Castration-Resistant Prostatic CancerNCT07843758
An External Control Arm Study Comparing Survival Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With 177Lu-PSMA-617 vs Androgen Receptor Pathway Inhibitor (ARPI) Switch in Routine Care
An observational study of Castration-Resistant Prostatic Cancer, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
The aim of this study is to assess the effectiveness of 177Lu-PSMA-617 (lutetium (177Lu) vipivotide tetraxetan) on survival in patients randomized to receive treatment following progression on one ARPI from the PSMAfore trial compared to the effectiveness of a change in ARPI treatment on survival in a real-world… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Castration-Resistant Prostatic Cancer
- How many people
- 1,525 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2024to 1 Oct 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: PSMAfore trial patients with mCRPC who progressed once after treatment with an ARPI and were taxane-naive, and real-world data (RWD) mCRPC patients from the United States (US)-based health research database who were taxane-naive and had evidence of treatment with a change in ARPI immediately following progression.
Who may be able to join
- Had an International Classification of Diseases, 9th or 10th Revision, Clinical Modification (ICD-9-CM or ICD-10-CM) diagnosis of prostate cancer (PC) (ICD-9-CM 185x or ICD-10-CM C61x).
- Had at least two documented clinical visits, on different days, occurring on or after 01 Jan 2013.
- Included in probabilistic sample of patients queued for review via abstraction.
- Had diagnosis of metastatic disease on or after 01 Jan 2013.
- Histology was confirmed as adenocarcinoma of the prostate.
- Had confirmed mCRPC diagnosis.
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- Treated with an ARPI-containing line of therapy (LOT; i.e., index therapy) in the mCRPC setting immediately after progression on one previous ARPI-containing line (in any setting, Hormone Sensitive PC or castration-resistant PC), as defined per the health research database's LOT rules and confirmed via abstraction.
- 18 years of age or older at the start of index therapy.
- Had an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0-1 within 30 days before or up to 7 days after index date, or unknown ECOG PS.
Who cannot join
- Female sex.
- Had evidence of untreated brain metastases.
- Had history of cardiac comorbidities, infection with hepatitis B or C, or spinal cord compression that would indicate significant risk to PSMAfore trial participation.
- Diagnosis of an active additional malignancy (i.e., other than prostate cancer).
- Evidence of biomarker status that would indicate eligibility for treatment other than ARPI, or better prognosis.
- Evidence of prior treatment with therapies that potentially affect study outcomes (e.g., radiopharmaceuticals, taxane, immunotherapy or biological therapy, clinical study drug (CSD), or 177Lu-PSMA-617).
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- Had evidence of inadequate organ function.
- Had evidence of low levels of albumin (< 2.5 g/dL).
- Had evidence of a negative PSMA-PET scan.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Lutetium (177Lu) Vipivotide Tetraxetan Arm of the PSMAfore Clinical Trial to a Switch in Androgen Receptor Pathway Inhibitor (ARPI) as External Control Arm (ECA) Using a Real-world Data Source for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) After Progression on Prior ARPI
The aim of this study is to assess the effectiveness of 177Lu-PSMA-617 (lutetium (177Lu) vipivotide tetraxetan) on survival in patients randomized to receive treatment following progression on one ARPI from the PSMAfore trial compared to the effectiveness of a change in ARPI treatment on survival in a real-world setting in patients with mCRPC who are taxane-naive but have progressed after a switch in ARPI.
- Conditions
- Castration-Resistant Prostatic Cancer
- Keywords
- Metastatic Castration-Resistant Prostate Cancer, External control arm, Real world data
- 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 |
|---|---|---|
| External Control Arm (ECA) | RWD patients with mCRPC who were treated with a change in ARPI after progression on prior ARPI and before taxane treatment. | |
| PSMAfore Trial Treatment Arm (TTA) | PSMAfore trial patients with mCRPC who were treated with 177Lu-PSMA-617 after progression on one ARPI. | |
| PSMAfore Trial Control Arm (TCA) | PSMAfore trial patients with mCRPC who switched to a subsequent ARPI after progression on a prior ARPI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) of the TTA Group
OS defined as time from randomization to death due to any cause.
