Theranostics: Clinical Promise, Operational Hurdles, and the Road Ahead

A new frontier in cancer care is quickly gaining traction, and its name—theranostics—may soon become part of everyday clinical vocabulary. In a session at the 2025 CPC+CBEx conference, expert panelists Sukumar Ethirajan, MD, founder of KanceRx, Brandon Mancini, MD, MBA, FACRO, medical director of BAMF Health, Melody Mulaik, MSHS, CRA, RCC, RCC-IR, FAHRA, FRBMA, COO of R3, were joined by moderator John E. Hennessy, MBA, BCPA, principal at Valuate Health Consultancy, to dissect the clinical, logistical, and financial realities of this rapidly advancing modality.

At its core, the panel explained that theranostics combines diagnostic imaging with targeted radiopharmaceutical therapy, enabling clinicians to visualize and treat cancer using the same molecular target. 

Mancini, whose practice at BAMF Health is among the few freestanding theranostics centers in the US, laid out a compelling vision for this evolving field. Using a vertically integrated model—with onsite radiopharmacy, advanced molecular imaging, and a dedicated treatment clinic—his team delivers therapies like Pluvicto for metastatic castration-resistant prostate cancer (mCRPC) and Lutathera for neuroendocrine tumors.

“We can scan the patient today, treat them, and by tomorrow see exactly where the radiopharmaceutical landed,” he said. This closed-loop model supports rapid adjustments and gives both patients and clinicians immediate insight into efficacy.

The expansion of theranostics beyond prostate cancer is already underway. As Mancini noted, “We’re seeing phase 1 and 1a studies across 12 solid tumors…this is no longer just a prostate story.” With new radiolabeled targets on the horizon—such as DLL3, CD46, and STEAP1—the pipeline is expanding toward lung, breast, and other tumor types.

Ethirajan offered the perspective of a medical oncologist working within a large urology practice. His practice has integrated medical and radiation oncology, giving them a head start on adopting theranostics. “We’ve treated about 30 patients in the last 6 months,” he said, citing improvements in Pluvicto availability and growing patient demand.

While early access was restricted to heavily pretreated patients post-chemotherapy, recent label expansions now allow Pluvicto in earlier lines. Ethirajan emphasized the importance of coordination: “This isn’t a handoff—it’s a team sport involving nuclear medicine, radiation oncology, medical oncology, and support staff.”

Importantly, he framed theranostics as an emerging “fifth pillar” of cancer treatment—alongside surgery, chemotherapy, radiation, and immunotherapy—and noted its potential role in sparing patients from androgen-deprivation therapy (ADT). “Almost all patients dislike ADT; quality of life improves when we can spare it,” he said.

While the clinical promise is clear, the path to adoption is riddled with logistical complexity. Melody Mulaik addressed the operational and revenue cycle challenges, emphasizing the importance of planning from day one. “Money doesn’t always follow clinical as fast as we’d like,” she cautioned.

Key areas for planning include:

• Staffing: Defining roles for physicians, APPs, and nuclear medicine specialists;
• Facilities: Radiation shielding, hot lab requirements, and imaging capabilities (PET/CT, SPECT/CT);
• Accreditation and Safety: Meeting NRC requirements, defining authorized users, and building cross-disciplinary trust;
• Reimbursement Models: Navigating disparate policies across Medicare, MACs, and commercial payers.

Mulaik also flagged the evolving payment landscape. “Expect movement toward flat-rate or episode-based payments. Plan for today’s rules but be ready for tomorrow’s models.” She encouraged practices to explore diversified revenue strategies—including cash-pay and international pathways—to hedge against reimbursement delays.

The panel emphasized the need for standardized workflows, especially in early-stage programs. Mancini noted that while many patients now arrive with good baseline health, maintaining quality of life remains a key goal. “Earlier treatment typically yields better control,” he said. “We’ve had treatment-free intervals lasting over 2 years after just a few cycles.”

From a strategic growth standpoint, centers must assess whether to begin with prostate-focused services or broader radiopharmaceutical offerings. The panel also advised using experienced architects and contractors familiar with radiation facility needs.

Importantly, panelists urged clinicians not to wait for perfection. “We’re still early,” Ethirajan said. “Every site is different; every patient is different. But the infrastructure is improving, and we can’t afford to delay.”

The session closed with a look at theranostics' future trajectory. All panelists agreed that therapies currently positioned in late-line metastatic settings will move upstream as evidence grows. Mancini mentioned ongoing trials exploring Pluvicto in combination with surgery or radiation for locally advanced disease. 

The key message from this session was clear: theranostics is no longer an experimental concept—it is an emerging standard of care that demands infrastructure, coordination, and investment. With targeted therapies, real-time imaging, and growing US Food and Drug Administration (FDA) approvals, the field is poised for expansion—but only if community and academic centers alike commit to building the necessary systems.

Reference 
Ethirajan S, Hennessy J E, Mancini B, Mulaik M. Novel therapy imperatives part 2: the rapidly changing landscape of molecular therapy, radiopharmaceuticals, theranostics. Presented at the Clinical Pathways Congress; September 5, 2025; Boston, MA.