The PEACE programs, which is the Prostate Cancer Consortium in Europe, started already years ago with the results of PEACE-1 trials, that shows how three drugs are better than two in the settings, in the novel metastatic or monosensitive prostate cancers, associating ADT plus docetaxels plus RP. Starting from that, from the PEACE-1s, we are now shift to the PEACE-6 programs. So, the PEACE-6 program is characterized by four phase-three randomized clinical trials, three of that promoted by GETUG Unicancer in France, but of course are European multicenter trials. The first one, and I will say the goal of this program is really trying to search for the best strategies in metastatics or monosensitive prostate cancer. The first one is abiraterone-prednisone, and the standard of care is based on PEACE-1 trials in most cases. In the abiraterone-prednisone trials, the control arm, the experimental arm is characterized by standard of care plus radiotherapy, and these focus on oligometastatic patients. This trial is close to conclusion now, and we are waiting for final results.
The second is UNFIT trials that focus on vulnerable patients. In this case, the standard of care is ADT, but the experimental arm is the associations of standard of care plus the darolutamide. These trials are dedicated to patients that cannot receive RP or chemotherapy. The third one is the good responder trials, this being the patients that received standard of care treatments achieved a very good response after six to eight months. In this case, the experimental arm is to test intermittent ADT versus continuous ADT in this patient. The first trial is what I would like to present more in detail today, so I will not have results because it just started, but just to show you the design and in which I'm personally, directly involved, that is coordinated by Karim Fizazi. These trials include radioligand therapy and lutetium PSMA-617 therapy. Again, the setting is the novel metastatic, hormonosensitive prostate cancer, but they are defined as poor responders. These mean patients that do not still have detectable PSA after six to six months of therapy with a PSA level superior to or equal to 0.2.
These patients will be randomized in continuous standard of care treatment and/or in the experimental arm that is based by standard of care, plus four cycles of lutetium PSMA-617. 100 centers in Europe are expected, 7 countries, and 500 patients for inclusion. So, the primary and the secondary on point are quite standard — overall survival, radiographic PFS, and I underline based on PCWG3 criteria. We'll come back later on this point, and of course, we'll evaluate also toxicity PSA response, and other quite standards, as I said, objectives. But I would like to underline some points on the inclusion criteria, because we discussed, among oncologists and nuclear medicine physicians, we are dealing with patients with really low PSA level. Of course, all the patient will undergo PSMA PETs for randomizations, and the PET will be considered positive according to PROMISE 2.0 criteria, but we open also the possibility to include patients that have detectable PSA, but negative PSMA PET, trying to understand if we can use lutetium PSMA also in patient with residual but not visible TCs. Again, the PSA, as I said, 0.2, but need to be stable or declining, so progressive patients are not eligible. The trial started last year, so this is the randomization rate. We are now included 40 patients, and we are growing the randomizations, and the trial is expected to finish in 2029.
So actually, it is open in France. We have 20 activated trial centers, sorry. And now, I think, in June, we will open the trial to Europe, so we think that, of course, the randomizations of this patient and inclusions will increase. But if you say, "Okay. The story is finished," it's not finished, because when we designed these trials in the beginning, as you see, there is quite a standard patient inclusion with, of course, PSMA PET randomizations, but then the response is expected to be evaluated by bone scan and CT scan. So, in GETUG, now we have an expert group of nuclear medicine, as well as medical physicists that are involved in the design of all the trials that comes from the GETUG group. And so, the last year, really happy to be obtained findings for the ancillary study to the main phase-three trials, which is called IM-DOS PEACE-6 PR responder studies. In this ancillary study, we will try to include further PSMA PET images analysis during response, as well as dosimetry ancillary studies in the patient, of course, randomized in the experimental arms with lutetium PSMA.
The idea is, of course, we are talking a lot about many of, I mean, criteria to be used to evaluate a response to treatment, and the idea was to evaluate, of course, the tumor volumes and the variation of tumor volume during treatment. The primary endpoint will be to evaluate, of course, the prognostic value of tumor volume, because as I said, we'll show you some cases after of the first patient. We have some patients that have higher volume, lower volume of disease, but a patient with really low PSA volume. Then, we will evaluate the variation of the volume after cycle two, because the idea that at the beginning, the trial was designed with four lutetium PSMA cycles, but the question is, are these four cycles necessary or we need to, I will say, optimize or personalize a little bit more? So, these are two initiative cases, two preliminary cases of patients that have been treated. You see that there are two different kinds of disease, so patient with low PSA level, one on the left two nanograms, and the other one, 0.4. But you see that after two cycles, the patient achieves already partial response in one case.
It's a very good response that I will consider almost as complete because achieve a PSA of 0.02 nanograms. Of course, we have on the left patients with more disease, higher volume disease, and on the right, patient, really that can be considered oligometastatic in his residual disease. Then, so the idea to, maybe in the future, is optimize and try to understand how many cycles on the basis of tumor volumes and interim evaluation of response could be another point. Then, of course, we are using the radiotherapy in the very early phase, so it's very important to try to understand if you are toxic or not, and so this is a huge work made by the medical physicist of J2, because now we have a standardized protocol for clinical trials dosimetry. So, these documents could be used in all the centers by now in France, but of course can be exported also to Europe, and so we will start very soon with the dosimetry. We are calibrating all the centers and activated all the centers for the dosimetry ancillary studies as well.
So, in conclusions, I think that PCs in the setting of the mono-sensitive prostate cancer, so also with other trials, we'll give further information about the good strategies in these kind of patients. I think, also, that with the ancillary study, we will have other answers, I will say, to how optimize our best treatment in this patient. Thank you very much for your attention.