Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)

Launched by FOX CHASE CANCER CENTER · May 1, 2024

Keywords

ClinConnect Summary

The INSITE trial is studying a new way to better identify bladder tumors before surgery. Researchers want to see if combining three tests—looking directly inside the bladder, analyzing blood for tumor DNA, and examining urine for cancer-related DNA—can help predict if any tumors will remain during a planned surgery called cystectomy, where the bladder is removed. This study is important for patients with different types of bladder cancer, including those with invasive tumors and those who haven’t responded to other treatments.

To participate in this trial, patients should be at least 18 years old and have specific types of bladder cancer that require surgery. This includes patients with high-grade tumors that haven't gotten better with other treatments or those with more advanced muscle-invasive cancer. Participants will need to meet certain criteria, like being able to understand and sign consent forms. If you join the study, you can expect to undergo the combined testing approach before your surgery, which aims to provide more accurate information about your cancer. It's important to know that this study is only for patients who are having surgery with the intent to cure the cancer, not for those who are receiving palliative care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Properly counselled patients with high grade T1 disease who elect for cystectomy
• • 2. Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy
• • 3. cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy
• • 4. Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected).
• • 5. Male or female patients age \>=18 years at the time of consent.
• • 6. Able and willing to comply with study requirements.
• • 7. Patients must have a non-contrast phase component for CT scans of chest/abdomen/pelvis either pre-existing (prior to accrual) or obtained during the screening process.
• • 8. Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy.
• • 9. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document.
• Exclusion Criteria:
• • 1. Patients who undergo cystectomy with non-curative intent will be excluded.
• • 2. Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.
• • 3. Patients who are pregnant or nursing.