I have been trying to determine if it possible to get a 68 Ga-PSMA-11 scan done here in the USA now outside of a clinical trial. The superior sensitivity over 18 F fluclovine scans (Axumin) seems well documented now. Yet Illumet, the company that makes the PSMA-11 "kit" indicates it is only available for "investigative new drug" applications. In other words no FDA approval for it to be offered even for private pay on a doctor's order.
I want to get the scan to see if it would be favorable for me to go to Australia for 177 Lu-PSMA-617 treatment. Oligometastatic disease with lymph nodes only or at most 1 or 2 bone mets seems to be most favorable. But absent the scan here, I will have to go abroad for the assessment as well as for the treatment. Anyone with information on this?
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MateoBeach
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UCLA offers the Ga 68 PSMA PET/CT to patients with increasing PSA after initial therapy. Minimal PSA is 0.2. They charge around $ 2800. You could try this number:
I would like to know as well, we were told that it was not possible to get one without meeting study inclusion criteria by UCLA and UCSF, even if paying out of pocket.
Yes at ucla. They read it and at first said my cancer was back in my prostate. A week later they said they’d made a mistake and no cancer. Really. That happened.
Henukit, are you saying that in order to qualify for the PSMA clinical trial one has to have gone through either RP or RT? Does that limitation also applies to those that pay cash?
Yes. It's paid by patient but it's clinical trial only. For the last couple of weeks I was trying to get PSMA scan scheduled, they requested a lot of paperwork and it took them a week to respond that I'm not qualified. What a waste. Why didn't tell from the start.
Outside the USA there are many places in Europe, Australia, South Africa, India, Turkey, Israel etc. It all depends on where you will be able or willing to travel.
That is incorrect that it's "well documented." That's why it is in clinical trials, and the FDA will probably approve it based on those. For PSAs over 2, Axumin seems to be just as good. But that is not really the issue for you. The issue is that your cancer has to be sufficiently PSMA-avid for a PSMA-based treatment to be effective for you.
There are several ongoing clinical trials of PSMA scans for recurrent men like this one:
Thank you. Yes that is exactly the question: PSMA avidity as you say. Axumin won't determine that. And my PSA is currently 0.25 where there is substantial difference in sensitivity in the results that I have seen. (admittedly not a comprehensive review)
IN 10/05/2012 I had a prostectomy(DA VINCHI). I HAD A gleason 4+3=7/10. MY PSA WAS UNDETECTABLE <0.1ng/ml. bETWEEN 2012 TO 2014. IN 2015 MY PSA start going up WAS 2.4ng/ml and start taking Lupron shot(45mg) every 6-months until today 05/01/2021. I am being prescribed different hormones blocker medications(Lupron, enzalutamide, Zytiga/Prednisone, Provenge, Cabazitaxel, Lymparza. Between 11/19/19-02/25/20 received (4) Quimio Infusion. Between 04/3/20-10/08/2020 received (6)Radium 223 Injection. ON FEBRUARY 22 TO APRIL 22, 2021 Star new clinical trial new medication(SM08502-ONC-01) SAMUMED, LLC, GOT NEW PELVIS/BONE/FACE SCAN (APRIL 20, 2021). ON ARIL 27 DR. GELMAN ORDERED RADIATON THERAPY FOR LOWER LEFT JAW START ON MAY 10.
As part of the Vision trial, they sent me to Scottsdale AZ to "Scottsdale Imaging" Where they are set up to do 2 of those scans per day. One at 10am and one at 3pm..The problem being the Gallium 68 agent is it's very short half life. (68 minutes) it must be created nearby and used quickly..All the T's have to be crossed and the I's dotted..Lot's of little details to be arranged..Are you eligible to get into the "Vision" trial ?
Not sure where you are located but I had one done at Weil Cornell in NYC. It was an MRI PSMA scan as opposed to a CT PSMA scan. My insurance covered the cost of the MRI, I paid the cost of the drug which as I recall was less than $2,000.
