Prostate CancerNCT07477756
A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients
An observational study of Prostate Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The aim of this study was to assess the characteristics, treatment patterns, and clinical outcomes among metastatic castration-resistant prostate cancer (mCRPC) patients in the United States (US) who were treated with lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) in the real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- How many people
- 1,247 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 14 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with evidence of treatment with 177Lu-PSMA-617.
Who may be able to join
- Evidence of 177Lu-PSMA-617 use on or after March 23, 2022
- Date of initiation of 177Lu-PSMA-617 available in the data
- Age ≥18 years at index
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients Receiving Lutetium-177 Vipivotide Tetraxetan
The aim of this study was to assess the characteristics, treatment patterns, and clinical outcomes among metastatic castration-resistant prostate cancer (mCRPC) patients in the United States (US) who were treated with lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) in the real-world setting.
- Conditions
- Prostate Cancer
- Keywords
- Lutetium-177 (177Lu) Vipivotide Tetraxetan, 177Lu-PSMA-617, Clinical Outcomes, Prostate Cancer, Prostate-specific Antigen, Metastatic Castration-resistant Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Overall 177Lu-PSMA-617 Cohort | All patients treated with 177Lu-PSMA-617. | |
| Prior Treatment Use Cohort: ≥1 Androgen Receptor Pathway Inhibitor (ARPI) and ≥1 Taxane | Patients treated with 177Lu-PSMA-617 after at least 1 ARPI and at least 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel. | |
| Prior Treatment Use Cohort: 1 ARPI and 1 Taxane | Patients treated with 177Lu-PSMA-617 after 1 ARPI and 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel. | |
| Prior Treatment Use Cohort: Delayed | Patients with evidence of 1 ARPI and 1 taxane treatment plus at least 1 additional ARPI or taxane before 177Lu-PSMA-617 initiation. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel. | |
| Subsequent Treatment Use Cohort: Any Guideline-Recommended Treatment | Patients treated with any guideline-recommended treatment for mCRPC after 177Lu-PSMA-617 discontinuation. Guideline-recommended treatments include abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, radium-223; carboplatin, cisplatin, etoposide, and mitoxantrone. | |
| Subsequent Treatment Use Cohort: ARPI/Taxane | Patients treated with any ARPI or taxane after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel). | |
| Subsequent Treatment Use Cohort: ARPI | Patients treated with any ARPI after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide). | |
| Subsequent Treatment Use Cohort: Taxane | Patients treated with any taxane after 177Lu-PSMA-617 discontinuation (i.e., cabazitaxel, docetaxel). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients by Patient Characteristic
Patient characteristics included:
- Age
- Race
- Marital status
- Insurance status
- Practice type
- Physician specialty
- Geographic region
- Have a Gleason score ≤1 year of index
- Gleason score (<7, ≥7)
- Have a prostate-specific antigen (PSA) test ≤1 year of index
- PSA level (elevated, normal, unknown)
Measured: Baseline
Mean PSA Level
Measured: Baseline
Number of Patients by Number of ARPIs and Taxanes Received Before 177Lu-PSMA-617 Treatment Initiation
Measured: Baseline
Number of Patients by Number of Doses of 177Lu-PSMA-617 Treatment From Initiation Until Discontinuation
Measured: Up to approximately 2 years
Duration of 177Lu-PSMA-617 Treatment
Measured: Up to approximately 2 years
Number and Percentage of Patients Initiating ARPIs, Taxanes, and Other Guideline-recommended Therapies for mCRPC After 177Lu-PSMA-617 Discontinuation
Measured: Up to approximately 2 years
Secondary outcomes (1)
Number and Percentage of Patients With a Reduction in PSA Level
Reduction in PSA level was categorized as follows:
- ≥50% (PSA50) reduction in PSA level
- ≥80% (PSA80) reduction in PSA level
- ≥90% (PSA90) reduction in PSA level
