Duration of Androgen Deprivation Therapy in High-risk Prostate Cancer: A Randomized Phase III Trial.

I agree Jerry.

At the time, my docs followed the Bolla study that indicated 36 months for high risk. My MO said he thought 18-24 could be as effective, but couldn't cite any study. We (uro, mo and I) mutually concluded to hit it hard and do the third year. No regrets at this time.

Of course with this study it doesn't give any guidance 15-20 years out. It looks like the median follow up was 9.4 years.

Also interesting is that it specifically recommended radiation and ADT for high risk, which is what you and I used, so far, successfully.

It's good they're getting more data on this. ADT duration has always been one of those things that the medical community hasn't had a good handle on...

Now they tell us! I know you went the full three years, Redwing. My guy had a 31-month sentence, and he'll be going back on ADT again next month. Thanks for sharing this for fellas down the road. Four years ago, we looked for stats, checked with Mass General and Dana Farber, and nobody had anything more to say than "more is more," i.e. go longer to be on the "safe side."

As I recall, this result was first announced at a major meeting (ASTRO?), roughly four years ago. It got a lot of press coverage at the time. Glad to see that the results are finally published.
Link to the abstract:
https://www.ncbi.nlm.nih.gov/pubmed/29980331
With respect to CAdogsRus' question, it's been awhile, but the ADT side effects didn't get worse for me with time. Not surprisingly, the hot flashes are easier to live with once it got colder.

Tall Allen said...
Oddly, Nabid et al first revealed these findings way back in 2013. I have no idea why it took so long to get published.

/prostatecancerinfolink.net/2013/02/13/18-months-of-adt-as-good-as-3-years-when-combined-with-radiation/

Sadly, the radiation dose to the prostate was only 70 Gy - too low based on current findings. We have DART 01/05 saying that 28 months is preferable to 4 months in high risk patients with escalated radiation dose. here's what we know so far:

/pcnrv.blogspot.com/2016/08/androgen-deprivation-therapy-adt-and.html

As you already pointed out, DART (4 months vs 28 months) is significantly different from the Nabid et al. trial. And if the Nabid et al. trial would ever be repeated at higher dose (I doubt it ever will), I would expect the outcome (18 months is as good as 36 months) to be similar, based on biological reasoning/intuition.

Tall Allen said...
To me, the question for high risk men is: do you want IMRT with at least 18 months of ADT and a milder side effect profile, or do you want brachy boost therapy (with no clear benefit to adding ADT) with a higher risk of urinary side effects? I believe patients are fully capable of making these decisions for themselves.

Huh?

I'm not going to searching for the link to the study you had on your blog, but there was a clear benefit for high risk with "triple play" of RT + BBT + ADT -- or did I misread or miscomprehend?

Tall Allen said...
To me, the question for high risk men is: do you want IMRT with at least 18 months of ADT and a milder side effect profile, or do you want brachy boost therapy (with no clear benefit to adding ADT) with a higher risk of urinary side effects? I believe patients are fully capable of making these decisions for themselves.

That Allen, is exactly the quandary for many high risk men, and in the end they have to make the call and live with it.

CAdogsrUs- the benefit was an oncological benefit - it did a better job of getting rid of the cancer. But the patient also cares about the SEs of treatment. with the higher multi-modal doses comes a higher risk of late term urinary problems.

Balladeer- 6 months of HT may be in part due to your having a large prostate that has to be shrunk before the seeds are put in? That doesn't have to be done if he were doing HDR-BT rather than seeds. If you chose EBRT only, you should have at least 18 months of HT starting 2 months before EBRT. Expected urinary side effects are lower with EBRT-only, but so is the expected oncological benefit.

LifeCointosses - I have never met a patient who couldn't understand those trade-offs. Most high risk men I've met (at least the ones who show up in my support groups or online), if they get past their initial urologist, want to know more. To most high risk men, curing the cancer at almost any cost is paramount. Some guys want the extra insurance ADT provides; some guys are ADT-averse.

Tall Allen said...
Balladeer- 6 months of HT may be in part due to your having a large prostate that has to be shrunk before the seeds are put in? That doesn't have to be done if he were doing HDR-BT rather than seeds. If you chose EBRT only, you should have at least 18 months of HT starting 2 months before EBRT. Expected urinary side effects are lower with EBRT-only, but so is the expected oncological benefit.

TA - Yes, my RO indicated that my prostate volume (50cc) was near the upper edge of qualifying for LDR-BBT, and that (as you've suggested here), the combined casodex, then lupron treatments should effectively shrink it to a point that would be fully acceptable (maybe 40cc or less?).

