Prostate CancerPhase 4NCT05803941
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
A Phase 4 study testing AAA617 in people with Prostate Cancer, run by Novartis Pharmaceuticals at 54 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- AAA617
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 54 sitesin 11 countries
- Study dates
- 14 Aug 2023to 21 Jul 2033
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to complete the needed investigational examinations due to any reason.
Trial locations and contacts
54 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
54 sites in 11 countries
United States24 sites, 24 recruiting
- Recruiting
University Cancer and Blood Center LLC
Athens, Georgia, 30607
706-353-2990
Petros Nikolinakos
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Muthiah Nachiappan
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
216-444-0441
Shilpa Gupta
- Recruiting
Univ of Texas Southwest Med Center
Dallas, Texas, 75390-9034
Kevin Courtney
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Daniel J George
- Recruiting
Parkview Research Center
Fort Wayne, Indiana, 46845
Brian Chang
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Andrew Salner
- Recruiting
UT Health Science Center
Houston, Texas, 77030
Bo Chen
- Recruiting
University of Mississippi Med Ctr
Jackson, Mississippi, 39216
+1 601 815 5374
John Clark Henegan
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Winston Tan
- Recruiting
Tulane Cancer Center
New Orleans, Louisiana, 70112
504-585-6077
Brian Lewis
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
504-842-6044
Stephen Bardot
- Recruiting
Urology Cancer Center PC
Omaha, Nebraska, 68130
402-697-2229
Luke Nordquist
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68154
Ralph Hauke
- Recruiting
St. Joseph Hospital
Orange, California, 92686
Timothy Byun
- Recruiting
Univ of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Leonard Appleman
- Recruiting
Onco Hemato Asso of SW Virginia
Roanoke, Virginia, 24014
540-774-8660
David Buck
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Brian Costello
- Recruiting
Corewell Health William Beaum Hosp
Royal Oak, Michigan, 48073-6769
Andrew Thompson
- Recruiting
Providence Saint Johns Health Ctr
Santa Monica, California, 90404
Przemyslaw Twardowski
- Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
480-301-8300
Cassandra Moore
- Recruiting
Wash U School of Medicine
St Louis, Missouri, 63110
Lindsey Mayer, lindseymayer@wustl.edu
Hyun Kim
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Benjamin A Gartrell
- Recruiting
VA Medical Center
Washington D.C., District of Columbia, 20422
202-745-8457
Frank Liu
Spain10 sites, 10 recruiting
- Recruiting
Novartis Investigative Site
Barcelona, 08035
- Recruiting
Novartis Investigative Site
Barcelona, 08036
- Recruiting
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
- Recruiting
Novartis Investigative Site
Madrid, 28034
- Recruiting
Novartis Investigative Site
Madrid, 28040
- Recruiting
Novartis Investigative Site
Madrid, 28041
- Recruiting
Novartis Investigative Site
Madrid, 28046
- Recruiting
Novartis Investigative Site
Majadahonda, Madrid, 28222
- Recruiting
Novartis Investigative Site
Sabadell, Barcelona, 08208
- Recruiting
Novartis Investigative Site
Valencia, 46026
United Kingdom5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Barnet, EN5 3DJ
- Recruiting
Novartis Investigative Site
Cambridge, CB2 0QQ
- Recruiting
Novartis Investigative Site
Glasgow, G12 0YN
- Recruiting
Novartis Investigative Site
Middlesbrough, TS4 3BW
- Recruiting
Novartis Investigative Site
Sutton, Surrey, SM2 5PT
Germany3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Essen, 45147
- Recruiting
Novartis Investigative Site
München, 80377
- Recruiting
Novartis Investigative Site
Rostock, 18057
Netherlands3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Delft, South Holland, 2625 AD
- Recruiting
Novartis Investigative Site
Maastricht, Limburg, 6229 HX
- Recruiting
Novartis Investigative Site
Nijmegen, Gelderland, 6500HB
Austria2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Linz, 4020
- Recruiting
Novartis Investigative Site
Vienna, 1090
Czechia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Olomouc, 779 00
- Recruiting
Novartis Investigative Site
Prague, 150 06
Sweden2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Gothenburg, 413 45
- Recruiting
Novartis Investigative Site
Stockholm, 17176
Canada1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H2X 1R9
About this study
Official title: A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
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.
Read the detailed description
This is a global, prospective, multi-center, long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.
There will be no study treatment administered to participants in this study. Participants will have visits every 6-8 months for monitoring of selected AEs and laboratory parameters. The study periods include a Baseline and Follow-up Period (up to 10 years after first dose of AAA617 in parent treatment study).