Yes but that’s not a big deal. I had a post surgery psa. They didn’t ask me anything else, I just needed to sign the consent form. I suggest you call and see what they say. The doc running the trial is tagawa as I recall but I didn’t see him, too long a wait, I saw one of their other docs, she examined me took history and I was very up front about why I was there, for the psma scan. Let me know if you have any other questions.
Thank you all for your suggestions and perspectives. I am going with UCLA for the Ga PSMA scan. And if it is favorable for Lu PSMA treatment I am planning with Dr. Nat Lenzo of GenesisCare AU/Theranostics in Australia. Less expensive and offer outpatient treatment. (And I can explore Sydney and environs.) Here is one of the several articles on the Ga PSMA scan. this from Journal of Nuclear Medicine:
68Ga-PSMA-11 PET/CT detects prostate cancer at early biochemical recurrence with superior detection rate and reader agreement when compared to 18F-Fluciclovine PET/CT in a prospective head-to-head comparative phase 3 study
Jeremie Calais, Francesco Ceci et al.
1Munich Germany
2Loyola University Medical Center Maywood IL United States
3Oslo University Hospital Oslo Norway
4Ospedale S.Orsola-Malpighi Bologna Italy
5Peter MacCalllum Cancer Institute Ripponlea VIC Australia
6Techinical University Munich Munich Germany
7Dept. of Nuclear Medicine Technical University Munich Munich Germany
8Ahmanson Translational Theranostics Division UCLA Los Angeles CA United States
9Department of Medicine Statistics Core UCLA Los Angeles CA United States
10Department of Urology UCLA Los Angeles CA United States
11University of California San Francisco San Francisco CA United States
12University of Southern California Pasadena CA United States
Abstract
Purpose: This is a prospective single-center, single-arm, head-to-head phase 3 comparative study of paired 18F-fluciclovine (FACBC) and 68Ga-PSMA-11 (PSMA) PET/CT scans for localizing prostate cancer (PCa) early biochemical recurrence (BCR) after radical prostatectomy (RP) (NCT02940262).
Methods: Fifty consecutive patients with BCR and prostate specific antigen (PSA) levels ranging from ≥0.2 to ≤2.0 ng/mL without any prior salvage therapy were included. All patients underwent FACBC and PSMA PET/CT scans within ≤15 days. PET/CT scans were each interpreted by 3 independent blinded expert readers not involved in study design and data acquisition. Region consensus interpretation (T,N,M1a,M1b,M1c) was generated based on majority rule in cases of reader disagreement (2 vs 1). PET/CT scans were considered as positive if any region was rated as positive . Detection rates per-patient and per-region served as primary study endpoint.
Results: Median time interval between the 2 scans was 6 days (range 1-15). Median PSA level at the time of imaging was 0.50 ng/ml (mean 0.63; range 0.2-2.0 ng/ml). The detection rates were significantly lower with FACBC than with PSMA PET/CT for the pelvic region (N) (8% vs 30%; p=0.003), for any extra-pelvic lesions (M) (0% vs. 16%; p=0.008) and per-patient (26% vs 56%; p=0.003). Reader agreement for PSMA PET/CT image interpretations was significantly higher than for FACBC PET/CT by patient (p=0.015) and region (p<0.001 to 0.046) based analysis.
Conclusions: In patients with BCR and low serum PSA levels after RP, PSMA PET/CT has higher detection rates and better reader agreement than FACBC PET/CT. Therefore, PSMA PET/CT should be the imaging modality of choice in patients with early BCR.
Thank you all for your suggestions. I have decided on UCLA for the Ga PSMA scan. Easy to enroll and reasonable. I'm going with Nat Lenzo MD at GenesisCare/ Theranostics AU in Australia. They are less expensive than I've heard for Germany and do outpatient Lu PSMA Tx. Very cordial. Have Skype consult next week.
