Establishing a theranostics center and preparing for expanding indications

Q: What exactly is theranostics, and how is it used today? 

Dr. Lowentritt: Theranostics pairs diagnostics with therapy to locate and treat disease, such as cancer, with targeted radiation. PET/CT scans identify cancer sites in the body via galliumand fluorine-based tracers, and radiopharmaceuticals, such as lutetium-177, deliver therapeutic radiation to those areas. It’s a more precise and potentially less toxic way to treat cancer – and it offers personalized care for conditions like advanced prostate cancer and neuroendocrine tumors.

Q: You’ve helped establish five theranostics centers. Do the imaging and therapy components always have to be under one roof?

Dr. Lowentritt: There are two distinct components: diagnostics (PET imaging) and therapeutic radiopharmaceutical infusion. They don’t have to be housed under one roof – and in some states regulations prevent community practices from doing both components.

Regulations vary widely. In Maryland, where I am based, we cannot provide both in the same facility, so patients receive PET scans offsite while we administer therapy in our office. Virginia has a narrow and highly regulated process for opening an imaging site, while therapy is less restricted.  Understanding the regulatory landscape is essential before deciding whether to build, partner, or take a hybrid approach. 

Q: What does it take to start a theranostics program, and what are the staffing considerations?

Dr. Lowentritt: The equipment investment for the treament side is modest – typically $15,000-$30,000 to administer Lutetium-177 therapy. The greater challenge is compliance and facility planning. 

You need a hot lab that meets requirements for storage, preparation, and waste handling. Each state will have regulations around the therapy room’s locaton, proximity to a bathroom, patient flow, isolation from common areas, and contingencies like spill management. A spill is rare, but if it happens, that space could be closed off for weeks – so thoughtful space planning is critical.

The biggest hurdle is obtaining a Radioactive Materials (RAM) license. You must specify the isotope – Lutetium-177 in most cases – along with the maximum volume you intend to store. The licensing process can take four to six months or longer, often requiring detailed floor plans. If you plan to perform both diagnostics and therapy from the same hot lab, the requirements expand further, especially if you’re going to be handling agents like gallium or fluorine. 

The imaging side also has its own full set of requirements around technology, radiology accreditation, and is a much larger capital expense. One of the questions to ask at the outset is are you going to do this yourself or engage with a third party? 

Finally, practices must staff appropriately for both therapy and imaging. Only physicians with specific levels of training, typically radiation oncologists or nuclear medicine radiologists, can administer therapy, so you will need to assemble a specialized team. Urologists and medical oncologists cannot provide these treatments without additional training. PET imaging requires a nuclear medicine technician on site and a nuclear medicine physician to interpret scans. 

It’s important to remember that theranostics is not a standalone service – you still must support the broader cancer program that the patient needs as well. This includes labs, blood count monitoring, and side-effect management.

Q: What administrative or reimbursement challenges should practices expect?

Dr. Lowentritt: The prior authorization process is very similar to what it would be with any other high-cost Part B drug, but the reimbursement varies significantly by state and payer. Payment isn’t always aligned with the traditional ASP+ model that practices are used to with chemotherapeutics and other infusions and injections. Some states also operate as “invoice-only,” which can put practices under water without careful financial modeling. 

Ultimately, insurance issues can create challenges – patient responsibility may be substantial, and some payers may initially reimburse below cost. We’ve built financial navigation and patient-assistance resources into our practice and are also able to coordinate care through a hospital partner when required by insurance.

Q: How many patients can a practice expect to treat – and how might that change? 

Dr. Lowentritt: Current indications for these therapies are for later-stage disease, meaning patients must have failed prior therapies. As of now, we are treating up to twenty patients per month with radiopharmaceutical therapy. We do, however, expect that to change with new indications that will allow upfront treatment for newly diagnosed metastatic, castrate-sensitive prostate cancer patients. This change could make about ten percent of newly diagnosed cases eligible. Earlier intervention for these patients has typically yielded better outcomes and survival rates, so we do expect volumes to increase significantly. 

Q: Do you expect more practices to explore theranostics? 

Dr. Lowentritt: Yes, I do. Most academic centers already offer these therapies, and we’re seeing oncology and urology groups express strong interest. Several community urology and oncology sites have implemented programs, with more in development. As indications expand across tumor types – including promising work in breast cancer – theranostics will continue to grow.

Looking ahead 

As indications expand and patient volumes grow, theranostics is poised to become a central component of cancer care. With thoughtful planning, the right clinical partnerships, and a clear understanding of regulatory and operational requirements, practices can position themselves to offer these advanced therapies safely and effectively. 

Dr. Benjamin Lowentritt serves as Medical Director, Cencora Specialty GPOs, and for the Prostate Cancer Program at Chesapeake Urology as well as Senior Vice President, Practice Development for United Urology Group.

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