THIS SITE IS INTENDED FOR US HEALTHCARE PROFESSIONALS
Approximately 50 urology sites in the United States (US) and Israel.
See ABLE-41 information on clinicaltrials.gov NCT Number: NCT06026332
Study Start (Actual) 09-15-2023
Primary Completion (Estimated) 12-31-2025
Study Completion (Estimated) 12-31-2025
Enrollment 200-400 participants
Study Type Observational
It is expected that the minimum follow-up period is 24 months or until study discontinuation or withdrawal.
PRIMARY OBJECTIVE
To assess the effectiveness of ADSTILADRIN measured as complete response (CR) rate as determined by the investigator in a real-world setting.
ENDPOINTS
All endpoints will be assessed in patients with high-grade Ta/T1 alone, carcinoma in situ (CIS) alone, CIS along with any grade Ta/T1, and overall cohort.
PRIMARY ENDPOINT:
Co-Primary Endpoints:
• Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves complete response (CR) at first evaluation from first ADSTILADRIN instillation
• Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves CR at any time within 1 year from first ADSTILADRIN instillation
Hospitals or clinical sites with urology representation and access to ADSTILADRIN will enroll patients who meet inclusion and exclusion criteria. Of note, a patient that requires ADSTILADRIN as per their treating physician discretion, will receive ADSTILADRIN regardless of the patient decision to participate in this study.
Study personnel will obtain dated and signed informed consent form (ICF) for patients and patients’
caregivers before participation in this study. Patient-level data will be abstracted onto an electronic
case report form (eCRF) according to the data collection schedule.
NUMBER OF PATIENTS
The number of patients to include in the study will depend on ADSTILADRIN uptake after commercialization from September 2023 to December 2024. Based on a recruitment rate of 0.23 patients/month/center in a Phase 3 trial in the US and the number of centers expected to be included in this study, it is expected that between 200 and 400 patients will be enrolled in the study.
CRITERIA FOR INCLUSION / EXCLUSION
Inclusion Criteria:
• Prescribed and scheduled treatment with ADSTILADRIN per physician discretion, or received the first instillation of ADSTILADRIN per physician discretion after 5 September 2023 but prior to site activation
• Signed and dated ICF
• Age 18 years or older on the day ICF is signed
Exclusion Criteria:
• Currently enrolled in a clinical trial
• Patients who have previously been treated with ADSTILADRIN in the context of a clinical trial
• Patient is pregnant or breastfeeding
DURATION OF PARTICIPATION
Patients are expected to participate in the study for at least 24 months.
Patients’ caregivers are expected to participate in the study for at least 24 months.
Physicians participating in this registry will be surveyed at three timepoints: 1 month following first patient first instillation of ADSTILADRIN, or as soon as possible upon site activation, and at 12 and 24 months post first patient first instillation at each respective site.
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
STUDY CONTACT
Name: Lindy Bancke, PharmD
Email: Lindy.Bancke@ferring.com
STUDY CONTACT BACKUP
Name: Global Clinical Compliance
Phone Number:+1 862-286-5200 (outside US)
Email: DK0-Disclosure@ferring.com