Phase II randomized study of neoadjuv... - Advanced Prostate...

Advanced Prostate Cancer

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Phase II randomized study of neoadjuvant and adjuvant abiraterone acetate+ ARN-509 for intermediate-high risk prostate cancer


Hi All,

I'm 47 and was just diagnosed with prostate cancer in 6 of 12 cores. Gleason 9 in one core. Gleason 7 in 4 cores. Gleason 6 in one core. Bone scans and MRI are clear.

I'm thinking of joining this neoadjuvant trial at Dana Farber in Boston: It includes 6 months of ADT prior to prostatectomy. Arm 1A gets Lupron + abiraterone acetate + apalutamide. Arm 1B gets Lupron + abiraterone acetate. Has anyone heard of this study? What do you think? I'm inclined to hit this hard. Are there other treatments that I should consider?

Thank you all!

16 Replies

Hit it hard, shrink it, jerk it, sounds right to me.


I think it's a good subject to study. Zytiga has demonstrated efficacy in men newly diagnosed with mets, and apalutamide was approved for use in non-metastatic men who are already castration-resistant. Will they add any extra benefit in high risk men, or will they just compound toxicity? Docetaxel was recently shown to confer little or no benefit when used adjuvant to RT for high risk men. it's anyone's guess as to whether these hormonal agents will do better. It is possible that they may only confer a benefit on cancer that has evolved to a certain state. No one knows.

I think the trial precludes your having brachy boost therapy, which is unfortunate. Brachy boost therapy has been proven to be more effective than IMRT alone. It should be considered the gold standard for the RT treatment of high risk men:

I would have preferred to see a randomized clinical trial between IMRT+apalutamide+Zytiga compared to brachy boost therapy. Brachy boost does come with higher risk of urinary side effects, but the advanced hormonals add side effects too.

My PSA and bone scans have been clean 5+ on Lupron and Xtandi. I took many supplements in the first 2.5 years before the clinical trial on Xtandi or Xtandi and prostvac ( a fowl pox vaccine). It was a 2 arm trial at NIH. Since I got in the 'Xtandi alone' trial (also, always on Lupron), prostvac has been pulled for now. I can continue on Lupron and Xtandi ( with an occasional Zometa treatment ) or pull out of the study at NIH. They think I'm doing great 3 years on Xtandi and a PSA of .02. I wonder , though, if I'd be better off getting another type treatment. After reading all these posts about hitting things hard it's perplexing. I was PSA 31 at time of diagnosis, 3 bone Mets, stage M1, Gleason 9, a 5 month doubling time, a few slightly enlarged lymph nodes. I was 59 at diagnosis now age 65. There are a lot of side effects most have been treated. The usual, loss of labido, hot flashes, forgetfulness, weight gain, muscle shrinkage, and gynacomastia. It's a conundrum because others in here have had so many therapies. It makes me feel I'm not doing enough. The results are good according to the NIH people. I wonder what you and others make of this. Would you hang in there?

I was thinking that, since prostatectomy is performed with curative intent, might a 6 month delay have a negative effect on the odds for success?

I came across a French study this week that "showed that after a 3 months delay, the risk of BCR {biochemical recurrence} was significantly higher for localized prostate cancer. It seemed possible to extend this period for low-risk patients, whereas it seemed necessary to keep it for intermediate-risks and to reduce it to 2 months for high-risks." [1]

But that study had no adjuvant component.

"Lupron + abiraterone acetate + apalutamide" will hit it hard, of course, but will that also eliminate the possibility of metastasis during the waiting period?



Tall_Allen in reply to pjoshea13

"but will that also eliminate the possibility of metastasis during the waiting period?" Of course! That is the whole point of it. The citation you gave has absolutely no bearing on this case.

I am a participant in the clinical trial above. It reads close to the one you are considering. I can only speak for myself, yet can say I am happy I chose this path.

In Feb, I was diagnosed Gleason 9 in multiple cores. My CT & Bone scans were clean so I was diagnosed non-metastatic. My urologist/surgeon knew of and recommended this trial above. He referred me to the oncologist. The first 84 weeks (~3 months) of the trial involved consuming a mix of new and existing ADT. Not for the weak (there were side-effects), but it did lower my PSA from 9.1 to 0.05 (pre-surgery). When ADT finished, I had my RP surgery. Surgery went good! I am now ~3 weeks post-surgery and healing.

A little over a week after surgery, I had a consult with my surgeon. We went over my pathology report. The prostate along with 24 lymph nodes were removed. He was able to perform some nerve sparing. The organ and tissue specimens were collected for clinical trial research. I was also asked and approved UW Research to take specimens, as I'm all for science and research.

