Friend on TRANSFORMER trial, Xtandi not working.

My friend has metastatic castrate-resistant PCa. He failed Lupron after two years, then had a good 14 month run on Zytiga before it failed, then a couple months ago entered the TRANSFORMER trial (compares Xtandi to BAT). He was randomized to the Xtandi arm, and has been on it for about two months.

Last night, he reported his PSA has gone up from 47 a month or two ago to 64 now, so it seems the Xtandi isn't actually working. He says he'll meet with his oncologist in the next couple of weeks. It's likely they'll cross him over to the BAT arm, allowed by the trial's design. I'm going to talk to him, since I think he's had some symptoms of bone pain from mets in his femur already, and I know that's a significant issue against trying the high-testosterone BAT cycle. He may want to do it anyway, I don't know.

[Edit: Upon rereading, a "high-testosterone BAT cycle" sounds like a blast - I gotta get me one of those!.]

He isn't one to do much research on his own. I should know this from all the threads here, but is there anything new after failing both of the 2nd line hormonal therapies? Usually it seems docetaxel is next. I did find this article, which I plan to share with him:
Drugs That Offer a Survival Advantage for Men With Bone Metastases Resulting From Castration-Resistant Prostate Cancer

He's rather distraught about the whole thing, as you can imagine. His first grandchild is due in August, and he's said he wants to be around long enough for the little one to remember him (4-5 years old?). Kind of breaks my heart, since with mCRPC this far along that's pretty unlikely. Possible, but low probability.

This disease really sucks.

Hello Redwing...Please keep us informed if they switch him to BAT and if he accepts that treatment at this point..

Thanks, Allen. He's actually on the trial through the University of Michigan. I hope they're tied in well with JH, but I don't know how that works. I'd like to think they're proactively making a personalized plan. My experience there has been closer to the "read your chart on the way in the door" approach. I don't get a feeling that there's much strategic thought involved.

My concern with his bone pain possibility is he may not be as forthright as he should be about it with the study team. I'm concerned he may be discounting it in the hope of having some sort of benefit from the trial. That worries me.

I'll suggest he discuss such docetaxel+ trials, and see if his onco is guiding him in that. I'm concerned enough about him, and his mindset, that it might be worth offering to go with him to his appointment. Not sure what he'd say about that.

The University of Colorado is also participating in the TRANSFORMER trial..Half the people who sign up get Xtandi and the other half BAT. I'm going to talk with them in a week or so..But I'm not really interested in being in the Xtandi arm, that's pretty much been investigated in guys like me....

Update on my friend's situation - it's not very good. He had a CT scan and a T99 bone scan yesterday.

He's been on Xtandi for a couple of months now, without apparent effect. His PSA is doubling monthly, now at 90 or so. He has a couple of new bone mets this month, and two lymph nodes near his kidneys have doubled in size. With this level, and that doubling rate, he's running out the clock pretty fast. (I've seen studies indicating a dangerous tumor load at about 1000 cc. With a G7 putting out maybe 3 ng/ml per cc, that suggests a PSA of around 3000+ becoming quite serious. That's only about 5-6 months at this doubling rate if unchanged.)

His oncologist and he decided to switch him to the BAT arm of the trial, with his first testosterone injection in two weeks. I'm rather concerned, since he says he's experiencing "mild" bone pain now, managed with ibuprofen. He's had painful shoulders, but the onco thinks it's arthritic (I assume from no activity on the bone scan). I don't know for sure if he's been forthcoming with his oncologist about that, but we've sure talked about it and he knows the risk. Bone pain was a disqualifier for that study.

I don't know... if it was me, I'm pretty sure I'd bail on the study, and go to the accepted next step of docetaxel chemo ASAP. If he persists with the BAT arm, he'll get the injection in a couple of weeks, and then wait to see the effect for another month, maybe two? With his present situation, that seems to be waiting a long time before the next step of docetaxel if the BAT isn't effective. On the other hand, maybe it will help!

Of course, we wouldn't have some of the newer treatments without courageous guys taking just such a chance. Still, it's a difficult situation.

I'll update whenever I hear more.

