RADIONUCLIDE TREATMENT OF PROSTATE CANCER IN GERMANY – Prof Dr med Stefan Dresel
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Prof. Dr. med. Stefan Dresel is an outstanding specialist in the field of nuclear medicine and one of the pioneers in Lutetium-177 PSMA therapy for men with prostate cancer. The professor personally participated in the launch of the laboratory for the production of Lutetium-177 and accumulated extensive practical experience.
Prof. Stefan Dresel began his professional career in 1992 as a research fellow in the Department of Radiology at the University Hospital of Ludwig Maximilian University of Munich. This was followed by work in several Departments of Nuclear Medicine at university hospitals and Institutes of Diagnostic Radiology, and a two-year internship in the USA. You can find the professor's full curriculum vitae here.
Now Prof. Dresel sees patients at the Helios Hospital Berlin-Buch. He has been the Head of the Department of Nuclear Medicine with its own laboratory for the production of therapeutic radionuclides for about 20 years. In the interview, the professor tells us about the treatment of advanced stages of prostate cancer using radionuclide methods and the unique capabilities of German medicine in this area.
Hello, Prof. Dresel! Thank you very much for taking the time to meet with us, give us an interview, and tell us about your work. Could you please introduce yourself?
My name is Stefan Dresel. I am the Head Physician of the Department of Nuclear Medicine. I've been working here for almost 20 years. During this time, we have managed to create an excellent department. I may have already mentioned this earlier, but I'll repeat that we opened a new inpatient clinic for radionuclide therapy in 2009, 15 years ago. There are single and double wards here, and we have created all the necessary conditions for maximum patient comfort.
Could you please tell me how many patients from abroad come to you for treatment?
The number of foreign patients depends on the innovative treatment methods we offer. Today we are going to talk about the treatment of patients with prostate cancer. Many patients with this diagnosis come to us from abroad. According to our calculations, the proportion of such patients is about 30%, and over the past year and a half, their number has only grown.
From what countries do patients come to you?
We treat patients from various countries. Many patients come from countries east of Germany, such as Russia and Poland. However, many patients from the USA also came to us until recently. Most foreign patients choose for their treatment the country where the radiopharmaceutical was approved for use earlier. When patients are well informed about the availability of treatment and medications in a particular country, they are quite willing to fly for treatment abroad to receive therapy as early as possible, rather than waiting for it to be available in their native country.
In your opinion, why do patients come to Germany for treatment, and what are the advantages of medical care in Germany compared to other European countries?
Everyone knows that the healthcare system in Germany is very well developed, and all processes in this area are well organized. In addition, the healthcare sector in Germany is well funded. These three points are of crucial importance. Hospitals in our country have state-of-the-art equipment, comfortable infrastructure, and highly qualified personnel. Our conversation today will be devoted to oncology. This area of medicine is constantly developing, so another important thing plays an important role as well, and this is the availability in the country of the latest scientific developments and innovative diagnostic and treatment methods, as well as the ability to provide all this to patients. Most hospitals in the country and, in particular, our clinic, have at their disposal all of the above resources.
In your opinion, are there any differences in the treatment of patients in Germany and other countries?
When talking about nuclear medicine, the success of the treatment largely depends on the equipment. In recent years, new combined devices have been developed, such as PET/CT and SPECT/CT, which enable imaging with maximum precision. Of course, patients need to have access to these innovations. However, the imaging device is only one of two key components in the arsenal of a nuclear medicine specialist, and the radiopharmaceutical is the second integral component. There are currently standard radiopharmaceuticals that are available all over the world, but there are also new developments in diagnosis and treatment. It is therefore necessary either to obtain permission from the state authorities to purchase such radiopharmaceuticals in other countries or to establish the production of radioisotopes in your own country.
Our department has a special chemical laboratory for the production of radioisotopes, so we have the opportunity to produce radiopharmaceuticals ourselves. The current situation in the pharmaceutical sector in Germany is quite unique, which distinguishes our country from most other states. According to paragraph 13.2b of the German pharmaceutical laws, radiopharmaceuticals are allowed to be produced personally for each patient under the supervision of a physician and to be used for therapeutic purposes, even though a particular radioisotope cannot yet be purchased commercially from a pharmaceutical company. This is one of the reasons why we can offer patients treatment with promising pharmaceuticals much earlier than many other countries can.
How does Lutetium-177 PSMA therapy work? What makes it so special?
To answer this question, a term such as "theranostics" should be mentioned. This concept combines therapy and diagnosis.