Here is one (of the several) papers published on the scan from
68Ga-PSMA-11 PET/CT detects prostate cancer at early biochemical recurrence with superior detection rate and reader agreement when compared to 18F-Fluciclovine PET/CT in a prospective head-to-head comparative phase 3 study
1Munich Germany
2Loyola University Medical Center Maywood IL United States
3Oslo University Hospital Oslo Norway
4Ospedale S.Orsola-Malpighi Bologna Italy
5Peter MacCalllum Cancer Institute Ripponlea VIC Australia
6Techinical University Munich Munich Germany
7Dept. of Nuclear Medicine Technical University Munich Munich Germany
8Ahmanson Translational Theranostics Division UCLA Los Angeles CA United States
9Department of Medicine Statistics Core UCLA Los Angeles CA United States
10Department of Urology UCLA Los Angeles CA United States
11University of California San Francisco San Francisco CA United States
12University of Southern California Pasadena CA United States
Abstract
Purpose: This is a prospective single-center, single-arm, head-to-head phase 3 comparative study of paired 18F-fluciclovine (FACBC) and 68Ga-PSMA-11 (PSMA) PET/CT scans for localizing prostate cancer (PCa) early biochemical recurrence (BCR) after radical prostatectomy (RP) (NCT02940262).
Methods: Fifty consecutive patients with BCR and prostate specific antigen (PSA) levels ranging from ≥0.2 to ≤2.0 ng/mL without any prior salvage therapy were included. All patients underwent FACBC and PSMA PET/CT scans within ≤15 days. PET/CT scans were each interpreted by 3 independent blinded expert readers not involved in study design and data acquisition. Region consensus interpretation (T,N,M1a,M1b,M1c) was generated based on majority rule in cases of reader disagreement (2 vs 1). PET/CT scans were considered as positive if any region was rated as positive . Detection rates per-patient and per-region served as primary study endpoint.
Results: Median time interval between the 2 scans was 6 days (range 1-15). Median PSA level at the time of imaging was 0.50 ng/ml (mean 0.63; range 0.2-2.0 ng/ml). The detection rates were significantly lower with FACBC than with PSMA PET/CT for the pelvic region (N) (8% vs 30%; p=0.003), for any extra-pelvic lesions (M) (0% vs. 16%; p=0.008) and per-patient (26% vs 56%; p=0.003). Reader agreement for PSMA PET/CT image interpretations was significantly higher than for FACBC PET/CT by patient (p=0.015) and region (p<0.001 to 0.046) based analysis.
Conclusions: In patients with BCR and low serum PSA levels after RP, PSMA PET/CT has higher detection rates and better reader agreement than FACBC PET/CT. Therefore, PSMA PET/CT should be the imaging modality of choice in patients with early BCR.
I'm curious as to why you feel you need to do LU-177 treatments at this time. Unless I'm missing something, you have a very low PSA, a stable remission and a low tumor burden. From what I can see, you are probaly still hormone sensitive. I can't see why you would do an experimental and expensive treatment at this point. Maybe I missed something.
There is a suggestion from Lu PSMA published results that the best response is when there is a low burden of disease (fewer mets) and that these are entirely or predominantly in lymph nodes as opposed to bone mets. So if my scan shows this to be the case, and with high Ga PSMA uptake demonstrated, then I would opt for Lu PSMA treatment early (now) rather than waiting. If it shows predominantly bony mets I would opt for 223 Radium treatment. And if it showed only one or two sites were present, I could opt for specific treatment for those sites, probably with some form of EBRT.
I am biased towards the early deployment of these modalities rather than waiting for progression and further failure of the next tier of ADT, when the disease burden and number of metastatic sites may be greater.
The question for me is: When a treatment has been shown to offer an advantage in the most advanced stages (mCRPA), is there any reason not to think that it may be even more beneficial at an earlier stage of disease? And as "a trial of one" am I willing to leave that on the table?
I will try to attach here the abstract on recently (pre) published article on Lu PSMA for predominantly lymph node disease in PC in Oncotarget. (Sent by co-author Nat Lenzo who is my consultant in Australia.
