investor.lantheus.com/news-...
This will make it more widely available than the Ga68-PSMA-11 PET scan. Johns Hopkins, where it was developed is offering it. It's approved for both high risk and recurrent/advanced. Medicare and insurance will probably cover it shortly. I know several top institutions are already giving it.
There will be other more sensitive PSMA radioindicators (like F18-PSMA-1007) but none are good at very low PSA or very small metastases.
Is Ga68-PSMA still the best?
Pylarify is more sensitive.
What is the lowest PSA that it will be effective .
I wouldn't expect much for PSA lower than 0.5 unless PSADT is rapid.
2.0 is the gold standard.
Less than that, you risk a false negative.
A false negative is not a big issue if you plan to take it again as your PSA escalates.
But if you want to do one and done, it is.
I think the numbers may be different for surgery recurrence vs radiation recurrence. Is that right, TA?
The numbers are only for surgery recurrence. Biochemical recurrence after radiation must be at least 2.0
Is there anything for PSA of 0.05? Is there any reason to have scans until PSA goes up.
No, there is nothing that will detect anything at such low PSA. Treatment decisions have to be made without imaging, otherwise, it will be a self-fulfilling prophecy.
This is wonderful news. Hopefully we can move prostate cancer treatment away from a Ready, Shoot, Aim approach. Which patients should be screened? Should all GL7 be considered? Or should it be Gleason score plus PSA? My GA68 scan lit up my seminal vesical at a PSA of . 3
There are many more treatment decisons than just where to aim.I think that unfavorable intermediate risk and high risk should get it instead of a bone scan/CT.
Sadly CT are first go round and after mine I feel they're worthless. Elevated PSA or positive biopsy should go straight to this. Only thing CT did was show MRI was needed. And if this can show extent of spread at onset all the better to plan treatment.
My comment is that way too many men are being treated based on the assumption that their disease is contained within the prostate. Awareness of the extent of disease can only improve care. As the data from various PSMA PET become available, we may need to revisit studies that lacked data that accurately defines the extent of initial disease. This could improve the outcome for focal treatment if we confirm that the disease is truly focal.
PET/CT has poorer image quality than a 3T MRI. Even MRIs are not very good at finding focal EPE or the actual size of cancer foci within the prostate. Because localized PC is 90% multifocal, imaging will never be good enough to enable effective focal treatment within the prostate.
I agree that for unfavorable risk patients, a PET/CT may replace a bone scan/CT.
Tall...Im wondering if i should hold off on my starting SBRT to get this scan to obtain a more accurate reading of my PC. It looks like i would qualify based on my recent spike in PSA to 19.3 from 10.6 a year ago. My recent clean bone scan, plus my 2-6-21 3T MP MRI makes me feel fairly confident that my cancer is still confined to the prostate,but wouldnt this newly available scan tie that down much better? Im still hesitant about any treatment because of my age. Problem is that Medicare probably wont cover it this year....not sure my waiting would be smart.
This information is quite useful. The MRI can offer clues inside the prostate, but PET/CT will be a far superior method to look for disease outside the gland. It may we'll be worth paying out of pocket if needed. You may be able to find a study on clinicaltrials.Gov that looks at other PSMA tracers.
It is an absolutely terrible idea to wait. It's a self-fulfilling prophecy. By waiting, you are allowing the cancer to grow and spread. So yes, it will show up on scans, but you will have made your cancer harder to treat by waiting.
The only reason to have a scan for you would be to find any distant metastases. But if there are, you would still debulk your prostate with SBRT, so it would not change your treatment decision.
Tall....I know you are right. I hope my RO can better explain why my PSA jumped so much so suddenly when the results of my recent 2-6-21 MRI dont show much change from the 7-6-19 fusion targeted biopsy other than the size of my prostate increasing from 42cc to 60cc. He will be looking at my past scans discs when i meet with him.
Thanks for keeping me realistic!
DCF-PYL is the same as "Pylarify" (piflufolastat F 18 Injection)
Correct?
Yes, they renamed it for marketing.
Thanks for your dedication- I feel like someone is looking out for us. Such comfort is rare . Thanks 🙏
I just read your Analysis of the various scans. I’m still a little confused. The top three were
F18-PSMA-1007
F18-rhPSMA-7
F18-DCFPyL
Which of these three is the one offered at UCLA and which one is the one offered at UCSF? Thanks TA
None of those. Both UCLA and UCSF offer Ga68-PSMA-11. They will also offer DCFPyL as soon as they make the arrangements for it.