We use a certain substance, namely a small protein molecule. This is a protein molecule called PSMA, a prostate-specific membrane antigen. It is important here not to confuse the term "PSMA" with the term "PSA", a prostate-specific antigen present in the blood serum of patients with prostate cancer. We can bind the PSMA protein molecule to one of the following radioactive substances: Gallium-68 or Fluorine-18 for PET/CT imaging tests or Lutetium-177 for therapy.
The uniqueness of this approach is that PSMA is used to conduct a PET/CT scan, which can be used to obtain accurate data on the spread of cancer, the presence or absence of metastases, and, if metastases are detected, to determine which organs are affected. The PET/CT scan thus allows us to examine all organs and anatomical structures of the patient's body. Should the oncological process be confirmed, the same PSMA will be bound with Lutetium for so-called internal irradiation or radionuclide therapy aimed at destroying cancer cells, and the death of cancer cells is the goal of treating oncopathology.
Another key term in this context is "targeted therapy". This is a type of treatment that allows for the targeted destruction of a malignant tumor. Healthy adjacent tissues are practically not damaged during this treatment. And this is our objective when conducting Lutetium-177 PSMA therapy. The key to this treatment method is the fact that we use a substance that specifically binds to tumor cells and affects the tumor through a radioactive component, due to which the therapeutic effect is achieved.
When should a patient with prostate cancer pay attention to this therapy?
The answer to this question is very simple: there are clear guidelines, including international ones, and clinical protocols. These documents state that the radiopharmaceutical Lutetium is currently a commercially available product.
According to the guidelines, the first-line treatment for patients with prostate cancer is hormone therapy, namely androgen deprivation therapy (ADT). The treatment is aimed at suppressing the production of male sex hormones, androgens, which stimulate the growth of cancer cells. Hormone therapy is the standard treatment option, but as cancer progresses, the tumor in most men becomes resistant, resulting in the further growth of metastases.
Chemotherapy is carried out as a second-line treatment, for example, using Docetaxel or Cabazitaxel. This treatment usually gives a good result, but only for a limited period of time, after which the tumor growth resumes. And at this stage, according to the guidelines, the patient is indicated for Lutetium-177 PSMA therapy.
It should be noted that although prostate cancer also occurs in young men, most cases of oncology are still diagnosed in elderly patients. We admit many men with concomitant diseases, for example, severe heart diseases, lung conditions, and other pathologies. In such situations, oncologists are often faced with contraindications to chemotherapy. If the patient cannot receive chemotherapy due to concomitant diseases, Lutetium-177 PSMA therapy can be started immediately after hormone therapy. In such situations, chemotherapy is not carried out.
In any case, it is our responsibility to tell the patient about the standard treatments specified in the guidelines. The next step is individual work with a specific patient: we look for the optimal type of therapy, taking into account the stage of prostate cancer.
Prof. Dresel, do patients with stage 4 prostate cancer have a chance of recovery or at least of improvement in their health condition?
This is an important question because you should understand that Lutetium-177 PSMA therapy is an internationally recognized effective treatment method. We can therefore significantly improve the patient's condition. Since Lutetium therapy is carried out at the advanced stages of prostate cancer, the goal of this type of therapy is not only to normalize the patient's condition and prevent the progression of oncological pathology, but also to maximally suppress the entire oncological process in the body.
I started using Lutetium treatment about 6 years ago. We already know that the best treatment results can be achieved in patients with metastases in soft tissues and lymph nodes. Good results can also be achieved when patients have bone metastases. Large-scale studies are currently being conducted, the most significant of which is the VISION trial, whose results were published in 2021. This trial found that Lutetium-177 PSMA therapy can significantly prolong the patient's life, improve its quality, and, which is extremely important, especially when a patient has bone metastases, prolong the period of time before the development of bone fractures against the background of the growth of metastatic foci. This point plays a very important role in ensuring a high quality of life.
In this way, we are able to achieve good results, I would even say incredible results, in the treatment of patients who, at the time of seeking medical help from us, complain of poor health and unsatisfactory general conditions, as well as suffering from pain. After completing the course of treatment, the patients' health improves significantly: their general health condition improves, it becomes easier for patients to move, and patients no longer need to take high doses of painkillers. We constantly note such positive changes after Lutetium therapy.
It is also necessary to understand, and we have already discussed this, that patients have a medical history. With its help, the doctor can see that they have already undergone hormone therapy, many have undergone chemotherapy, and some patients have also undergone surgery or radiation therapy. Patients are well aware that further treatment options are gradually being exhausted. At this point, we begin to consider the possibility of starting PSMA therapy.
