Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• AAA617 — DRUG
  Long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from parent interventional Novartis sponsored clinical trials.

Study Details

The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.

Key Dates

Start date

Aug 14, 2023

Status verified

Jun 2026

Primary completion

Jul 20, 2033

Completion

Jul 21, 2033

Study Design

Enrollment

700 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Other: Single arm
  Participants will be followed until death, lost to follow-up, or up to 10 years from first dose of AAA617, whichever occurs first. There will be no study treatment administered to participants while participating in this study.

Primary Outcome Measure

Number and percentage of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111
  [email protected]

Locations (24)

Find similar trials in Scottsdale, AZ

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