In your opinion where does the Ga68-PSMA-11 At UCLA rank with the other imaging options you list as far as finding metastasis the earliest and at the lowest PSA level?
It says: "The winner (so far) is..."
HelloYesterday i was in the university of nuclear medecine in uppsala sweden to make psma pet ,they said to me we have problems with the intrument ,i went home again and they will send another appointment , ohhhhhhh
Better is such a difficult value to appreciate.
PYL (DCF) was more sensitive, largely because they used "more" tracer and allowed a longer "dwell time" iirc... But these were exclusions in consideration, and noted, in the study (below) as to the differences when attempting head to head G68-PSMA comparatives. Also noted is no direct comparison then head to head, with the same amounts of tracer/time. Same was shown in the F18-PSMA-1007 studies. Can't find much info on the F18-rhPSMA-7 contrast agent.
So there are differences...
Biggest benefit of the new contrasting agent(s) is increased availability and it's half-life is extended as compared to G68-PSMA as noted... Absolutely a great benefit especially to those not near Major Cancer Centers! Not to be easily dismissed.
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Quote from the one study:
doi.org/10.1007/s11307-015-...
Radiolabeling with Ga-68 is an excellent alternative for imaging centers with expertise in handling the commercially available 68Ge/68Ga radionuclide generator but without own (cost-intense) cyclotron. However, a single preparation (0.3–0.6 GBq Ga-68) may only allow scanning up to two to four patients and the output depends on the half-life of the generator. As now established at our center, a single radiolabeling procedure of [18F]DCFPyL resulted in a batch containing 6 to 7 GBq of [18F]DCFPyL. This rendered it possible to examine six patients after a single preparation with an optimal dose, which represents an advantage for centers with an own cyclotron and a production of F-18 in the daily management. Furthermore, due to the longer half-life of F-18 (110 vs. 68 min for Ga-68), it may also allow transportation to remote sites from commercial vendors.
A limitation of the current study is the lack of a consistent histological validation of [18F]DCFPyL findings. In principle, it cannot be excluded that additional lesions detected with [18F]DCFPyL may represent false-positive findings. However, particularly small PSMA-positive findings cannot be easily confirmed histologically and it is impossible to assess all lesions in patients with multiple metastases. Generally, good correspondence between [18F]DCFPyL and [68Ga]Ga-PSMA-HBED-CC findings was observed, several lesions were confirmed histopathologically, and the additional bone lesions detected with [18F]DCFPyL were verified retrospectively by CT findings suspicious for bone metastases. Thus, we believe that the high sensitivity of [18F]DCFPyL, as indicated in the current study, appears plausible. Nevertheless, the findings of the current study are to be considered preliminary and the clinical performance of [18F]DCFPyL will have to be further analyzed in the future.
Another limitation can be found in the selection of patients. We did not recruit patients for both imaging series prospectively, and the selected population cannot serve as a representative sample. Due to the selection of patients with complex clinical questions (several of them being negative in [68Ga]Ga-PSMA-HBED-CC PET/CT), it might be possible that the diagnostic accuracy of [68Ga]Ga-PSMA-HBED-CC PET/CT is underestimated.
Comparison of the two tracers has not been carried out under identical conditions, i.e., mean injected dose and start of acquisition have been higher respectively later for [18F]DCFPyL, as compared to [68Ga]Ga-PSMA-HBED-CC PET/CT. It cannot be excluded that the performance of [68Ga]Ga-PSMA-HBED-CC PET/CT would have been more similar to [18F]DCFPyL under more identical examination conditions. However, it was the aim of this study to compare the two tracers under the circumstances usually available in clinical application. Generally, lower doses and earlier acquisition periods p.i. are selected for 68Ga-labeled tracers. The time period of 1 h between injection of [68Ga]Ga-PSMA-HBED-CC and the start of PET/CT was reported by many publications [2–5].
It was beyond the scope of an observational study to show time-activity curves. The time period of 2 h between the injection of [18F]DCFPyL and the start of data acquisition was chosen in the light of conventional receptor imaging in nuclear medicine using other tracers with contrast enhancement on delayed images and is in accord with the data including time-activity curves published by Szabo and colleagues [14]. Szabo et al. have performed PET imaging at five different time points and demonstrated a small number of lesions which became visible only on PET-5 131–167 min p.i. The authors recommended delayed imaging at 2 h [14]. We have not tested different time periods between the injection of [18F]DCFPyL and the start of data acquisition.