177Lu-PSMA radioligand therapy of predominant lymph node
metastatic prostate cancer
Finn Edler von Eyben1,Aviral Singh2,, Jingjing Zhang2, Karin Nipsch2, Danielle
Meyrick3, Nat Lenzo3,4, Kalevi Kairemo5, Timo Joensuu5, Irene Virgolini6, Cigdem
Soydal7, Harshad R. Kulkarni2, and Richard Paul Baum2,
ABSTRACT:
177Lu-PSMA radioligand therapy (LuPRLT) is mainly used for patients with
metastatic castration-resistant prostate cancer who are resistant to established
drugs. This study describes LuPRLT, either LuPSMA I&T or LuPSMA RLT-617, for 45
patients with predominant lymph node metastatic prostate cancer (LNM PC). Thirtyfive
patients had LNM and ten patients had LNM and one or two bone metastases.
Before LuPRLT, the patients had prostate specific antigen (PSA) of median 18 μg/l
(interquartile range (IQR): 3.3–39). LuPRLT was given with a cumulative injected
177Lu activity of median 14.5 GBq (IQR: 12.2–20.4). Maximum percentage decline of
PSA was median 92% (IQR: 70–99). Thirty-five patients with only LNM had a better
overall survival (OS) than ten patients with LNM and one or two bone metastases.
Thirty-three docetaxel-naïve patients had a longer PSMA PET/CT progression-free
survival than twelve patients who were resistant to docetaxel. Twenty-two patients
who received LuPRLT with a cumulative injected 177Lu activity ≥ 14.8 GBq had a
better PSMA PET/CT progression-free survival than 23 patients who received LuPRLT
with a lower cumulative injected 177Lu activity. Seventeen patients with relapse
after LuPRLT who received rechallenge LuPRLT or ActPRLT had a better OS than
five patients who received other forms for relapse treatment. LuPRLT gave mild and
transitory adverse effects. The findings of the present study suggest that LuPRLT
of patients with LNM may be effective and safe. The promising results motivate
randomized phase II trials to further quantify the impact of LuPRLT as treatment
I like you wanted to hit it hard while it was small.
Seven years ago I had a prostectomy. My highest PSA was 7.4 but had a gleason 9. My PSA began to climb slightly. It got up to 0.72, so I got a standard PET scan done in Anchorage Ak. That scan showed nothing significant. My surgeon at UCSF suggested that I should come there for a GA68 scan and I was able to arrange that about 3 months later.
Medicare paid for the PET/MRI part, but I paid for the GA68 part, which amounted to a little less than $1000.
That scan showed several (6-10) lymph node mets in my abdomen, and I was diagnosed with stage 4 MPC. I started on Casodex for 30 days, then Lupron and Zytiga, with Prednisone.
My PSA and T levels dropped below detectable levels, but I didn't like the prospect that I was being told about.
After much study, I looked for a place that would give me the LU177 treatment though I was not yet castrate resistant. I found dr. Baum at Bad Berka Germany.
I thought about Australia, because it was cheaper, but dr. Baum had so much experience, that I decided to go that way.
The cost there was about $15,000 US, plus travel. I couldn't have asked for a nicer facility, or better dr. and staff!
Despite the ADT working per the PSA and T tests, a GA68 scan there showed progression now including a bone met on a rib.
Dr. Baum is very confident that one treatment is all that I need, since my mets were still very small. He wants me to monitor my PSA every month, and report any rise to him.
I just got my test results back after 6 weeks post LU177 treatment, and still on ADT, and my PSA is <0.02, and T is <10.
If I had just relied on ADT, who knows how many bone mets I would have soon?
I'm glad I went for the early treatment with LU177
Congratulations on the good payoff for your aggressive pursuit. You are an inspiration for me and I am happy for your result. Encouraging in that only one Lu treatment needed for that.
Late to read your comments. I concur with your approach; go for it while the mets are minimal (or before). My Lu177 sessions in 2017 shrank or eliminated my soft tissue mets - see my recent post for more. You just have to put up with Aussies if you go to Australia!
It may be to late to answer you, but I had the scan done at the Indiana University School of Medicine in Indianapolis. My purpose was to forward the results to Germany in preparation for treatment with Lutetium. My initial contact in Indianapolis was Sloan at:
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Why do Bone Scans and CT Scans if PSMA-Pet are available?
68 Ga-PSMA & too much bad news
Conflicting MRI vs PSMA scans
GA-68 scan Availability in US.
