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Scholz, Moyad- Is Xtandi useful for Active Surveillance?

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Posted 8/27/2014 9:06 PM (GMT 0)
I was reluctant to post this because it's only based on a single case, but a lot of members use Scholz and many remember Mark Moyad from his hosting of PCRI conferences.

Scholz treated a 77 y.o. man who was diagnosed with a GS3+4 prostate tumor found using CDUS. The patient did not want Active Surveillance, nor did he want local therapy. They gave him Xtandi (80 mg/day increased to 120 mg/day). After 6 months of treatment, the tumor shrank from 11.5mm x 3.7mm to 5.3 x 1.7mm, and PSA became undetectable. As of 6 months after the treatment, the tumor stayed small and PSA rose to 1.7. The authors suggest a clinical trial.

You can download a full text of their write-up at the following link:
Short-term enzalutamide treatment for the potential remission of active surveillance or intermediate-risk prostate cancer: a case study, review, and the need for a clinical trial

There are certainly a lot of questions raised by this case:

  • Did the Xtandi therapy delay progression significantly?
  • Are the side effects (e.g., libido loss) worth it?
  • Does Xtandi treatment encourage castrate resistance?


A recent study showed that primary ADT therapy had no survival benefit in men with PC, and only a small benefit among men with highest risk. If that is the case, what is the benefit of treating intermediate risk men with Xtandi?

Effectiveness of Primary Androgen-Deprivation Therapy for Clinically Localized Prostate Cancer

Perhaps a less drastic and certainly less expensive alternative would be to use Proscar/Avodart to extend time on AS. In a study among very low risk men with BPH, 54% had no positive cores detected on f/u biopsy. This, in spite of prostate shrinkage which should make detection easier.

- Allen
Posted 8/28/2014 2:42 AM (GMT 0)
Allen - Your second general question about libido loss is probably not that high on the wish list of the 77 year old.

BTW, it took a while but I finally got the second PSA increase I needed to qualify for Provenge, despite very low PSA. In July PSA <0.04, on Aug 12 PSA = 0.04 and on Aug 26 PSA = 0.05 thanks to a 25 mile bike ride the day before.

It also appears there may be a foundation willing to cover the travel expenses (since income < $150,000) of 3 weekends in Marina del Rey, flights from Tampa etc. Not sure how much the per diem is, but much appreciated.

So looks like I will be out your way quite a bit for next 2 months

Sept 4 gold fiducials 1 PM & CT Scan 2 PM plus Appt with Dr Turner 4:10 PM
Sept 5-7 PCRI - will stop by Tony Crispino's booth and say hello to you

Sept 19 first Provenge cell collection
Sept 22 first Provenge infusion

Sept 24-29 GFMPH Rochester NY

Oct 3 second Provenge cell collection
Oct 6 second Provenge infusion
Oct 6 first of 5 SBRT at UCLA Westwod
Oct 8 second of 5 SBRT at UCLA Westwod
Oct 10 third of 5 SBRT at UCLA Westwod
Oct 13 fourth of 5 SBRT at UCLA Westwod
Oct 15 fifth and final SBRT at UCLA Westwod
Oct 17 final Provenge cell collection
Oct 20 final Provenge infusion

Thanks again for your mentoring. If this schedule holds, it should maximize the abscopal effect

prostate-cancer.org/abscopal-effect/

Back on topic, with respect to "ADT therapy had no survival benefit in men with PC, and only a small benefit among men with highest risk."

Thankfully too early to tell about survival benefit, but Lupron has definitely shrunken my prostate from 48.4 to 31.6 and that TRUS was six months ago, and eliminated my former bone metastases.

Impossible to know if that translates to a survival benefit but one would think it can't hurt, except for the analogous point you made in general comment #3 - Does Xtandi treatment encourage castrate resistance?

On your first general comment "Did the Xtandi therapy delay progression significantly?" Again when he is 77 years old, every increment helps, as does every excrement:}

LupronJim
Posted 8/28/2014 3:57 AM (GMT 0)
Jim-
Great about the assistance, and I'm looking forward to seeing you again in LA - at PCRI and for your (hopefully) final treatment.

Unlike you, the man in their case study was what is called "favorable intermediate risk," so the question is what would have happened had he not had the Xtandi. It's not at all clear that there was a net benefit. Only a randomized controlled study can determine that, which is what Scholz is calling for.

I just hope men don't see the single case and go off half-cocked requesting 6 months of Xtandi on their AS. It's a very powerful AR blocker, and despite Scholz's reassurances of safety, is likely to have unpleasant SEs. It's a great drug if you need it, but why mess with it if there is no clear benefit?

lol@excrement

- Allen
Posted 8/28/2014 4:01 AM (GMT 0)
That's very interesting. Sounds like something that should get a clinical trail.

and that's always the trick - balancing benefit vs unwanted side effects.
Andrew
Posted 8/28/2014 5:03 PM (GMT 0)
Insurance companies are likely to refuse to cover $150,000 Xtandi when $2000 Lupron works better.....
Posted 8/28/2014 9:06 PM (GMT 0)
I know of several trials being encapsulated looking at enzalutamide for the possible role in active surveillance cases. Lupron has already been looked at in that setting and it was determined to be "too strong" for the job with far too many SE's.

Again, remember, this is a very unique setting. Do not compare LHRH agonists with Enzalutamide in this setting. It's apples and oranges. The hypothesis is to see if enzalutamide can make dormant early stage PCa and if not then delay treatment for many years.
Posted 8/29/2014 2:40 AM (GMT 0)
Jim,

Awesome news on the Provenge...good deal..
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