Recruiting PHASE4 Prostate Cancer

Tests treatment safety and results for Prostate Cancer

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

ClinicalTrials.gov ID: NCT05803941

What this study is testing

What is AAA617?

AAA617 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.

Also referred to as lutetium (177Lu) vipivotide tetraxetan, [177Lu]Lu-PSMA-617.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 100, men only

You may be able to join if

  • Signed informed consent must be obtained prior to participation in the study
  • Must have received at least one dose of AAA617 within an treatment, Phase I-IV Novartis sponsored clinical trial in prostate cancer and have...

You likely can't join if

  • \- Inability to complete the needed investigational examinations due to any reason.

The study team makes the final eligibility decision.

Where it's taking place

  • Scottsdale, Arizona, United States
  • Orange, California, United States
  • Santa Monica, California, United States
  • Aurora, Colorado, United States
  • Hartford, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Jacksonville, Florida, United States
  • Athens, Georgia, United States
  • Fort Wayne, Indiana, United States
  • New Orleans, Louisiana, United States
  • Royal Oak, Michigan, United States
  • Rochester, Minnesota, United States
  • Jackson, Mississippi, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • The Bronx, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Dallas, Texas, United States

+ 28 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18 years to 100 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Scottsdale, Arizona, United States; Orange, California, United States; Santa Monica, California, United States; Aurora, Colorado, United States; Hartford, Connecticut, United States; Washington D.C., District of Columbia, United States and 42 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.