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Clinical Trials for Bladder Cancer Examining Advanced Imaging, Surgical Techniques

New treatments prioritize improved diagnostics, treatments, and bladder-sparing options

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Anatomic graphic showing cancerous cells in the bladder

Duke Cancer Institute (DCI) Center for Prostate & Urologic Cancers leads with innovative trials to improve treatment options and long-term outcomes for patients with bladder cancer. The clinical trial portfolio for bladder cancer is expanding, from improved imaging and diagnostics to new surgical approaches that potentially spare the bladder. “We have a lot of exciting trials and energy around bladder cancer at DCI,” says Michael A. Abern, MD, urologic oncologist.

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Enhanced diagnostics

DCI is heading an investigator-led initiative in collaboration with Duke computer engineers to develop a super-resolution ultrasound, which creates highly detailed images of the bladder. This technology overcomes existing limitations in ultrasound by using ultrasound contrast microbubbles to create an ultra-detailed map of the bladder’s microvasculature, thereby more precisely illuminating a tumor’s blood supply. Because bladder cancer can be aggressive, the timeliness of receiving an accurate diagnosis and treatment plan is critical for patients. 

Abern explains that the bladder is a challenging organ to image because its size and shape change as it fills and empties. Using highly advanced algorithms, computing can track bubbles as they flow through the bladder in time, monitoring ‘traffic’ through the bladder. “We can see how fast and in what direction blood is flowing in the arteries and out through the veins with incredible detail, which allows us to distinguish what is cancer and what is normal in the bladder wall.”

Abern is studying the accuracy of this imaging as a first-in-human test immediately before radical cystectomy. “If this imaging achieves the improved sensitivity for residual cancer, it could result in patients becoming eligible for less radical surgery, including partial cystectomy or sparing of adjacent organs,” he explains.

Novel treatments and immunotherapies

Ankeet Shah, MD, urologic oncologist, treats bladder cancer across the spectrum, including rarer variants, such as plasmacytoid and lymphoepithelioma-like urothelial carcinoma. “We see a lot of rare cases and have the expertise to offer effective treatments for these patients. For cancers of genetic origin, we also have advanced genetic testing and counseling capabilities for patients,” Shah adds. 

One promising treatment the Duke team is studying involves immunotherapy that’s up to four times more potent than the currently available BCG (Bacillus Calmette‑Guérin), an effective intravesical immunotherapy for early-stage non-muscle-invasive bladder cancer (NMIBC).

Other clinical trials examine whether monitoring circulating tumor DNA (ctDNA) more proactively informs treatment after a radical cystectomy. Identifying ctDNA may detect a patient’s unique cancer DNA in their blood long before the cancer can be identified with standard imaging tools. This may lead to quicker intervention with immunotherapy or other systemic therapies for cancer recurrence.

Surgical innovation

“We’re on the cutting-edge of what’s possible with surgical interventions at all stages of the disease, and we want to improve cancer outcomes as well as optimize quality of life and burden of care considerations,” Shah says. 
According to Shah, while up to 80% of cases are NMIBC, “We have a lot of energy around both non-muscle-invasive and muscle-invasive bladder cancer [MIBC], which require very different approaches and modalities.” 

For transurethral bladder tumor resection procedures, a mainstay of diagnosis but also treatment for NMIBC, Shah uses blue light cystoscopy, which involves an injectable glowing dye that’s absorbed by cancer cells. When under a blue light, the cancer cells appear bright pink. “This helps us find and more effectively remove tumors compared to standard white light,” says Shah. We have various new FDA approved treatments to prevent NMIBC recurrence and facilitate bladder preservation.

For MIBC, the standard of care has been bladder removal. Shah says that there’s emerging data supporting safer methods of bladder preservation. However, when the best treatment is bladder removal, Shah utilizes fully robotic and enhanced recovery techniques as well as continent urinary reconstruction (e.g., neobladder) to get patients the best quality of life after surgery. In some cases, bladder reconstruction and more conservative bladder-sparing procedures are used with close monitoring.

Expanding outpatient services

The Center for Prostate & Urologic Cancers has also launched a new outpatient monitoring program for patients with small bladder tumors who can be monitored with surveillance. Laser ablation, an in-clinic procedure, is another unique treatment the team is now offering at the Southpoint clinic in Durham. “There’s some evidence that laser ablation can help some patients avoid surgery, which is particularly advantageous for patients with complex medical conditions or frailty,” says Abern.