A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of lutetium (177Lu) vipivotide tetraxetan in Adult Participants with Prostate Cancer

Phase 1

Recruiting

• Conditions: Prostate cancer; MedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-503208-94-00
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 704

Inclusion Criteria

Must have received at least one dose of AAA617 within an interventional, phase I-IV Novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study.

Exclusion Criteria

Inability to complete the needed investigational examinations due to any reason.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Further characterize the long-term outcome (for up to 10 years after the first dose of AAA617) of<br>1) known or potential risks of AAA617 including myelosuppression, renal failure, xerostomia, xerophthalmia, and secondary malignancies including myelodysplastic syndrome and acute myeloid leukemia (MDS/AML) and<br>2) other serious adverse reactions;Secondary Objective: Evaluate incidence of death;Primary end point(s): Incidence and proportion of participants with selected AEs and serious adverse events (SAEs), changes in laboratory values

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Incidence and proportion of death