This study is a two-arm phase II randomized trial investigating patients with luminal subtype muscle-invasive bladder cancer (MIBC) receiving neoadjuvant therapy (NAT) followed by cystectomy compared to those receiving upfront cystectomy.
The goal of this study is to assess the feasibility and oncologic safety of upfront radical cystectomy in luminal MIBC, using pathological upstaging (pT3-4 or pN+) and efficacy as the primary safety endpoints. For patients with muscle-invasive bladder cancer (MIBC), the standard treatment remains sequential neoadjuvant therapy (NAT), which may include either cisplatin-based chemotherapy or novel approved combination regimens (i.e., chemotherapy and immunotherapy) followed by cystectomy. Although NAT improves overall survival, individual patient responses are heterogeneous (meaning not all patients experience the same benefit), and patients often experience morbidity. In this study, the investigators will use the commercially available GSC- Decipher Bladder to analyze tumor tissue and determine the genomic subtype (luminal or basal). Additionally, circulating tumor cell DNA (ctDNA) will be assessed at several time points in patients receiving NAT followed by RC, compared with those receiving upfront cystectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients will undergo standard of care neoadjuvant therapy followed by radical cystectomy
Patients will undergo upfront radical cystectomy without neoadjuvant therapy
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
RECRUITING: Pathological upstaging rate at radical cystectomy (pT3-pT4 or pN+)
Percentage of evaluable participants in each study arm who are pathologically upstaged from clinical stage cT2N0 disease to pathological stage pT3-pT4 or pN+ disease, based on examination of the radical cystectomy specimen.
Time frame: At the time of radical cystectomy
Change From Baseline in Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) Bladder Cancer Subscale (BlCS) Score
Change From Baseline in Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) Bladder Cancer Subscale (BlCS) Score
Time frame: Baseline and 1, 3, and 6 months after radical cystectomy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.