This Friday, I meet with the clinical trial oncologist. We will discuss the trial and my results. I am hoping to gleam information from him (a prognosis?) when looking at my pathology results. From this point on I'm under standard-care. The trial stays with me only to record PSA and follow-on care for the couple years.

MrkP, I wish you best going forward.


Thanks for the response. I hope your recovery is going well, and I hope for a good prognosis. What did the pathology report show?

You wrote that your scans were clear, but this trial appears to be for people where the PCa had spread: "This phase II trial studies how well apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes before surgery." Why did they recommend you for this trial?

Thanks for sharing. I'm hoping for the best for you.


Do they stop the anti-androgen treatments after awhile?

Do they keep giving u anti androgen treatment?


The ADT lasts for 6 months before the radical prostatecotomy. After the RP, you are randomized again. One group undergoes observation, while another group continues with 12 month of ADT.




"What did the pathology report show?"

The report has several pages of detail, but here are highlights. Pathology rated my Pc at 'pT3a' (3 == Extraprostatic extension). When diagnosed in Feb, biopsy specimens studied rated my Pc at 'pT2d' (2 == still in gland). I think it's important to note, biopsy (and scans) do not yield an exact diagnosis. They look for presence, locality, and strength. I feel very fortunate pathology from surgical specimens showed all 24 regional lymph nodes were 'pN0' (negative margins). I am unsure however, how much clinical trial ADT played a part. This is one question I have for the oncologist on Friday.

"Why did they recommend you for this trial?"

I was diagnosed with Gleason 9 in nine of twelve cores. The PCa was plentiful in biopsy samples, with PNI found in specimens. My non-metastatic diagnosis came from scans being clear. As mentioned above, CT and Scans only look for effects from cancer (aka... enlarged lymph nodes in the body, etc.) and are not definitive. I assume this made me a prime candidate then, for this trial.

MrkP, I can report 3 months of 'my' combined ADT mix of medicines was a lot to handle. When I read of your trial it feels long. That is 6 months of combined ADT medicines 'and' having to wait to wait twice as long for surgery. (Please note that I am not a medical professional, and my statement above comes only as a participant in a different trial.)

Again, I wish you the best going forward. Good luck!! :)

MrkP in reply to tkalaf


I'm inclined to do this trial. My only concerns are the side affects of ADT. You are right that 6 months is a long time. There is a second phase of the trial where the one group is observed and another group gets 12 more months. I could be on the hook for 18 months. I'm trying to get my body in shape so that I can weather the storm.

Fingers crossed for your meeting on Friday!

tkalaf in reply to MrkP


I went back to look at my biopsy. I wish to correct what I stated earlier on Gleason scores. For 12 core sample specimens taken, their dual scores were 9, 9, 7 (right-side) and 8, 6, 9 (left-side). As you can see, my right-side was of most concern. During my RP, my surgeon (who specializes in nerve sparing) was able to spare the left-side, and ~1/3 of my right-side. I was left with some incontinence, for which I'm learning to deal with.

When I discussed my path-report with my surgeon, there was one section he said he typically does not see in path-reports. I presume then it had to do with the clinical trial. I've high-lighted this section to discuss with my MO on Friday. Here is a partial extract:

// snip

Comment about about tumor volume:

Residual tumor cellularity is approximately 10%. There are multiple sections with apparent tumor bed but without residual viable tumor cells (significant treatment response).

// end

In my trial, there is no ADT after the RP. With the good path-report after RP, I'm hoping I'm cancer free. Of course, there is no way to be sure. So like many others, it's a waiting game for me.

If you decide on this trial, don't under-estimate the value of exercise. It will help you, especially at times when you experience (as others have termed) 'emotional-liability'.

I have an elliptical trainer at home. Combined with music, singing (near screaming), and hand-weights after the cardio, I was able to work through emotional outbursts.

The trial will track health. Specially, they check liver and kidney. They also check blood pressure. At one point, mine measured high. I was told to hold Zytega (as high BP is a side-effect). They prescribed BP medicines and once it lowered, the Zytega was resumed. I continued taking BP medicines throughout the ADT portion of the trial.

Now I was on hold of Zytega for several days, but will not forget the powerful emotions experienced the day I started taking it again. As you take ADT, you build up a steady-state endurance managing your emotions. When I had to stop, then restart again... yikes! It was a roller-coaster I'll never forget. Have support (family/friends) nearby, and take it day-by-day, you'll do fine. Wishing you best of care and heath!!

I am proponent of clinical trials. I entered a six month chemotherapy-hormone therapy trial in 2004 and have not looked back. I am still being followed. Good luck.

Gourd Dancer

Where is your trial?

It's closed. Not sure why. I know that the MO continued as standard practice and treated well over 500. However, he is not in clinic now due to health issues. When I talked to him several months ago, he was concentrating on Research, Professor duties, Family, and Health. I go back in mid-July and might get a better understanding.

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