Participants should enroll into the LTFU study after parent treatment study requirements are fulfilled (refer to the parent treatment study protocol for requirements, including any additional requirements after participant enters this LTFU safety study).
The schedule of activities for this LTFU study is designed to start from date of informed consent for this LTFU study. Participants should be followed every 6 to 8 months for up to a total of 10 years starting from first dose of AAA617 in the parent treatment study. Participants entering the LTFU study will have already completed a variable portion of the required 10-year follow-up within the parent treatment study. The specific number of visits required in this LTFU study will depend upon the time of enrollment into this LTFU study following the first dose of AAA617 in the parent treatment study.
The total number of participants to be enrolled and the duration of this LTFU study will depend upon the total number treated in the parent treatment studies and their duration.
- Conditions
- Prostate Cancer
- Being tested
- AAA617
- Keywords
- Prostate Cancer, Long-Term Safety Follow-Up, 177Lu-PSMA-617, [177Lu]Lu-PSMA-617, lutetium (177Lu) vipivotide tetraxetan, AAA617, parent treatment study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAA617Drug
Also called lutetium (177Lu) vipivotide tetraxetan, [177Lu]Lu-PSMA-617, 177Lu-PSMA-617
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 group | Role | What they receive |
|---|---|---|
| Single arm | Other | 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. Receives: Drug: AAA617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs)
Selected adverse events (AEs) include xerostomia, xerophtalmia, myelosupression, renal toxicity and second primary malignancy and their complication. Only SAEs considered causally related to previous treatment with AAA617 will be considered.
Measured: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study
Secondary outcomes (2)
Number and percentage of participants who have died
The number and percentage of participants who die during the long-term follow-up will be summarized.
Measured: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study
Absorbed radiation dose in kidney or other selected organs and number of AEs
Correlation between absorbed radiation dose in kidney or selected organs and safety of AAA617 for participants with dosimetry estimates collected in the parent treatment study.
Measured: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start14 Aug 2023
- Primary completion20 Jul 2033 (estimated)
- Study completion21 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803941
- Sponsor's protocol ID
- CAAA617A12402
- Other IDs
- 2023-503208-94-00, 2023
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
- ClinicalTrials.gov ID
- NCT05803941
- Acronym / sponsor ID
- CAAA617A12402
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Long-Term Safety Follow-Up, 177Lu-PSMA-617, [177Lu]Lu-PSMA-617, lutetium (177Lu) vipivotide tetraxetan, AAA617, parent treatment study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 20 Jul 2033 (estimated)
- Study completion
- 21 Jul 2033 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a global, prospective, multi-center, long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.
There will be no study treatment administered to participants in this study. Participants will have visits every 6-8 months for monitoring of selected AEs and laboratory parameters. The study periods include a Baseline and Follow-up Period (up to 10 years after first dose of AAA617 in parent treatment study).
Participants should enroll into the LTFU study after parent treatment study requirements are fulfilled (refer to the parent treatment study protocol for requirements, including any additional requirements after participant enters this LTFU safety study).
The schedule of activities for this LTFU study is designed to start from date of informed consent for this LTFU study. Participants should be followed every 6 to 8 months for up to a total of 10 years starting from first dose of AAA617 in the parent treatment study. Participants entering the LTFU study will have already completed a variable portion of the required 10-year follow-up within the parent treatment study. The specific number of visits required in this LTFU study will depend upon the time of enrollment into this LTFU study following the first dose of AAA617 in the parent treatment study.
The total number of participants to be enrolled and the duration of this LTFU study will depend upon the total number treated in the parent treatment studies and their duration.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: AAA617Participants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to complete the needed investigational examinations due to any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAA617Also: lutetium (177Lu) vipivotide tetraxetan, [177Lu]Lu-PSMA-617, 177Lu-PSMA-617Long-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. | Drug | Single arm |
Primary outcome
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
Selected adverse events (AEs) include xerostomia, xerophtalmia, myelosupression, renal toxicity and second primary malignancy and their complication. Only SAEs considered causally related to previous treatment with AAA617 will be considered.
2 secondary outcomes
Number and percentage of participants who have died
Time frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study
Absorbed radiation dose in kidney or other selected organs and number of AEs
Time frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
54 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AAA617 in people with Prostate Cancer, run by Novartis Pharmaceuticals at 54 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Spain, United Kingdom, Germany, Netherlands and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.