University of Utah Huntsman Institute TAK-700 Clinical trial

Foam,

These are good news. Clinical trials are safe, one is well looked after and all the monitoring (tests, etc) is free of charge. The only worry is if they group you into the cohort not getting the "special" drug. You should be assured that you will use that drug, not only the hormonal treatment.

Typicaly most of the participants in these type of trials need to be free from chemo. That could be the reason for your oncologist to change his initial protocol (HT+Chemo).

Please let us know details of the trial.

Your story is here: https://csn.cancer.org/node/302660

A link about Trials at Utah;

http://healthcare.utah.edu/clinicaltrials/participation.php

Best wishes,

VG 

receiving  

Did your oncologist decide that radiation would not be a good idea ?

There is a Portuguese quote that I would like to tell you in English but do not know how to translate. It simple means to "Be inquisitive, use wisdom and ask".

Not even your doctor expects you to know everything but if suspicious about his intent then ask till you get a satisfying answer. I do not think that he is rushing you to the trial. I guess that he just wants to start a therapy the soonest and without assurances of "someone to pay" then he is looking for possibilities. It is wise to be accompanied by a family member and take notes when visiting for consultations. Use diplomacy when inquiring.

You can ask details of the trial. Which drug is used, the purposes and the duration of the trial. Also about the monitoring after the trial; is it included? Are all tests free of charge?

I believe the situation made you anxious. You are dealing with the unknown and, still worse, without assurances of an insurance to pay the costs. This is pretty bad. You need help on the matter and the best way is to visit your local health authorities. I think that any hospital can give you information on how to proceed. Your doctor is one of the sources but you should get a second opinion from others. Getting involved in the trial may solve the payment of Lupron but it may not include future treatments.

In this pharmaceutical link they inform about the "Patient Assistance Programs for Lupron Depot-PED". They may have a similar program for chemo, etc. Call them and get informed on how to be involved;

http://www.drugs.com/price-guide/lupron-depot-ped

The upper body CT scan is important. It will check the lungs and the upper body's lymph nodes. What about a DEXA scan to verify bone loss? This is also important for patients recommended to chemotherapies. Ask your doctor to include the test.

Regarding Dr. Agarwal, he is famous at ASCO. He is a researcher to SWOG programs therefore someone to trust when dealing with an advanced case. I do not know if you have met him already but he also can help you understanding things on the trial. SWOG is a famous in running PCa trials since 2009. They have one that concerns the hormonal therapy in stage IV patients. I wonder if this is the trial you have been suggested?
This trial does not include any “newer” drug but simple tests in Stage IV patients the traditional ADT drugs (LHRH agonist and Antiandrogen) administered solo or combined against a placebo cohort, also done to verify continuous administration against intermittent.
Here are details; https://clinicaltrials.gov/ct2/show/NCT00002651

You can read their controversial findings in this interim report of 2011;
http://jco.ascopubs.org/content/early/2011/04/18/JCO.2010.32.2776.full.pdf

In any case, SWOG has done many trials using several medications including the famous chemo drugs Docetaxel and Estramustine, with confirmed results that may be the actual choice of your doctor to treat you. Ask him the name of the “special”. Dr. Agarwal knows about all the trials and their results. He can provide you peace of mind. Trust him but get the drug. Do not become a member of the placebo group.

Best wishes,

VGama

Foamhand,

Your doctor's notes are certainly well detailed. It answers the question I had regarding radiation very clearly.  Postponing chemo until essential is a good idea, as chemo applied to metastatic PCa is palliative, not curative.  Don't use it until necessary, as it is harsh (probably beginning with Taxotere, but that most likely is years away).

You seem to have a very good medical team. Hormonal Therapy often keeps the disease beaten back for many, many years.

max

Foamhand,

I think it better for you to continue our exchanged opinions about the trial in this thread (if you want). Nobody would understand your comment in the other newer thread without the contents of this one.

Here is a copy of your information on the trial:

"Well, I Met Dr. Agarwal and I like him. He doesn't pull punches and is direct and a very sharp doctor. The drug is TAK-700 but I can't go into too much detail as when I tried to give details and post, I got locked out and re-directed to a IT security link saying to contact them, so all I will say is Dr. Agarwal is trying to improve hormone therapy with this new drug that is more of a targeted attack, and he prefers this to chemo which is more like dropping a nuclear bomb on the cancer. I have a few more tests to pass before being accepted, but so far things look good."

I wonder if you were told details regarding this trial of Orteronel (TAK 700). Is it new?

As far as I know, this drug's phase III trial started in 2010 for metastatic castration-resistant prostate cancer and it was terminated by its owner Takeda Pharmaceutical in 2014, without receiving FDA's approval for its use in PCa. The reason for termination was that the results did not demonstrate significant improvement in extending life, when compared to the placebo group.

The trial was done worldwide in two characteristics groups, with chemo naive patients and none chemo naive patients. Here are details of the trial;

https://clinicaltrials.gov/ct2/show/NCT00569153

Here are the results;

http://www.esmo.org/Conferences/Past-Conferences/European-Cancer-Congress-2015/News/Anti-tumour-Activity-Demonstrated-with-Orteronel-in-Metastatic-Castration-Resistant-Prostate-Cancer

ASCO Journal also published the abstract of the trial findings written by the researchers, including the name of Dr. Argawal. Here is

http://jco.ascopubs.org/content/early/2015/01/23/JCO.2014.56.5119

In any case, these researchers found that Orteronel demonstrated to be effective in inhibiting the manufacture of androgens when in comparison with the placebo drugs. However, patients on Orteronel experienced more side effects than the placebo group.

A similar drug is Zytiga (abiraterone acetate). Its trial results do not differ much from Orteronel. Both are 17-lyase inhibitors (slightly different) and used to attack cancer’s intratumoral activity when it becomes resistant to traditional antiandrogens (such as Casodex). Zytiga was FDA approved for stage IV patients. Another similar drug (P450 inhibitor) and cheaper is Ketoconasol, used for many years by oncologists to fight castration registant PCa.

Probably Dr. Argawal wants you to take Orteronel as a substitute of Casodex but will you keep Lupron (?).

Please let us know details as you move forward.

Best wishes,

VGama

I cross my fingers for your success in the trial. Surely it will be better that you fall into the group of patients taking Orteronel. Bicalutamide (Casodex) is a cheap and easy to take pill (you are already experiencing) but it is not recommended as a solo androgen blokage in risky cases because it only addresses the AR androgen receptors (mouth) of cancerous cells. It works well initialy but after a long period of use (years) the cancer modifies its AR and starts feeding on the Casodex itself.

Enzalutamide (Xtandi) has greater affinity for cell's androgen receptor than bicalutamide prolonging the time of dependency in an ADT treatment but it also fails and it is much more expensive. Dr. Argawal was involved in a trial comparing Xandi agaisnt Casodex.
http://jco.ascopubs.org/content/34/18/2098.full?related-urls=yes&legid=jco;34/18/2098

This time your trial may be similar to the above using Orteronel instead. However, Orteronel is not an antiandrogen like Casodex or Xtandi. Probably the trial intent is to verify if stage IV patients have higher benefit by starting the hormonal treatment with CYP 17 inhibitors, which typically are given only after the patient becomes refractory.
Hormonal therapies weaken the bone so that they will include Zometa to avoid bone reabsorption. This drug may cause hypercalcemia. Chek your lipids timely. 

Thinking of you,

Best

VG