Measured: Baseline up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start4 Sep 2024
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,247 participants (actual)
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
- NCT07477756
- Sponsor's protocol ID
- CAAA617A1US13
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients Receiving Lutetium-177 Vipivotide Tetraxetan
- ClinicalTrials.gov ID
- NCT07477756
- Acronym / sponsor ID
- CAAA617A1US13
- Conditions
- Prostate Cancer
- Keywords
- Lutetium-177 (177Lu) Vipivotide Tetraxetan, 177Lu-PSMA-617, Clinical Outcomes, Prostate Cancer, Prostate-specific Antigen, Metastatic Castration-resistant Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,247 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 17 Mar 2026 (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 aim of this study was to assess the characteristics, treatment patterns, and clinical outcomes among metastatic castration-resistant prostate cancer (mCRPC) patients in the United States (US) who were treated with lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) in the real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Overall 177Lu-PSMA-617 Cohort | – | –All patients treated with 177Lu-PSMA-617. |
| Prior Treatment Use Cohort: ≥1 Androgen Receptor Pathway Inhibitor (ARPI) and ≥1 Taxane | – | –Patients treated with 177Lu-PSMA-617 after at least 1 ARPI and at least 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel. |
| Prior Treatment Use Cohort: 1 ARPI and 1 Taxane | – | –Patients treated with 177Lu-PSMA-617 after 1 ARPI and 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel. |
| Prior Treatment Use Cohort: Delayed | – | –Patients with evidence of 1 ARPI and 1 taxane treatment plus at least 1 additional ARPI or taxane before 177Lu-PSMA-617 initiation. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel. |
| Subsequent Treatment Use Cohort: Any Guideline-Recommended Treatment | – | –Patients treated with any guideline-recommended treatment for mCRPC after 177Lu-PSMA-617 discontinuation. Guideline-recommended treatments include abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, radium-223; carboplatin, cisplatin, etoposide, and mitoxantrone. |
| Subsequent Treatment Use Cohort: ARPI/Taxane | – | –Patients treated with any ARPI or taxane after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel). |
| Subsequent Treatment Use Cohort: ARPI | – | –Patients treated with any ARPI after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide). |
| Subsequent Treatment Use Cohort: Taxane | – | –Patients treated with any taxane after 177Lu-PSMA-617 discontinuation (i.e., cabazitaxel, docetaxel). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with evidence of treatment with 177Lu-PSMA-617.
Key inclusion criteria (3 listed)
- Evidence of 177Lu-PSMA-617 use on or after March 23, 2022
- Date of initiation of 177Lu-PSMA-617 available in the data
- Age ≥18 years at index
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients by Patient Characteristic
Time frame: Baseline
Patient characteristics included: * Age * Race * Marital status * Insurance status * Practice type * Physician specialty * Geographic region * Have a Gleason score ≤1 year of index * Gleason score (<7, ≥7) * Have a prostate-specific antigen (PSA) test ≤1 year of index * PSA level (elevated, normal, unknown)
Mean PSA Level
Time frame: Baseline
Number of Patients by Number of ARPIs and Taxanes Received Before 177Lu-PSMA-617 Treatment Initiation
Time frame: Baseline
Number of Patients by Number of Doses of 177Lu-PSMA-617 Treatment From Initiation Until Discontinuation
Time frame: Up to approximately 2 years
Duration of 177Lu-PSMA-617 Treatment
Time frame: Up to approximately 2 years
Number and Percentage of Patients Initiating ARPIs, Taxanes, and Other Guideline-recommended Therapies for mCRPC After 177Lu-PSMA-617 Discontinuation
Time frame: Up to approximately 2 years
1 secondary outcome
Number and Percentage of Patients With a Reduction in PSA Level
Time frame: Baseline up to approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients by Patient Characteristic (time frame: Baseline). The study lists 6 primary outcomes in all. 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 19 Mar 2026.