“For decades, we have been actively developing bench-to-bedside solutions and participating in the most promising bladder cancer clinical trials. Our research infrastructure is both highly developed and nimble and includes specialized intravesical nurses and close relationships with Fox Chase pharmacists.”
Andres Correa, MD
Associate Professor, Department of Urology
“In April 2023, Fox Chase Cancer Center was among the first hospitals nationwide to open a large multi-site trial that examines effective new ways to treat newly diagnosed patients with high-risk non-muscle invasive bladder cancer, a need spurred by the long-standing shortage of BCG,” says Andres F. Correa, MD, Associate Professor, Department of Urology, Fox Chase Cancer Center and a Fox Chase-Temple Urologic Institute provider.
Patients with high-risk non-muscle invasive bladder cancer face the reality that their cancer may progress into muscle-invasive disease requiring life-changing treatments such as bladder removal or radiation. BCG has been the standard treatment for the prevention of cancer progression into the muscle for the last 30 years. Over the last 10 years, we have been affected by ongoing BCG shortages, which has limited our ability to treat patients per treatment guidelines, leading to an increase in the use of early bladder removal or alternative regimens.
The Phase III randomized trial compares Bacillus Calmette-Guérin (BCG) immunotherapy, the standard-of-care intravesical treatment for high-grade non-muscle invasive bladder cancer, versus intravesical Docetaxel and Gemcitabine treatment in BCG-naïve patients.
“Our great hope is that this 700-person trial demonstrates that the docetaxel-gemcitabine combination proves as effective as BCG, and that our reliance on it can end,” says Dr. Correa.
Eligibility: Patients must meet several criteria, including but not limited to:
- No prior or current history of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 90 days prior to randomization, which includes a CT Scan OR MRI of the abdomen/pelvis with intravenous contrast.
- Histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage) on transurethral resection of bladder tumor (TURBT) obtained within 90 days prior to randomization.