Standard of Care for Stage IV mHSPCa

[6357axbz]

Is there a definitive SOC for Stage IV mHSPCa (mets in the bone)? I thought I knew the answer but my experiences seem to contradict what I thought I knew. Thanks

[Tall_Allen]

There are several options in the US now (and enzalutamide and apalutamide will join the list in a few months):

pcnrv.blogspot.com/2017/06/...

[6357axbz in reply to Tall_Allen]

So IMRT to prostate is not SOC and would not be covered by insurance?

[Tall_Allen in reply to 6357axbz]

It depends. Read the sections "Early use of Debulking" and "High volume/low volume of metastases"

Also:

pcnrv.blogspot.com/2018/09/...

[6357axbz in reply to Tall_Allen]

Ok, Thanks

[6357axbz in reply to Tall_Allen]

Ok I’ve read those. But it doesn’t explicitly define SOC. Reason I’m asking is because my impression of the trial I’m participating in, for mHsPCa oligometastatic Patient’s, is that SOC would not include IMRT. My randomization to control group is receiving, IMRT to prostate, (a debunking option) that all men in the control group receive, and so based on my understanding of SOC, I’m getting extra treatment that I could not have received had I stayed with SOC which would only pay for ADT cause “the horse is already out of the barn”, and not IMRT . had I been randomized to the “extra-treatmentgroup I would hav also received zaps to my oligometastatic mets.

[Tall_Allen in reply to 6357axbz]

Those treatments that I discuss are all SOC in the US. Sorry, your post confuses me. You make the following statements which seem to be contradictory:

• "the trial I’m participating in, for mHsPCa oligometastatic Patient’s, is that SOC would not include IMRT"

• "My randomization to control group is receiving, IMRT to prostate, (a debulking option) that all men in the control group receive"

• "I’m getting extra treatment that I could not have received had I stayed with SOC which would only pay for ADT cause “the horse is already out of the barn”, and not IMRT "

If you're in the control group, you are receiving SOC [that's what controls usually are]

Then you state, "had I been randomized to the “extra-treatment group I would have also received zaps to my oligometastatic mets." Metastasis-directed therapy is a completely different thing from prostate-directed IMRT (debulking). It is not SOC.

Also, SOC depends on the start date of the trial - the MD Anderson trial of debulking + metastasis-directed therapy, for example, does not include debulking for oligometastatic PC as SOC. There may be other rules specific to the trial.

Perhaps it would be easier if you tell me which trial you're talking about.

[6357axbz in reply to Tall_Allen]

My apologies for the confusion.

Study #2018-0349

EXTernal beam radiation to Eliminate Nominal metastatic Disease (EXTEND): A randomized phase II basket trial assessing the efficacy of upfront local consolidative therapy (LCT) for oligometastatic disease

Dr Chad Tang (MD Anderson) is the principle investigator. This trial is for many types of cancer, not just prostate cancer.

My thinking going into this trial was that if I didn’t get randomized to the “extra treatment” side, which for my oligometastatic HSPCa would include zapping individual mets, I would still get IMRT to the prostate (and in my case, seminal vesicles) and that would still be beyond SOC for my PCa. In other words I would be getting more than SOC regardless of which side of the randomization I landed on. My understanding entering the trial, which I’m now questioning, was that SOC for my mHSPCa was ADT only and that even if I was randomized to the “non-extra treatment side”, which was the case, the IMRT I received was still beyond SOC.

[Tall_Allen in reply to 6357axbz]

Thanks - that helps. Here is the description:

mdanderson.org/patients-fam...

clinicaltrials.gov/ct2/show...

So the control group gets SOC systemic therapy (but not any local therapy), which probably means abiraterone + Lupron.

The treatment group gets that plus radiation to the prostate and radiation to the oligometastases (local therapies).

Outside of the study, you can probably get SOC systemic therapy and radiation of the prostate (if your insurance allows it). SOC does not include radiation of oligometastases to extend survival, although, with pre-authorization, some insurance may allow it anyway (radiation for pain palliation or fracture prevention are SOC).

