Prostate CancerNCT07450157
A Study of Patient Characteristics, Treatment Patterns and Outcomes Among Patients Treated With 177Lu-PSMA-617
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 evaluate patient characteristics, treatment patterns, prostate-specific antigen (PSA) reduction, and overall survival (OS) of prostate cancer patients treated with 177-Lutetium-Prostate-Specific Membrane Antigen-617 (177Lu-PSMA-617). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 6,448 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 28 Feb 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with electronic health care records in multiple databases who were treated with 177Lu-PSMA-617.
Who may be able to join
None listed.
Who cannot join
- 1. Standard data cleaning processes were applied to remove patients with data quality issues. Specific data quality issues included missing or invalid age or sex.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Characteristics, Treatment Patterns and Outcomes Among Early Adopters of 177Lu-PSMA-617: An Early View Claims Data Study
The aim of this study was to evaluate patient characteristics, treatment patterns, prostate-specific antigen (PSA) reduction, and overall survival (OS) of prostate cancer patients treated with 177-Lutetium-Prostate-Specific Membrane Antigen-617 (177Lu-PSMA-617). Patient data from multiple electronic health record databases, including claims (open-source medical and pharmacy claims), consumer attributes, mortality, and laboratory data linked to claims databases was used.
The study analysis was conducted in two phases. Phase I provided an early view of patients treated with 177Lu-PSMA-617 shortly after launch. Phase II refreshed the data, added mortality and extracted additional years of historical data to allow for the identification of the initial metastatic castrate-resistant prostate cancer (mCRPC) diagnosis and follow-up from that date through the start of 177Lu-PSMA-617.
- Conditions
- Prostate Cancer
- Keywords
- Metastatic castrate-resistant prostate cancer, Treatment patterns, Treatment response, Overall survival
- 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 |
|---|---|---|
| 177Lu-PSMA-617 Patients Meeting Minimum Study Criteria | Phase I analysis group. Adult patients treated with 177Lu-PSMA-617 who met the minimum study criteria. | |
| 177Lu-PSMA-617 Patients with Pre- and Post-PSA Data Available | Phase I analysis group. Adult patients who met the minimum study criteria and had at least one PSA result available 28 days or more after the index date (177Lu-PSMA-617 initiation) while still on 177Lu-PSMA-617 treatment. | |
| Patients who Received 177Lu-PSMA-617 at Anytime During the Study Period | Phase II analysis group. Adult patients with mCRPC who initiated 177Lu-PSMA-617 between 01 July 2014 and 30 September 2024 (index period). | |
| Post-mCRPC 177Lu-PSMA-617 (≥6 Months Continuous Enrollment) | Phase II analysis group. Adult patients with continuous enrollment (CE) between the mCRPC diagnosis date and initiating 177Lu-PSMA-617 (index date), and at least 6 months of CE prior to the index date. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients by Demographic Category
Demographics included:
- Age group
- Geographical region
- Payer type
- Physician specialty
- Race/ethnicity
- Education level
- Occupation
Measured: Baseline
Number of Patients by Clinical Characteristic Category
Clinical characteristics included:
- National Cancer Institute (NCI) comorbidity index
- NCI category
- Comorbidities
- Metastasis sites
- Number of distinct metastatic sites
- PSA level category (≤ 4 ng/ml, > 4 ng/ml)
Measured: Baseline
Clinical Characteristic: Baseline PSA Level
Measured: Baseline
Overall Survival (OS)
OS was defined as the time from mCRPC diagnosis until death.
Measured: Up to approximately 10 years
Number of Patients who Died Within 6, 12, 24, and 36 Months From the mCRPC Diagnosis Date
Measured: 6, 12, 24, and 36 months
Survival Time After the Last Administration of 177Lu-PSMA-617
Measured: Up to approximately 10 years
Number of Patients who Died After the Last Administration of 177Lu-PSMA-617
Measured: Up to approximately 10 years
Secondary outcomes (10)
Percentage of Patients by Treatments Received From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617
Measured: Up to approximately 10 years
Percentage of Patients by Line of 177Lu-PSMA-617 Initiation
Measured: Up to approximately 10 years
Percentage of Patients by Sequence of Treatments Prior to 177Lu-PSMA-617 Treatment
Measured: Baseline
Duration of Each Line of Treatment (LOT) by Treatment Received
Measured: Up to approximately 10 years
Time From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617
Measured: Up to approximately 10 years
177Lu-PSMA-617 Treatment Duration
Measured: Up to approximately 10 years
Percentage of Patients Still on 177Lu-PSMA-617 Therapy at 3, 6, 9, and 12 Months After Initiation of 177Lu-PSMA-617
Measured: 3, 6, 9, and 12 Months
Percentage of Patients by Number of 177Lu-PSMA-617 Cycles
Measured: Up to approximately 10 years
Time to Next Treatment (TTNT)
TTNT was defined as time from the start of 177Lu-PSMA-617 therapy to the initiation of a new LOT.
