I should be starting this clinical investigation next week. Have been testing the past few weeks to make sure that I qualify for this study and thus far I am scheduled to start next week. I could still receive a call last minute disqualifying me from participation but hope not..
My PSA started to show up again in June of 2018@ 0.07, Jan 2019@ 0.14, April 2019@0.15, July 2019@ 0.25, Oct 2019@ 0.36, Dec 2019@ 0.52
I was off treatment for about 3 years..
Dr Tagawa offered me this Clinical Investigation.
Arm A Degarelix
Arm B Degarelix + Apalutamide
Arm C Degarelix + Apalutamide + Abiraterone acetate/Prednisone
In a random selection I will receive one of these arm's for one year.
Monthly visits to Dr Tagawa for injection and blood work, plus weekly labs.

I am now 48 years old,
Appleseed

“ Androgen Annihilation”

Sounds......like a Rambo movie!

Thank you for doing the trial.

Appleseed
I've been in that trial for 20 months now. I was hoping to be randomized into the Degarelix + Apalutamide arm, but was randomized into the Degarelix only arm. I was on monthly Degarelix shots for a year - May 2018 through April 2019 and have been on break since then. While on break I get monthly PSA and T tests and see my oncologist every quarter. As it has turned out so far, even though I am on standard treatment only, my PSA and T dropped to undetectable within a couple of months. After stopping Degarelix last April, my PSA stayed undetectable or barely detectable for a few months and is now still low but climbing: 0.13 last month, 0.22 this month.

My MO says when to start the next round of Degarelix will depend on doubling time as well as on the PSA number. When I start the next round he expects to add either Apalutamide, Enzalutamide, or AA + prednisone along with the Degarelix. He will also ask for insurance approval for an Axumin PET scan to see if there is maybe something identifiable that can be safely zapped.

Before starting treatment in 2018 I had the CT and bone scans prescribed by the trial protocol. They showed no distant mets but did light up one lymph node that also happened to be pressing on my ureter and beginning to affect my left kidney. The Degarelix returned the node and kidney issue to normal.

My only costs under my Blue Cross Medicare Advantage plan have been $80 to $90 per month in copays while I was on monthly shots and check-ups at Dana-Farber. Since going on break from Degarelix I get tested at my local hospital and go into D-F every third month and my co-pays have been only $30 to $40 per month.

If I do go on one of the expensive new drugs when I start the next round it will not be part of the trial. It looks like copays under my Blue Cross plan will run probably $8,000 or so because they classify these as "tier 4" drugs - meaning I pay 20 percent through the first phase and the "donut hole" and then pay only 5 percent under "catastrophic coverage" after that. Some system!. However I also qualify for VA medical care. With luck I can get it prescribed by the VA if a VA oncologist agrees with my D-F oncologist that it is appropriate.

That's what I know so far. Good luck with the randomization pick. I have a mental image of doctors and nurses going into the next room and playing rock, paper, scissors.
Jim

Hello Appleseed,

I'm thankful that you are participating in this trial. I have heard of Dr. Tagawa, a noted leader in prostate cancer research.

From every trial, something is learned. I feel tremendous gratitude to those who participated in trials years ago that led to medications and treatment approaches that have helped me since my diagnosis in 2013 ... ADT shots, Taxotere chemotherapy infusions, Zytiga, and even Prolio injections to preserve bone strength. My treatment history is shown below my message.

My grandfather and my dad and now I have all been prostate cancer patients, representing three generations of my family. In my grandfather's case, no treatments were available to him upon his diagnosis in the 1970s. We had one last Christmas with him, and he passed away shortly thereafter.

That experience, watching my grandfather fade away with no viable treatments available in that era leaves me indebted to every fellow who steps forward for trials --- it's what it takes for research to advance, and for new treatments to emerge.

In my case, I have agreed to have my treatment history to be added to the Mayo Clinic database, I was in the first wave of fellows who pursued the "early chemo plan" as soon as studies showed a benefit, I was the first patient that my doctor started on Zytiga, and I have undergone two cutting edge genetic tests when they first emerged.

I heartily applaud your participation in this trial. Keep us apprised of your progress and let us know how you're faring, Appleseed!

Handshake from across the miles,
Cyclone - Iowa State University

Guys, So Tuesday I made my way back into the City to Wiel Cornell Presbyterian Hospital to see Dr Tagawa my medical oncologist. Though I did not see Dr Tagawa his team took 8 tubes of blood & I received a double first dose of Degarelix. This means I was randomized for Arm A of the study. I was a little disappointed because I felt that Arm B & Arm C have more potential to knock back the growing cancer cells. But, this is what was chosen for me so I accept my fate.
The injections were put into the fatty part of the abdomen right around the belly button. Within a few hours they crystallize into what look and felt like golf balls, where they will break down over time. Though I was not in pain, it felt uncomfortable like if I had stitches. I am feeling sore and am having some restricted movement. That is the best way I can describe it as of now.

Bohemond Jim, I spoke about your reoccurrence after eight months or so after treatment and one of the young nurses was honest enough to tell me that one of her patients had a similar reoccurrence time. Which only leads me to believe that I will follow suit. But, I will keep an open mind and stay positive.

Cyclone, good to hear from you. I’ve seen you around the form from around the same time that I joined. Thank you for chiming in.
My Grandmother Julia passed away from ovarian cancer in 1986, my Father had prostate cancer, it was taken out and he had no reoccurrence. I was diagnosed with a more aggressive prostate cancer and we have all tested positive for the Broc2

Keep on doing what we do best, living life & being thankful..

..Appleseed Nick..

Nick -
I'm sorry you got randomized into group 1. When time for round 2 comes along - hopefully for a longer interval than I'm having - you should be able to get one of the new drugs in addition to the Degarelix - which is still earlier than patients have been getting it until now.

That first set of shots is actually a triple dose distributed between two shots. The morning after, I told my wife it felt like I came in second best in a knife fight. But after that one the others are easy. They should alternate sides for each monthly shot. They sting a bit for a couple of days but nothing like the first dose.

Mattam - I agree with your logic. I hope it is right.
Jim