GU Oncology Now: Can you give our viewers some background on yourself?
Dr. Juliano Cerci: Well, I’m nuclear meds physician, here in Brazil. Also, did my specialization in radiology, many years ago. I’m here in Curitiba, for the last 10 years and we’ve been collaborating with the EIA, a branch from UN, and we had the chance to perform this very nice study collaborating with 17 centers from 15 different countries. We had all the support from the EIA team, including Dr. Lovato and Stefano Fanti was the leader, mentor of this project, which finally we could publish in a very nice way and I hope we can discuss this in more detail.
What prompted you to undertake this study?
As you probably know, we have a lot of publications from Europe about PSMA and now also from Australia as well, but we have very few data and solid data from developing countries, right? The idea of the study was to congregate this big, big team and see if the conditions and the accuracy of the PET imaging in this scenario of prostate cancer with Gallium PSMA has this very same accuracy and results than the studies performed in Europe, which are very developed centers, very specialized. So this was our main goal in this project. And we could have a lot of collaboration on that, in that scenario and finally, we could publish this very recently in J & M.
How was the study conducted, and what were the findings?
So the idea was to evaluate patients in biochemical relapse in a early stage of VCR. We had the inclusions criteria is that patients had to have PSA less than 4. It was allowed to have PSA between 4 and 10, but only if with MR negative and bone scintigraphy negative. And that was the main including criteria. Of course, the patients has to be, had to be submitted to, previously to radiotherapy or a radical prostatectomy. And all patients were submitted to gallium PSMA 11 as radiotracer and all the images were reviewed centrally here in Curitiba.
Did you find the results surprising?
Well, in a certain way, most of our results were in line with what we already know from these very specialized center publications. The difference is that we’ve had a huge number of patients, we have more than a thousand patients. And what we found was in a similar fashion way about the positivity rates, we found that the positivity PET imaging was correlated with the Gleason score, the higher the Gleason scores, of course, the higher the chance of the patient to present a PSMA positive scan. The PSA at the bedtime was also correlated to the positivity of the scan. The higher the PSA, the higher is the chance to have a PSMA positive. The PSA doubling time, the shorter the PSA doubling time is the higher chance to have a PSMA scan positive. And what we found that was really interesting and this is somehow new is that patients that were treated primarily with radiotherapy also had more chances to have a PSMA positive scan.
So this is the already somehow known results that we, we evaluated. What we also evaluated that was really interesting is that before the patients was submitted to pet scan, we had submitted the clinician’s questionnaire about the planning to treat these patients and after the PSMA, we submitted the same questionnaire and we found that more than 65% of the patients would have their treatment change based on their PET results. And the most important finding in my opinion is that, we had no statistically difference between countries and continents. We analyzed by this income from the countries and also by continents, and there was no difference in the results between the patients from Italy, from Europe and the patients in more developing countries.
What were some of the advantages and challenges of this study being an international collaboration?
Well, it, the advantages and the challenges that we have was, of course, to combine all these data. We had three in-person meeting and more than 1000 emails review, all the scans was not easy. So, we had to receive this data here in Curitiba. This was a big challenge. And of course we have to being in contact with all the centers to check the CRFs and this was a big challenge also, and we had no support like big companies, big pharmas to support us. So this was mainly done by ourselves. This was a great challenge, but the advantage is, of course, that we have very good number of patients in very different countries, in different centers and these things is, in my opinion, the best way to see how this high level technology works in a more day by day scenario, in different scenarios, different, different cultures and countries.
Any closing thoughts?
I just need, of course, to acknowledge everybody that really supported us on that. I could not be more thankful from EIA, from the support to bring all us together and all those countries with all those teams, it’s not only the nuclear medicine department, the PET centers that were involved, we need the involvement of urology, pathology, with the involvement of oncology. So this was a big, big effort of a lot of people and I’m really grateful for this collaboration that we could work.