A desperate patient suddenly hears from a doctor that there is a treatment option, after which their condition will improve. This is a good prospect that gives the patient the courage to fight for life.
How long do patients remain under medical supervision during treatment?
As a rule, a hospital stay for patients is three days. Germany has a strict radiation protection law, and, as I mentioned earlier, the radioisotope is excreted through the kidneys, which means that a person excretes radioactive urine, which must be specially disposed of. Therefore, a patient who has just undergone Lutetium therapy cannot use the toilet in their own home because this poses a danger to the people who live with them. It is for this reason that a hospital stay is required.
In addition, it should be taken into account that patients undergoing radionuclide therapy are often seriously ill, so in the first days after the injection of the radioisotope, it is better for them to remain under the supervision of doctors in the hospital. So if any problems arise, we can provide the necessary medical care.
In your opinion, what is the reason for the popularity of Lutetium-177 therapy?
The situation with prostate cancer in men is similar to that with breast cancer in women. Due to the high prevalence of prostate cancer, men have access to all the information on this topic. There are also self-help groups where patients with the same diagnosis join. They help and support each other, share their experiences, and discuss what treatment methods are currently available to combat a particular type of cancer.
Lutetium-177 PSMA therapy is administered at that stage of cancer when there are practically no alternative treatments. This is one of the reasons why it gained popularity among patients. Personal experience of patients and research results confirm its effectiveness and relatively good tolerability. It is this that explains the great popularity of this type of therapy.
We must tell patients that there are other treatments available. In addition, it is necessary to tell the patient what type of treatment is the best one at a particular stage of cancer. There is no point in prescribing PSMA therapy to a patient immediately after establishing the diagnosis of prostate cancer because there is still no data confirming the effectiveness of this type of treatment in such cases. In addition, there are other effective first-line treatment options. We want to maximize the life expectancy and quality of life for prostate cancer patients, so it is critical that all possible treatment options are used before PSMA therapy, which is the last-line treatment.
How long have you been carrying out this type of treatment? Can we already talk about the effectiveness of the procedure?
We started carrying out PSMA therapy about 6 years ago. The Lutetium-177 radiopharmaceutical was developed in Heidelberg. The first data on the drug began to appear between 2014 and 2016. Thanks to the law regulating the pharmaceutical industry in Germany, we had the opportunity to be one of the first to independently produce a radioisotope. Here in Berlin, the relevant regulatory authorities control the process of producing radiopharmaceuticals, which allows the radioisotope to be used individually for each patient.
Consequently, we started our own production of the Lutetium-177 radiopharmaceutical many years ago and achieved good results in our work. We also focused on scientific publications on this topic, thanks to which we were confident that at certain stages of the oncological process, Lutetium-177 therapy is a good auxiliary treatment method or an alternative therapeutic option for the patient. This is how we began to gain experience with this type of treatment.
What is the difficulty of this type of treatment? Why is the therapy not available in other countries?
Until a radiopharmaceutical is available for free sale, it is always necessary to take into account the laws of the pharmaceutical industry in a specific country. Only this approach allows us to understand whether the production or use of the drug in the country is possible. I have already said that Germany has such an opportunity. The radioisotope Lutetium for PSMA therapy is currently approved in North America by the US Food and Drug Administration (FDA). A similar regulatory body has also approved the drug in Europe.
However, Lutetium-177 will not be available for widespread use in every country. This is due to the presence of a radioactive component in its composition, which naturally decays. The laboratory that produces Lutetium should therefore be located relatively close to the medical facility where PSMA therapy is carried out. In some situations, air transportation can be used, but not over long distances. For example, it is almost impossible to produce Lutetium-177 in Europe and use it in the USA because a large amount of the radioactive component is lost during air transportation.
It is for this reason that, for example, in North America, only a limited amount of the radiopharmaceutical is available. The situation is also similar in Asian countries. The pharmaceutical company Novartis, of course, is making every effort to expand the production of the radiopharmaceutical to make it available in larger quantities and in more locations. However, this process is time-consuming. Establishing such a production line is quite a complex process, and therefore it will certainly take some time before the radiopharmaceutical is commercially available worldwide.
Until recently, we treated patients only with radioisotopes of our own production, but after Pluvicto from Novartis was approved, we are also working with it.
Let's get back to Lutetium therapy itself. Why is it important not to miss the moment and not be late with radionuclide therapy? When is the best time to carry out treatment without harming the patient's health?
