Clinical Trial Trials

[COG1]

My husband is participating in the EMBARK Study at Winship Cancer in Atlanta (Emory). We aren't allowed to know his PSA as part of the study. The object is to determine if earlier use of Enzalutamide (hormone sensitive, non-metastatic) will cause a delay in radiographic progression. So far, his scans have not shown any bone or visceral metastasis. June of last year, his meds were stopped because his PSA was undetectable. In February, he was restarted on Meds because his PSA was, once again, rising. He has scans every 6 months as part of the study. I admit I usually just skim the report and don't read the opening paragraphs because, they're always the same...until they're not. I was looking over his report from February, 2019 and saw the following at the top "CLINICAL INDICATION: Prostate cancer status post radical prostatectomy,

radiotherapy and LHRH therapy. Now with increasing PSA." This prompted me to start looking back over previous reports. This same paragraph is at the top of his August 2018 scan report, but is not on any report prior to that. This has me concerned. I've got a call in to his Doctor, but I'm not sure he even knows whether his PSA is rising. My concern is that if his PSA is rising while on Lupron and Enzalutamide/Placebo, that he may be becoming castrate resistant. Thought?

[Tall_Allen]

Yes, that's what it means, by definition. He had to become castration resistant at some point, but the hope is that the medicine he is taking will delay the onset of detectable metastases and improve survival.

[COG1 in reply to Tall_Allen]

Thank you Allen. I was just surprised that in a double blind study where neither we nor the doctor know the PSA number that radiology would be privy to that information. Randy has been on some form of ADT since January of 2015, with a couple of very short breaks, so we are aware that there is a limit to how long it will work. I guess my concern is that if he's on the placebo and Lupron is no longer working, shouldn't we be moving on to something else? Is waiting for radiographic progression the smartest thing? The 'not knowing' is scary stuff.

[Tall_Allen in reply to COG1]

They usually want to see some sign of radiographic progression before they move onto the next therapy. Along with Erleada, the other approved medicine for non-metastatic castration-resistant PC is Xtandi - which he may already be getting. They started the trial before Erleada or Xtandi was available for this indication. The other thing to consider is that Erleada and Xtandi (and the soon to be approved darolutamide) have only proved (so far) that they delay metastases (which is the purpose of the clinical trial), and not that they increase survival (which we hope they do). I think you are right to want to discuss all this with the trial administrator.

[COG1]

So I spoke to the PA from our doctor's office. She said the notation about rising PSA was picked up from when the trial was started, and had nothing to do with Randy's current situation. She assured me that neither she, nor the doctor, nor the radiologist has any idea what his PSA might be. The only folks with that knowledge would be the trial sponsor. She 'round about' suggested that if we were worried about it, me might go elsewhere and get a PSA test. Randy wants to continue with the trial. My thoughts are that if we continue with the trial, we should adhere to the rules of the trial.