Measured: Up to approximately 10 years
Number of Patients With a Change in PSA Levels While on 177Lu-PSMA-617 by Percent Reduction in PSA
Reduction in PSA was categorized as ≥50%, ≥80%, and ≥90%.
Measured: 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 posted4 Mar 2026
- Study start23 Jun 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 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
- 6,448 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
- NCT07450157
- Sponsor's protocol ID
- CAAA617A1US19
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Characteristics, Treatment Patterns and Outcomes Among Early Adopters of 177Lu-PSMA-617: An Early View Claims Data Study
- ClinicalTrials.gov ID
- NCT07450157
- Acronym / sponsor ID
- CAAA617A1US19
- Conditions
- Prostate Cancer
- Keywords
- Metastatic castrate-resistant prostate cancer, Treatment patterns, Treatment response, Overall survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,448 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 4 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 evaluate patient characteristics, treatment patterns, prostate-specific antigen (PSA) reduction, and overall survival (OS) of prostate cancer patients treated with 177-Lutetium-Prostate-Specific Membrane Antigen-617 (177Lu-PSMA-617). Patient data from multiple electronic health record databases, including claims (open-source medical and pharmacy claims), consumer attributes, mortality, and laboratory data linked to claims databases was used.
The study analysis was conducted in two phases. Phase I provided an early view of patients treated with 177Lu-PSMA-617 shortly after launch. Phase II refreshed the data, added mortality and extracted additional years of historical data to allow for the identification of the initial metastatic castrate-resistant prostate cancer (mCRPC) diagnosis and follow-up from that date through the start of 177Lu-PSMA-617.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 177Lu-PSMA-617 Patients Meeting Minimum Study Criteria | – | –Phase I analysis group. Adult patients treated with 177Lu-PSMA-617 who met the minimum study criteria. |
| 177Lu-PSMA-617 Patients with Pre- and Post-PSA Data Available | – | –Phase I analysis group. Adult patients who met the minimum study criteria and had at least one PSA result available 28 days or more after the index date (177Lu-PSMA-617 initiation) while still on 177Lu-PSMA-617 treatment. |
| Patients who Received 177Lu-PSMA-617 at Anytime During the Study Period | – | –Phase II analysis group. Adult patients with mCRPC who initiated 177Lu-PSMA-617 between 01 July 2014 and 30 September 2024 (index period). |
| Post-mCRPC 177Lu-PSMA-617 (≥6 Months Continuous Enrollment) | – | –Phase II analysis group. Adult patients with continuous enrollment (CE) between the mCRPC diagnosis date and initiating 177Lu-PSMA-617 (index date), and at least 6 months of CE prior to the index date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with electronic health care records in multiple databases who were treated with 177Lu-PSMA-617.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1. Standard data cleaning processes were applied to remove patients with data quality issues. Specific data quality issues included missing or invalid age or sex.
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 Demographic Category
Time frame: Baseline
Demographics included: * Age group * Geographical region * Payer type * Physician specialty * Race/ethnicity * Education level * Occupation
Number of Patients by Clinical Characteristic Category
Time frame: Baseline
Clinical characteristics included: * National Cancer Institute (NCI) comorbidity index * NCI category * Comorbidities * Metastasis sites * Number of distinct metastatic sites * PSA level category (≤ 4 ng/ml, > 4 ng/ml)
Clinical Characteristic: Baseline PSA Level
Time frame: Baseline
Overall Survival (OS)
Time frame: Up to approximately 10 years
OS was defined as the time from mCRPC diagnosis until death.
Number of Patients who Died Within 6, 12, 24, and 36 Months From the mCRPC Diagnosis Date
Time frame: 6, 12, 24, and 36 months
Survival Time After the Last Administration of 177Lu-PSMA-617
Time frame: Up to approximately 10 years
Number of Patients who Died After the Last Administration of 177Lu-PSMA-617
Time frame: Up to approximately 10 years
10 secondary outcomes
Percentage of Patients by Treatments Received From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617
Time frame: Up to approximately 10 years
Percentage of Patients by Line of 177Lu-PSMA-617 Initiation
Time frame: Up to approximately 10 years
Percentage of Patients by Sequence of Treatments Prior to 177Lu-PSMA-617 Treatment
Time frame: Baseline
Duration of Each Line of Treatment (LOT) by Treatment Received
Time frame: Up to approximately 10 years
Time From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617
Time frame: Up to approximately 10 years
177Lu-PSMA-617 Treatment Duration
Time frame: Up to approximately 10 years
Percentage of Patients Still on 177Lu-PSMA-617 Therapy at 3, 6, 9, and 12 Months After Initiation of 177Lu-PSMA-617
Time frame: 3, 6, 9, and 12 Months
Percentage of Patients by Number of 177Lu-PSMA-617 Cycles
Time frame: Up to approximately 10 years
Time to Next Treatment (TTNT)
Time frame: Up to approximately 10 years
Number of Patients With a Change in PSA Levels While on 177Lu-PSMA-617 by Percent Reduction in PSA
Time frame: 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 4 Mar 2026.
- 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 0 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 4 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 Demographic Category (time frame: Baseline). The study lists 7 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 4 Mar 2026.