Independently from the radiolabeling with [18F] or [68Ga], previous cancer therapies and low PSMA expression caused by tumor heterogeneity [16, 17] might be responsible for false-negative PET/CT results in some patients. We have learned from other studies that imaging of the choline transport and phosphorylation may detect PSMA-negative metastases in some cases [2, 3]. Future studies should investigate the diagnostic accuracy of F-18- or Ga-68-labeled PSMA in the early PSA-relapse <1 ng/ml, when [11C] or [18F] choline have low detection rates [18, 19] and should redefine the therapeutic impact of PET/CT [20–22]. Improved diagnostic accuracy should be confirmed by systematic comparison of sensitivity and specificity of both agents.
Conclusion
Our results indicate that the [18F]-labeled compound [18F]DCFPyL is a highly promising alternative to [68Ga]Ga-PSMA-HBED-CC for PSMA-PET/CT imaging in relapsed prostate cancer. Based on significantly higher SUV values in the PSMA-avid lesions, [18F]DCFPyL PET/CT may represent a valuable tool to detect small prostate cancer lesions with high sensitivity.
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It's all good, as long as we look at things for what they are, not what we want them to be. It is not "better" in scanning per say, but better because it will make the sensitive scans more available to patients and therefore hopefully provide better diagnostics and subsequent care!
Or have I missed something? Is funny and because all these new contrasting agents are compared to the gold standard which only just received approval at two locations (G68-PSMA-PET)... So if they're comparing themselves to the G68, there's a reason. I definitely wanted the F18 scan when I was persistent (PSA) but all my searching, and in conversation with my MO, kept leading me back to G68-PSMA scanning as the best. That was as recent as just last year. And of course I will allow for the progression to "better" but it has to be better, and not just an alternative. In that case I'll still want the "best" and one that all others are compared to.
Just thoughts...
Thanks for reading 
My article has links.
The introduction of 18 F pyl is a game changing development for men with prostate cancer. I was able to get 2 pyl scans in clinical trials over the past 5 years. My PCa had reached lymph nodes in my mediastinum which is a very sensitive area to either radiate or perform surgery on. Looking forward to joining a clinical trial for Lu177 when it is available. The real benefit will be for men who have recently been diagnosed since the scan is full body and will provide direction for initial treatment where it can identify the location(s)of the cancer. Hope it becomes available to all levels of PCa soon. The cost for the pyl will probably be less than the aggregate costs for all the other less sensitive scans and be more informative. Great news for all of us.
I think it will be quite expensive. Pyl is proprietary, whereas Ga-68-PSMA-11 was donated as patent-free. But Ga-68 requires an expensive Ge-68/Ga-68 in-house generator. So, we'll have to see how Lantheus prices it. I would like it to be cheap enough to replace the bone scan/CT as a screener for unfavorable-risk patients.
I agree that cost is a big factor, if Medicare approves the scan it may keep costs in line. We may look toward how the Axumin scan was priced for some guidance. It may also replace the T3 mri at some point. My belief is that the probable improvement in decision making by men & their doctors will spare men from useless treatments which will also have both medical and emotional costs.
Is this avalaible in Europe?
Yes. I know they have several ligands under development in Heidelberg.
Will approval of Pylarify slow the expansion and availability of F18-PSMA? I understand that this new tracer has an advantage as it can be made widely available sooner, but how does it compare as a diagnostic tool going head to head with F-18? I'm wondering why I never heard about this Pylarify? Was it not being made available outside of the clinical trials?
Pylarify is an F18-PSMA. It is the radioindicator formerly known as as DCFPyL.
So, the same as what UCSF and UCLA were using? Why a different approval process?
No. UCLA and UCSF were approved to use Ga68-PSMA-11 - a different radioindicator that also shows prostate cancers that express PSMA. I expect UCLA and UCSF will also get Pylarify.
Is there a relevant difference in the radiation dose between DCF-PYL and Ga68? Would this be a consideration in choosing one over the other? Thanks!
No, it is about the same and only a very minor consideration. Pylarify is more sensitive at lower PSA - that is the only important consideration. But an experienced radiologist should be given weight too.
PSMA Scan to be approved in USA by FDA at end of 2020?
Medicare did not pay for the Pylarify used in PSMA PET/CT Scan
Any benefits from a Choline C-11 Scan in addition to Pylarify PSMA PET MRI?If insurance denies PSMA PET coverage for an approved use, appeal!PSMA to possibly be FDA approved in Dec., according to doc at UCLA