A certain period of time is needed for the treatment to work, so it is extremely important not to miss the most appropriate moment for it. Even patients who have a good response to therapy require at least two courses of treatment before a positive result can be observed, and patients can feel it on their own. Two courses of therapy are carried out at an interval of two months, after which it is necessary to wait a few more weeks until the effect of the second course of therapy appears. After this time, the patient's condition should normalize, and they will feel an improvement after the treatment.
It is known that the bone marrow may be damaged in patients with multiple bone metastases. It is quite difficult to carry out radionuclide therapy in such cases. We need to do blood tests and assess liver and kidney function. The functioning of other organs must also be satisfactory so that the patient can tolerate therapy. For example, if the red blood cell, white blood cell, and platelet counts are poor because the patient's bone marrow is not able to produce enough blood cells, we either cannot conduct the therapy at all or there are risks associated with the therapy. In such situations, radionuclide treatment may lead to even more severe damage to the bone marrow, which in turn will negatively affect the patient's condition.
These are the main reasons why patients should not hesitate to undergo PSMA therapy when they have indications for it.
And do you make a decision regarding therapy for each patient individually every time?
Yes, I do.
That is quite a challenging task! And finally, I am going to ask my last question. What advice would you give to patients who are considering Lutetium-177 therapy but have not yet made a final decision? Should they come to Germany for treatment, or should they choose treatment in their native country?
A key feature of providing medical care in the field of oncology is that a treatment regimen is elaborated at an interdisciplinary tumor board. For me personally, this plays a very important role because not a single patient receives treatment without first discussing their clinical case with our colleagues: oncologists, radiation therapists, urologists (in the case of prostate cancer), and other specialists. This approach allows doctors to study the patient's clinical case together and make the optimal treatment decision. We also study clinical cases of foreign patients during our interdisciplinary tumor boards, so even if the patient is not in our hospital, they can provide their medical reports to us, based on which we, together with our colleagues, will determine whether this type of treatment is suitable for the patient or not. I would therefore advise patients to provide us with their medical reports, after studying which we can make a decision on the advisability of PSMA therapy before coming to Germany for treatment.
An important part of PSMA therapy is a PSMA PET/CT scan. We already talked about this at the beginning of our conversation. It is always easier for us to make a decision on the advisability of radionuclide therapy when we have the results of the PSMA PET/CT scan. This diagnostic test does not necessarily have to be carried out in our clinic, so patients can undergo it in their home country and send us the scans. It is the results of PSMA PET/CT scanning that play a conclusive role in making a decision regarding PSMA therapy.
So, the first thing that is required from the patient is to provide us with the results of PSMA PET/CT scanning and blood tests, as well as a medical history that includes previous treatments. The next stage is when we study the patient's medical history at our tumor board, after which we make recommendations, for example, through a video call on Skype or Zoom. After that, we make an appointment in our clinic for the patient, examine the patient, and make the final decision on Lutetium therapy.
Would you recommend that patients come to Germany and undergo PSMA therapy here or choose treatment in their native country?
I cannot answer this question in general, as it all depends on which country the patient is going to come from. Of course, in medicine, it is always important to pay attention to those hospitals that have experience with certain therapeutic procedures. By the way, this principle applies not only to medicine. It goes without saying that if you have experience and have been performing this or that procedure for many years, the results will be good. We are also well aware of what drugs need to be prescribed before therapy to prevent side effects. Even if the patient experiences side effects, we will certainly provide the necessary medical care. Speaking of Lutetium therapy, it is also important to accurately determine the number of treatment courses or even decide to stop treatment if it does not give the desired result. Such situations also happen, and it must be a considered decision if you want to stop a course of therapy. If the treatment does not work, the patient will not get any benefit from it.
So, my advice is to look for a medical center with experience in conducting this type of radionuclide therapy and an interdisciplinary approach to treatment. It is important that the clinic has the opportunity to involve specialists from related disciplines in the therapeutic process. For example, patients with prostate cancer often have kidney problems because metastases in the lymph nodes prevent the normal removal of fluid from the body. In such cases, a consultation of a urologist is required. This is just one example of many. So, an interdisciplinary approach is a very important aspect of treating patients.
Dear Prof. Dresel, thank you very much for the interview! It was very interesting and informative!
Thank you too!
Read:
Treatment of prostate cancer in leading German hospitals: the innovative drug Lutetium-177
Lutetium 177-PSMA: a new generation drug for prostate cancer treatment