Anyone in Clinical Trail NRG-GU009?

[OldVTGuy]

My RO says I am a candidate for this but I am not positive I want to participate.

I am leaning toward ADT+IMRT+LDR PB Boost for a G9 contained to the prostate.

Help me with my analysis:

Positives:

1. If I ended up being a high DECIPHER risk gives me access to Apalutimide right away.

Negatives:

1. Not sure I can see that 24 months of Apalutimide concurrent with 24 months of ADT isn't overkill with my situation .

If I am in the low risk group I could be given 24 months of ADT and again, given the results of the ASCENDE trial I am not sure this is not overkill also.

What am I missing here. Thanks.

[Jancapper]

If I was in your situation, I would request the same treatment I received. Your 12 positive cores with GS 9, with cancer extending from the apex all the way to the base, and PSA > 10, place you in the high risk category. I would welcome the most intense treatment offered to me. Prior to my treatment, my urologist completed a 4k test. Those results indicated that I have a 19% chance of my cancer being aggressive or an 81% chance of being non-aggressive. My urologist even inquired if I was a betting man. If so, I could actually select watch and wait. This did not sit well with me. I requested a TRB ASAP. Sure enough, pathology showed Gleason 9 cancer in 3 cores. I had my mind determined that RARP was my best choice. However, the same urologist informed me that the best chance for survival was 2 years of ADT + HDBT + IMRT. I read and investigated this treatment endlessly, eventually selecting it as my choice. My RO started me on 3 months of neo-adjuvant ADT. I am one of the lucky ones. I have experienced zero side effects thus far. Moreover, I have experienced a good initial response to my ADT. PSA started at 14.5 and just prior to receiving my HDBT, it fell to 0.34. I received my HDBT on November 30, 2022. It was more difficult than what I had anticipated. The pain experienced while urinating after surgery was intense. Fortunately, this lasted only 2 days. Then diarrhea set in for the next 3 days. Not fun. Finally, a big old hemorrhoid then emerged. Another 5 days of discomfort. However, all issues resolved spontaneously without treatment. Two weeks later, I began my 25 sessions of IMRT to pelvis. Today, I completed my 11th treatment. None of this easy or comfortable but it does offer me the best chance of survival. If this therapy results in long term remission, it will have been well worth it.

I see that you are leaning towards the LDBT. Many institutions no longer even offer this. The HDBT is a key component to the success of my treatment. Additionally, for Gleason 9 cancer, ADT should be administered neo-adjunctively before your radiation begins. At a minimum, 3 months which can be extended all the way up to 1 year. This slows and weakens the cancer cells with the additional benefit of sensitizing the tumor.

Best of luck regardless of your choice of treatment.

[OldVTGuy in reply to Jancapper]

Thanks - Brachy may in fact be HDBT as its not specified in the initial plan I received (just says Brachy Boost). Probably a bad assumption on my part.

I am more interested in the clinical trail and should I join. I expect otherwise I will have the same treatment as you.

[Jancapper in reply to OldVTGuy]

Yes, my treatment is officially described as IMRT + High Dose Brachytherapy Boost with neo-adjuvant ADT.

[Adendino in reply to Jancapper]

Jancapper, Did you have ECE or SVI?

[OldVTGuy in reply to Jancapper]

Actually I went back and looked at the proposed plan by the RO and it very clearly says LDR Brachy. In researching this I can across this PCRI video youtube.com/watch?v=9OBQNjo...(Not working as expected?)

and I think I see why it may be recommended for me. My lesion is contained in the prostate so I'm thinking my doc believes its appropriate. Will certainly ask at my appointment this week. Thanks for bringing it up as I did not realize there were two types until now!

[Jancapper in reply to OldVTGuy]

The high dose brachytherapy portion of my treatment is a critical element of it’s potential success. Prostate cancer has a low alpha/beta ratio. This can be effectively dealt with by administering high fraction doses of radiation. A single session of delivering a 15 Grey dose via HDBT, delivers a biological effective dose of around 90 Gy to the tumor. My cancer too is confined to the capsule. However, having GS 9 elevates the seriousness of the tumor. Whole pelvic radiation as well as ADT are administered in an attempt to snuff out any micro Mets that may be present but still to small to see on scans, including PSMA scans. I have read just a few days ago, that HDBT has clearly demonstrated it’s superiority that some institutions no longer even offer LDBT. There are a few contraindications for the HDBT, ie, prostate volume >50 ml, unsuitable for surgery, lack of skill by the RO, etc…

Best of luck to you.

[OldVTGuy in reply to Jancapper]

Thanks. My hospital offers both so I have lots of questions to ask in terms of recommended treatment.

[Jancapper in reply to OldVTGuy]

I have a ton of papers on this. If you need anything for reading, just ask. There are a few right here on prostatecancer.news

[Jancapper]

No, clear of ECE, SV, Mets and lymph nodes. Although I recall this therapy is still indicated when SV+.

[Jpl506]

I was G9 had SBRT and 26 months ADT+Apalutimide completed May 1 2022. Going in it seems like a long time but it passed quickly. It wasn’t such a big deal, I walked a lot and lifted weights. Didn’t gain weight and ended up in the best shape I’ve been in in decades.

[Tall_Allen]

There are really two trials depending on the result of your Decipher score.

(1) If your Decipher score is low, you are randomized to either 1 or 2 years of ADT.

(2) If your Decipher score is high, you will get 2 years of ADT, randomized to get or not get apalutamide with it.

Trials have shown that, independent of Decipher, 2 years of ADT are necessary with IMRT, or 1 year with Brachy Boost therapy:

prostatecancer.news/2022/01...

ASCENDE-RT used 8 months of neoadjuvant ADT to universally shrink prostates, and 4 months concurrent and adjuvant ADT. Late-term urinary side effects were high, though. Recent evidence suggests that only the concurrent and adjuvant ADT is important.

The AASUR trial showed that adding 6 months of Zytiga+Erleada could improve results if SBRT alone was used.

prostatecancer.news/2021/06...

A recent STAMPEDE trial that adding abiraterone to two years of ADT could improve outcomes.

ncbi.nlm.nih.gov/pmc/articl...

[OldVTGuy]

I am leaning toward the Brachy Boost route and not the trial. Following in Jancapper's footsteps it seems.

[OldVTGuy]

UPDATE - My DECIPHER came back at 0.98 however I ended up on the "non-Apalutimide" arm of the trial. Therefore I will receive 2 years of Lupron to go with my 44 sessions of IMRT. I am now one month into the Lupron and no side effects so far. Fiducial placement next week, radiation to begin 3/20.