Prostatic Neoplasms, Castration-ResistantNCT07677267
A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan
An observational study of Prostatic Neoplasms, Castration-Resistant, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway inhibitor (ARPI), ≥1 taxane, and 177Lu-PSMA-617 in the United States (US) real-world clinical… Read more about this study
- Who is it for?
- Ages 18 to 115 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Castration-Resistant
- How many people
- 1,067 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 31 May 2027
- Phase
- Observational
- 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 115 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult male patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in the PRECISION data platform.
Who may be able to join
- Evidence of 177Lu-PSMA-617 use on or after 01 January 2021.
- Evidence of treatment with ≥1 ARPI, before 177Lu-PSMA-617.
- Evidence of treatment with ≥1 taxane, before or after 177Lu-PSMA-617.
- Diagnosis of mCRPC prior to or on the index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
- Age ≥18 years at index.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United States1 site, 1 recruiting
- Recruiting
Novartis
East Hanover, New Jersey, 07936
About this study
Official title: Real-World Characteristics, Treatment Patterns, and Outcomes Among Adults With mCRPC Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan
The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway inhibitor (ARPI), ≥1 taxane, and 177Lu-PSMA-617 in the United States (US) real-world clinical practice. This study will be conducted using data extracted from the PRECISION (PRostatE Cancer dISease observatION) data platform.
- Keywords
- Metastatic Castration-Resistant Prostate Cancer, Androgen Pathway Modulation-Resistant, APMR
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
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 mCRPC Cohort | Adult patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in PRECISION. | |
| mCRPC Progression Subgroup | A subgroup of the Overall mCRPC Cohort. Patients with evidence of progression on or after 177Lu-PSMA-617 treatment. | |
| ≥1 Subsequent Systemic Therapy Subgroup | A subgroup of the Overall mCRPC Cohort. Patients who initiate ≥1 post-index systemic therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date
The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Measured: Baseline
Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC)
Number of patients by number and type of prior ARPI, taxane, 177Lu-PSMA-617, and other therapies indicated for advanced PC.
Measured: Baseline
Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans
Measured: Baseline up to approximately 5 years
Number of Patients by Timing of PSMA Scans
Timing of scans is categorized as pre-mCRPC diagnosis, post-mCRPC diagnosis but pre-index date, and post-index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Measured: Baseline up to approximately 5 years
Number of Patients by Number of Post-index LOTs
Measured: Up to approximately 5 years
Number of Patients by Type of Therapy at Each Post-index LOT
Measured: Up to approximately 5 years
Time From Index Date to Next Therapy Initiation
The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Measured: Up to approximately 5 years
Secondary outcomes (8)
Number of Patients by Patient Characteristics
Patient characteristics include race, geographical region, insurance status, marital status, type of treatment center, comorbidities, Gleason score, disease stage at diagnosis, and prostate-specific antigen (PSA) level.
Measured: Baseline
Age
Measured: Baseline
Progression-free Survival (PFS) From Index Date
Time from the applicable index date until progression or death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Measured: Up to approximately 5 years
PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy
Time from the initiation of first post-index therapy until progression or death from any cause.
Measured: Up to approximately 5 years
Overall Survival (OS) From Index Date
Time from the applicable index date until death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Measured: Up to approximately 5 years
OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy
Time from initiation of first post-index therapy until death from any cause.
Measured: Up to approximately 5 years
Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level
Reduction in PSA level categorized as follows:
- ≥50% (PSA50) reduction in PSA level
- ≥80% (PSA80) reduction in PSA level
- ≥90% (PSA90) reduction in PSA level
Measured: Up to approximately 5 years
Among Patients With ≥1 Post-index Therapy, Number of Patients With PSA <0.2 ng/mL on First Post-index Therapy
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start30 Jun 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Neoplasms, Castration-ResistantStudies 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
- 1,067 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
- NCT07677267
- Sponsor's protocol ID
- CAAA617A1US30
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Characteristics, Treatment Patterns, and Outcomes Among Adults With mCRPC Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan
- ClinicalTrials.gov ID
- NCT07677267
- Acronym / sponsor ID
- CAAA617A1US30
- Keywords
- Metastatic Castration-Resistant Prostate Cancer, Androgen Pathway Modulation-Resistant, APMR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,067 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Jun 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 is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway inhibitor (ARPI), ≥1 taxane, and 177Lu-PSMA-617 in the United States (US) real-world clinical practice. This study will be conducted using data extracted from the PRECISION (PRostatE Cancer dISease observatION) data platform.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overall mCRPC Cohort | – | –Adult patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in PRECISION. |
| mCRPC Progression Subgroup | – | –A subgroup of the Overall mCRPC Cohort. Patients with evidence of progression on or after 177Lu-PSMA-617 treatment. |
| ≥1 Subsequent Systemic Therapy Subgroup | – | –A subgroup of the Overall mCRPC Cohort. Patients who initiate ≥1 post-index systemic therapy. |
Who may qualify
- Ages
- 18 to 115 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in the PRECISION data platform.
Key inclusion criteria (5 listed)
- Evidence of 177Lu-PSMA-617 use on or after 01 January 2021.
- Evidence of treatment with ≥1 ARPI, before 177Lu-PSMA-617.
- Evidence of treatment with ≥1 taxane, before or after 177Lu-PSMA-617.
- Diagnosis of mCRPC prior to or on the index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
- 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 Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date
Time frame: Baseline
The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC)
Time frame: Baseline
Number of patients by number and type of prior ARPI, taxane, 177Lu-PSMA-617, and other therapies indicated for advanced PC.
Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans
Time frame: Baseline up to approximately 5 years
Number of Patients by Timing of PSMA Scans
Time frame: Baseline up to approximately 5 years
Timing of scans is categorized as pre-mCRPC diagnosis, post-mCRPC diagnosis but pre-index date, and post-index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Number of Patients by Number of Post-index LOTs
Time frame: Up to approximately 5 years
Number of Patients by Type of Therapy at Each Post-index LOT
Time frame: Up to approximately 5 years
Time From Index Date to Next Therapy Initiation
Time frame: Up to approximately 5 years
The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
8 secondary outcomes
Number of Patients by Patient Characteristics
Time frame: Baseline
Age
Time frame: Baseline
Progression-free Survival (PFS) From Index Date
Time frame: Up to approximately 5 years
PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy
Time frame: Up to approximately 5 years
Overall Survival (OS) From Index Date
Time frame: Up to approximately 5 years
OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy
Time frame: Up to approximately 5 years
Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level
Time frame: Up to approximately 5 years
Among Patients With ≥1 Post-index Therapy, Number of Patients With PSA <0.2 ng/mL on First Post-index Therapy
Time frame: Up to approximately 5 years
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 15 Oct 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.
Novartis Pharmaceuticals contact
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 Prostatic Neoplasms, Castration-Resistant, 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 5 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 15 Oct 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?
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 (+41613241111, 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 of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date (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 15 Oct 2026.