Measured: Up to approximately 3 years and 6 months
Real-world Overall Survival (rwOS) of the ECA Group (for the Primary Measure)
rwOS is defined as the time from initiation of the index ARPI to death due to any cause.
Measured: Up to approximately 7 years
Secondary outcomes (2)
OS of the TCA Group
Measured: Up to approximately 3 years and 6 months
rwOS of the ECA Group (for the Secondary Measure)
Measured: Up to approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Mar 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-Resistant Prostatic 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
- 1,525 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
- NCT07843758
- Sponsor's protocol ID
- CAAA617A12004
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Lutetium (177Lu) Vipivotide Tetraxetan Arm of the PSMAfore Clinical Trial to a Switch in Androgen Receptor Pathway Inhibitor (ARPI) as External Control Arm (ECA) Using a Real-world Data Source for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) After Progression on Prior ARPI
- ClinicalTrials.gov ID
- NCT07843758
- Acronym / sponsor ID
- CAAA617A12004
- Conditions
- Castration-Resistant Prostatic Cancer
- Keywords
- Metastatic Castration-Resistant Prostate Cancer, External control arm, Real world data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,525 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 28 Sep 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 the effectiveness of 177Lu-PSMA-617 (lutetium (177Lu) vipivotide tetraxetan) on survival in patients randomized to receive treatment following progression on one ARPI from the PSMAfore trial compared to the effectiveness of a change in ARPI treatment on survival in a real-world setting in patients with mCRPC who are taxane-naive but have progressed after a switch in ARPI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| External Control Arm (ECA) | – | –RWD patients with mCRPC who were treated with a change in ARPI after progression on prior ARPI and before taxane treatment. |
| PSMAfore Trial Treatment Arm (TTA) | – | –PSMAfore trial patients with mCRPC who were treated with 177Lu-PSMA-617 after progression on one ARPI. |
| PSMAfore Trial Control Arm (TCA) | – | –PSMAfore trial patients with mCRPC who switched to a subsequent ARPI after progression on a prior ARPI. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PSMAfore trial patients with mCRPC who progressed once after treatment with an ARPI and were taxane-naive, and real-world data (RWD) mCRPC patients from the United States (US)-based health research database who were taxane-naive and had evidence of treatment with a change in ARPI immediately following progression.
Key inclusion criteria (9 listed)
- Had an International Classification of Diseases, 9th or 10th Revision, Clinical Modification (ICD-9-CM or ICD-10-CM) diagnosis of prostate cancer (PC) (ICD-9-CM 185x or ICD-10-CM C61x).
- Had at least two documented clinical visits, on different days, occurring on or after 01 Jan 2013.
- Included in probabilistic sample of patients queued for review via abstraction.
- Had diagnosis of metastatic disease on or after 01 Jan 2013.
- Histology was confirmed as adenocarcinoma of the prostate.
Key exclusion criteria (10 listed)
- Female sex.
- Had evidence of untreated brain metastases.
- Had history of cardiac comorbidities, infection with hepatitis B or C, or spinal cord compression that would indicate significant risk to PSMAfore trial participation.
- Diagnosis of an active additional malignancy (i.e., other than prostate cancer).
- Evidence of biomarker status that would indicate eligibility for treatment other than ARPI, or better prognosis.
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
Overall Survival (OS) of the TTA Group
Time frame: Up to approximately 3 years and 6 months
OS defined as time from randomization to death due to any cause.
Real-world Overall Survival (rwOS) of the ECA Group (for the Primary Measure)
Time frame: Up to approximately 7 years
rwOS is defined as the time from initiation of the index ARPI to death due to any cause.
2 secondary outcomes
OS of the TCA Group
Time frame: Up to approximately 3 years and 6 months
rwOS of the ECA Group (for the Secondary Measure)
Time frame: Up to approximately 7 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 1 Oct 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 Castration-Resistant Prostatic Cancer, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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 9 inclusion and 10 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 1 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 Switzerland. 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?
Overall Survival (OS) of the TTA Group (time frame: Up to approximately 3 years and 6 months). The study lists 2 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 1 Oct 2026.