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RecruitingPhase 4

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

A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study periods include a Baseline and Follow-up Period (up to 10 years after first dose of AAA617 in parent treatment study)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the long-term safety of lutetium (177Lu) vipivotide tetraxetan, also called AAA617. It tracks known or possible risks and serious side effects linked to the drug. It is for adults with prostate cancer who received at least one dose in a Novartis-sponsored clinical trial.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form agreeing to take part before joining the study.
  • Have received at least one dose of AAA617 in a Phase 1–4 Novartis-sponsored prostate cancer treatment trial.
  • Have met the earlier trial’s rules for joining this follow-up study.

Who can't join

  • Cannot complete the required study exams for any reason.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study * 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 sites (24)

AZ

CA

CO

  • University of Colorado · Aurora, CO 80045Muthiah Nachiappan · Principal investigatorMore trials in Aurora

CT

DC

FL

GA

IN

LA

MI

  • Corewell Health William Beaum Hosp · Royal Oak, MI 48073-6769Andrew Thompson · Principal investigatorMore trials in Royal Oak

MN

MO

MS

NC

  • Duke University Medical Center · Durham, NC 27710Daniel J George · Principal investigatorMore trials in Durham

NE

NY

OH

PA

TX

  • Univ of Texas Southwest Med Center · Dallas, TX 75390-9034Kevin Courtney · Principal investigatorMore trials in Dallas
  • UT Health Science Center · Houston, TX 77030Bo Chen · Principal investigatorMore trials in Houston

VA