less expensvie than Scholz who runs the practice and Lam who leads their R&D. Others there also had great things to say about Scholz and Lam.

Myers just interviewed Scholz in his weekly video

/askdrmyers.wordpress.com/

The part that caught my attention in the interview with Dr Scholz was:

"Invasion of the Prostate-Snatchers is focused on the newly diagnosed. My co-author came up with a catchy title, but a less creative title could have been Anything But Surgery. The book talks about all the alternatives to surgery: active surveillance; hormone treatments; radiation; seed implants; cryotherapy; and focal treatment. It makes a clear message that almost any other option has fewer side effects and better cure rates than surgery. But the popularity of surgery is not likely to change in the near future because right now mainly urologists are treating prostate cancer. I felt compelled to write the book because people generally do not get an opportunity to hear a medical oncologist’s viewpoint."


LupronJim

Hi Packard.

Glad your PSA is again on a downward slope.

LupronJim

Hey 49pack,

Hope we get to see each tomorrow(Tuesday) at NIH. I should be in phlebotomy around noon and then headed upstairs.

Jim