[6357axbz in reply to Tall_Allen]

Thank-you. My understanding of the written description as I reviewed the consent documentation was the same as yours TA. In fact I sent an email to Dr Chad Tang’s assistant because the written description didn’t agree with what I had been told when I first met with Dr. Tang and he verbally described the trial to me. Here’s the email I sent:

“Kels,

I was reading the paperwork I received from Dr Tang regarding his study we discussed. It was our clear understanding that the control group would receive hormone treatment PLUS IMRT. The 2nd group would receive that PLUS (in my case) radiation of the tumor in my pelvis and ribs. Did we misunderstand?”

To which he responded:

“That is correct. There are two arms to this randomized clinical trial.

· Arm 1 – radiation to your prostate only with the continuation of hormone therapy

· Arm 2 – radiation to both your prostate and metastatic disease with the continuation of hormone therapy”

He later told me they needed to re-write the consent description because, as written, it didn’t properly describe the trial as it applied to prostate cancer (the trial covers many other cancers besides PCa).

So I think Dr Tangs idea of SOC systemic therapy is shaped by the results of STAMPEDE trial as detailed in the Lancet article, “Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial” which showed good results when radiotherapy to the primary tomour, was combined with ADT for oligometastatic men.

I have now completed the IMRT to my prostate. As I previously said I got randomized to the arm that does not, immediately get mets zapped. As part of the trial I will take a break from my ADT (Zytiga/Lupron) when my current 6 month injection wears off. My PSA will be monitored monthly until my PSA rises back up to about 2 (currently at 0.2 and dropping). At that time Dr Tang will zap my mets.

As I think you are aware there is another PCa trial (BST) at MDA by Dr Brian Chapin in which the control arm gets ADT only and the other arm gets ADT plus either radiation to the primary tumor or RP. I was offered that trial but when I first met with Dr Tang I realized I’d get more treatment in his trial even if I were randomized to the “control” group, so that’s the way I went.

RA

Sent from my iPhone

[cigafred in reply to Tall_Allen]

Medicare paid for my radiation to para-aorta and common iliac metastases.

[6357axbz in reply to cigafred]

Thank-you

[CantChoose]

Our MO told us it's personal preference between chemo or Zytiga. As TA said, it's likely that Xtandi and Erleada will be on the list shortly as well. She said the curves are virtually identical with regard to outcome, so it comes down to personal preference or individual physiological quirks.

My husband already has chronic hypokalemia and low hemo, so we're trying the chemo first, since Zytiga is known to impact both of those things. Thought we'd try some new side effects this time.

[tango65]

The SOC is ADT plus chemo or plus Abiraterone with prednisone. There is not difference between both tretments:

ncbi.nlm.nih.gov/pubmed/295...

In patients who are oligo metastatic radiotherapy to the postate may offer a survival advantage:

academic.oup.com/annonc/art...

[j-o-h-n]

75 years ago today those brave men saved our freedom, now don't let it dwindle away from us.

Good Luck, Good Health and Good Humor.

j-o-h-n Thursday 06/06/2019 5:50 PM DST

[Break60]

I’m in Normandy celebrating their accomplishments! Awesome!

[Break60]

It’s not “SOC” per se but I’ve used ADT plus SBRT to specific oligomets. Since January I’ve switched to estradiol patches only and plan on staying with them until/if I become CR.

[JimVanHorn]

I was told that radiation kills off a lot of bone metastases and keeping low numbers of Testosterone keeps it from multiplying. Single cells come out of the prostate all the time and mos are killed off by our immune system. They have a affinity (meaning that is where they like to go) for bone tissue and lymph nodes. A cancerous cell will attach to a bone, sit there for a while. begin to enter into the bone (leaving a pock mark like an acne scar) and as long as there is no testosterone it is stuck there until it dies. This weakens the bone an occasional injections of Xgeva (osteoporosis drug) keep the bone from becoming too brittle. A bone density test helps know the health of the bone. Lymph nodes require chemical agents to stop their progression plus watching T-cell counts of white blood cells that can help kill off PCa cells.

[Life5 in reply to JimVanHorn]

HI

Could you please clarify Lymph nodes require chemical agents to stop their progression plus watching T-cell counts of white blood cells that can help kill off PCa cells. Does this mean apart from Zytiga and Prednisone (which basically block t- production from androgen glands) - for lymph node mets some other chemical agents are also required?