However, just to be clear, he indicated that his own internal (institutional) data for such high-risk patients choosing the triple-play (BBT+IMRT+ADT), supported no more than a "total" ADT period of 180-days. That's 1-month of casodex, followed by 2-months of lupron, followed by LDR-BBT at 3-months, followed by IMRT at months 4-5, with continued lupron for only 30-days post-IMRT = 180-days total. He stated that this decision was based upon a 15-year history with 3,000+ patients, and that the data was currently under peer-review for publication in the near future.

That said, it remains unclear to me at this point, why the LDR-BBT phase of the treatment is scheduled to occur 'before' IMRT, rather than 'after' it, and, since I am not a low- or intermediate-risk patient, it also remains unclear to me why the 'LDR' (rather than HDR) approach is being proposed in my case. I hope to get answers to those two questions soon, but the RO is out-of-state and not readily accessible.

Thanks again for your clarification.

Tall Allen said...
Here's what we know so far about whether ADT is still necessary with BBT. As you can see, it had an effect in only 1 of 7 studies. But shrinking the prostate prior to seeds is certainly a way to cut down on side effects, and your confidence in the procedure is sure to be greater when you go in for a longer ADT schedule:

/pcnrv.blogspot.com/2017/12/is-adt-still-needed-for-high-risk.html

It doesn't really matter if seed placement is before or after EBRT. They have to wait for swelling to go down after BT, and with Pd-103 seeds, they should wait about 3 weeks before beginning EBRT. There is no appreciable difference in using HDR-BT or LDR-BT. You should go with whatever your RO has more experience with.

Excellent! I believe the bulk of his experience swings towards LDR (not HDR), and I think his current plan is to begin IMRT roughly 4-weeks after LDR-BBT, so that all jives, and you're right - I don't imagine he'll have any objections to extending the ADT treatment period, should I choose to go that route. Don't know for sure, but I get the impression that he would rather cease the ADT at 180-days, and then cautiously monitor the PSA thereafter for any spikes, before resuming ADT again.

CAdogsRus said...
Balladeer: Just curious where you are being treated.

I meet with my UCSD RO next Wednesday and hope to receive the ok for BBT and LDR-BBT after hopefully good enough uriflow and retention test results [yesterday's retention measured 124 mL (down from 300 mL two weeks ago) after 2 weeks of 5 mg Cialis tablets].

CAdogsRus:

I'd really prefer to keep the doctor and the facility in confidence at this point, as none of the radiation treatments have occurred just yet, and I'm still a bit undecided on some things. Also, I don't want to risk misquoting him on something that he or his staff have said or advised. However, I'll be happy to do so once the treatments have actually begun and I've got his approval to relay such things here on-line, which should be late next month sometime.

As for the uriflow and retention tests, I've not been advised that I'll need such tests prior to BBT, but it makes perfect sense, so I wonder if that's something that will still surface in my lone preparatory (pre-op BBT) meeting? No telling. All-in-all, my urination frequency doesn't seem to be too bad (barely one visit to the restroom most nights), but I pee fairly frequently during the day (when fluid intake is typically increased), and I sense that in those instances, I too may be retaining a fair volume of unvoided urine in the bladder after each visit. Hopefully, it won't present a problem going forward. I've got bottles of Tamsulosin (Flomax) and Alfusosin sitting here, that I've never bothered to take, so I guess I could start one of those just to be safe (?), but my insurance recently denied a script for 5mg Cialis, so I'm outta luck on that one!

Anyway, good luck with your bladder tests on Wednesday, and best of luck with the impending BBT+IMRT regimens.

CAdogsRus said...
Balladeer: No worries on where you plan to be treated. I think I was told IMRT then seeds. But TA has said order doesn't matter, but I will ask out of curiosity next week.

I had slow urine when I got the DX. That's when I was told I would need flow and retention tests before seeds would be offered. A prescription of Flomax after seeing RO got flow sped up right away. No testing was done (flow/retention) until two weeks ago. Flow was judged to be fine after first test. I hope retention now is judged ok -- don't know yet.

Second 3 month Lupron in 10 days -- that will be fourth appt in 11 days, a good prep for IMRT visits ;)

Yup, beam then seeds (not seeds then beam), appears to be the industry norm, and from what I can tell (including what TA has posted here earlier), there really isn't any evidence to support one sequence over the other. Common sense (which I suppose can be misleading at times), would seem to indicate that irradiating small metallic objects already present in the prostate (i.e., Pd-103 seeds), wouldn't be too desireable, but what the hell do I know? Haaaa!

As for your Lupron history, wow, that's kinda surprising to me that you've been on it that long (i.e., 6-months prior to BBT?), although I suppose its a matter of more is better than less in this instance. With six-months of full-on T-deprivation, the prostate cells should be nicely sensitized to the impending back-to-back (internal and external) radiation treatments.

Anyway, the very best of luck to you with it, and please keep us posted on your progress. You and I have some notable similarities, so I'll definitely be following your journey with interest.