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Long-term safety monitoring of a prostate cancer treatment

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 4 Interventional Novartis · NCT05803941

This study is checking the long-term safety of a prostate cancer treatment called lutetium (177Lu) vipivotide tetraxetan in adults who have already received it to see how they are doing over time.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years to 100 Years
SexMale
SponsorNovartis Industry-sponsored
Locations54 sites (Scottsdale, Arizona and 53 other locations)
Trial IDNCT05803941 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the long-term safety of lutetium (177Lu) vipivotide tetraxetan, also known as AAA617, in adults who have previously received this treatment for prostate cancer. Participants will be monitored every 6 to 8 months for up to 10 years to assess any serious adverse events and laboratory parameters related to the treatment. The study is a global, prospective, multi-center follow-up that does not involve administering any new treatments, focusing instead on the long-term outcomes of those who have already participated in earlier clinical trials. Enrollment requires participants to have completed the necessary follow-up from their initial treatment studies.

Who should consider this trial

Good fit: Ideal candidates are adults with prostate cancer who have previously received at least one dose of AAA617 in a Novartis-sponsored clinical trial.

Not a fit: Patients who have not received AAA617 or those unable to complete the required follow-up examinations will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety profile of AAA617, helping to inform future treatment decisions for prostate cancer patients.

How similar studies have performed: Other studies have shown success in monitoring long-term safety for similar treatments, indicating that this approach is both relevant and necessary.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Scottsdale, Arizona and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate CancerLong-Term Safety Follow-Up177Lu-PSMA-617[177Lu]Lu-PSMA-617lutetium vipivotide tetraxetanAAA617parent treatment study
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.