Redwing - I'm with you - chemo would probably do him a world of good. There's an irrational fear of chemo that many guys have. The tragedy is that it works best and has fewer SEs if used earlier, but many wait until SEs are inevitable.

Jack that is a good suggestion. We talked about Provenge last night too, and he had reviewed the possibility during his onco visit. He was still pretty unfamiliar with it though we had discussed in the past. He's not a "technical" person!

He's at least "mildly symptomatic". He already broke his hip two years ago due to extreme bone weakening from the metastases. So, along with some bone pain significant enough to take an NSAID for it, I would say he's shown some clear symptoms.

U of M is a problem for Provenge, as his onco there said "We don't do that, you'd have to go somewhere else.". I don't know where in SE Michigan they do that. I'd be interested in a name, if anyone has one, that I could pass along to him. He is at least now pretty active in pursuing treatment options.

In my understanding, the draw is a bit like donating plasma. The blood is drawn from one arm, processed, and put back in the other arm so it requires some specialized equipment. The blood is sent away to some regional facility for the treatment process, then returned for reinsertion. I understand the reinsertion is pretty easy, just a one way process.

While he's on the TRANSFORMER trial he certainly won't do it, so I have a few weeks to work on him about it! It makes me a little uncomfortable to contradict his doctor's advice, but I have been rather openly sharing the options and "what others might do in this situation".

I do get the "why not give it a shot" idea with BAT, but considering how frightfully aggressive his case is the lost time worries me.

Thanks, Allen!

Update - I spoke with my friend yesterday.

He had the first testosterone injection Tuesday a week ago. That night, he developed a low fever, and had quite a bit of night-sweats. He felt better the next day.

A number of his smaller achy spots all quit bothering him, not completely sure if they were all mets or not. His hip, replaced after a fracture and still with nearby mets damage, is bothering him some. But that hip has been a problem all along, so he's not sure if it's really worse from the testosterone or not.

Overall, nothing very serious after the first week. Curiously, they said they only gave him enough testosterone to "bring him up to normal". I thought the idea was to blast the system with nearly double the "normal" T level. Not sure what's up there. There's no objective feedback yet, no scans, no PSA. Probably do something at the next treatment session, but not sure.

He'll wait another 3 weeks or so, and then at 30 days get another testosterone shot. They have already discussed chemo a little bit as the next step if this BAT protocol doesn't work well enough.

It's a little hard for me to learn much from him, since he's totally not technically oriented. He asks the doctors very few questions, and can't relay the results of much of anything that he's told. Completely the opposite approach from mine, but to each his own. Some like to know less, some like to know more.

I applied to be included in the TRANSFORMER trial but was refused for some pretty sketchy reasons..To check for bone mets, they used my latest F-18 bone scan which my Onco said came back clean, no mets found. But the people doing the trial used their own "expert" radiologists to analyze my scan and they found several several "suspicious" areas but could not make a determination if they were mets or not...They said the F-18 scan produces too many false positives and they are not comfortable with it..They want me to have another bone scan in a few months, this one just the standard run-of-the-mill bone scan that they feel more comfortable with, at least for the purpose of being admitted to the trial..They will reconsider my application at that time.....

Translation: The trial is not going to pay for a new bone scan, see if you can get your own insurance to pay for it and let us know....

Jerry,
I just read this thread. Somehow I missed it the last time around. I am wondering what your friend thinks about having a few rounds of chemo? Just my opinion, but it seems staying in this trial right now is putting him at risk for things getting out of control in a hurry.
I hope he gets to spend a whole bunch of time with that grandbaby when it arrives.
Beth

Redwing57

I had Chemo ( Doceataxel ) within a month a being diagnosed, It was every three weeks for 6 times. Hope your friend gets better.

Mike

Has the TRANSFORMER trial been terminated? I was hoping to get into that one...It's too bad it didn't work for your friend...

Sometimes BAT will "reset" the clock and the Xtandi might work again..It's worth a try..Failing that, he could give Zytiga a chance, sometimes it will work even after a patient fails Xtandi..

Provenge might be an option he could explore, some men get a nice remission with it...And of course, the Chemo..How old is your friend and does he have a decent quality of life now?