Metastatic Castration Resistant Prostate CancerNCT07093801
Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer
An observational study of Metastatic Castration Resistant Prostate Cancer, run by Novartis Pharmaceuticals at 35 sites in Italy.
Trial summary
This is a local prospective, multicenter, long-term, non-interventional study using primary data collection to describe the routine clinical practice of patients with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- How many people
- 300 participants
- Where
- 35 sitesItaly
- Study dates
- 30 Jul 2025to 30 Mar 2029
- 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 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan
- Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team).
- ≥ 18 years old at the time of enrollment.
- Written informed consent must be obtained to participate to this study
In addition to the above-listed criteria, no other inclusion/exclusion criteria exist other than the requirements stated in the local Summary of Product Characteristics (SmPC) and in the "Scheda di Monitoraggio AIFA", e.g., contraindications.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Italy35 sites
Novartis Investigative Site
Alessandria, AL, 15121
Novartis Investigative Site
Asti, AT, 14100
Novartis Investigative Site
Avellino, AV, 83100
Novartis Investigative Site
Aviano, PN, 33081
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Cagliari, CA, 09121
Novartis Investigative Site
Cona, FE, 44124
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Foggia, FG, 71122
Novartis Investigative Site
Genova, GE, 16128
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
La Spezia, SP, 19121
Novartis Investigative Site
Latina, LT, 04100
Novartis Investigative Site
Meldola, FC, 47014
Novartis Investigative Site
Mestre, VE, 30174
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Misterbianco, CT, 95045
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Negrar, VR, 37024
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Palermo, PA, 90146
Novartis Investigative Site
Perugia, PG, 06129
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
Province of Macerata, MC, 62100
Novartis Investigative Site
Reggio Emilia, RE, 42123
Novartis Investigative Site
Rionero in Vulture, PZ, 85028
Novartis Investigative Site
Roma, RM, 00128
Novartis Investigative Site
Roma, RM, 00152
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Roma, RM, 00189
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Torino, TO, 10128
About this study
Official title: Real-world Experience of Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, National, Multicenter, Prospective Cohort Study (PLU4REAL).
This is a local prospective, multicenter, long-term, non-interventional study using primary data collection to describe the routine clinical practice of patients with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan. The observation period will be from date of start of treatment up to a maximum of 18 months after end of treatment.
- Keywords
- Metastatic Castration Resistant Prostate Cancer (mCRPC), lutetium (177Lu) vipivotide tetraxetan
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 |
|---|---|---|
| Patients diagnosed with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan | Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Defined as the time from date of initiation of lutetium (177Lu) vipivotide tetraxetan to the date of first documented progression by investigator assessment (radiographic progression according to the most recent version of Prostate Cancer Working Group [PCWG] or Response Evaluation Criteria In PSMA-PET/CT [RECIP] 1.0, clinical progression, Prostate Specific Antigen [PSA] progression) or death from any cause, whichever occurs first up to 18 months post-treatment.
Measured: up to 18 months post-treatment
Secondary outcomes (16)
Second Progression-Free Survival (PFS2)
Defined as the time from date of initiation of lutetium (177Lu) vipivotide tetraxetan to the date of first documented progression by investigator assessment (radiographic progression according to the most recent version of PCWG or RECIP 1.0, clinical progression, PSA progression) on next-line therapy or death from any cause, whichever occurs first, up to 18 months post-treatment
Measured: up to 18 months post-treatment
Overall Survival (OS)
Defined as the time from of initiation of lutetium (177Lu) vipivotide tetraxetan until death from any cause at each cycle of lutetium (177Lu) vipivotide tetraxetan up to 18 months post-treatment
Measured: up to 18 months post-treatment
Prostate-Specific Antigen (PSA) response rates (RR)
PSA response rates (RR): PSA30; PSA50 and PSA90 while patients are on treatment and up to a maximum of 18 months post-treatment
Measured: up to 18 months post-treatment
Overall Response Rate (ORR)
Defined as the proportion of patients with Complete Response (CR) or Partial Response (PR) as Best Overall Response based on RECIST 1.1 or RECIP 1.0.
Measured: up to 18 months post treatment
Duration of Response (DoR)
Defined as the onset of the first response to disease progression or death for any reason
Measured: up to 18 months post-treatment
Proportion of patients with SSE and time to event
Proportion of patients with Symptomatic Skeletal Event (SSE ) and time to event
Measured: up to 18 months post-treatment
Time to initiation of pain medication
Time to initiation of pain medication (if not on pain medication at baseline), assessed as time from index date (start of treatment) to date of initiation of pain medication while on treatment or at progression.
Measured: from start of treatment to up to 18 months post-treatment
Change of pain medication
Change of pain medication (dosage or type of medication) at baseline and during treatment/follow-up.
Measured: from baseline to up to 18 months post treatment
HRQoL - Functional Assessment of Cancer Therapy-Prostate (FACT-P)
The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire is a relevant, worldwide tool used for providing insights into both general and prostate-specific concerns in men with prostate cancer.
The FACT-P is composed of two parts, the FACT-G and the 12-item Prostate Cancer Subscale (PCS). FACT-P total score will be derived as sum of the PWB score, SWB score, EWB score FWB and PCS score and it will range from 0 to 156. Higher scores indicate better health-related quality of life.
Measured: from cycle 1 up to 18 months post treatment
HRQoL - Brief Pain Inventory - Short Form (BPI-SF)
The Brief Pain Inventory - Short Form (BPI-SF) is a widely used tool for assessing clinical pain. The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function.
Score ranges from 0 to 10. Higher score indicate worse outcomes.
Measured: from cycle 1 up to 18 months post treatment
HRQoL - Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT)
The Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT) is used to assess health-related quality of life (HRQoL) in patients undergoing radionuclide therapy for prostate cancer, addressing general concerns and therapy-specific impacts.
Score ranges from 0 to 60. The higher the score the better the quality of life.
Measured: from cycle 1 up to 18 months post treatment
Correlation between baseline clinical and molecular characteristics and and treatment outcomes
Correlative analysis between baseline clinical and molecular characteristics (PSA, BRCA 1/2, PET PSMA quantitative analysis and Androgen Receptor [AR] expression) and treatment outcomes (PFS, PFS2, PSA RR, OS, ORR, DOR).
Measured: from baseline to up to 18 months post treatment
Number of patients with hospitalized infusion of lutetium (177Lu) vipivotide tetraxetan
Number of patients with hospitalized infusion of lutetium (177Lu) vipivotide tetraxetan (type of hospitalization and length of stay ).
Measured: 8 months (treatment duration period)
Number of patients with dosimetry performed
Number of patients with dosimetry performed before being discharged after infusion of lutetium (177Lu) vipivotide tetraxetan
Measured: 8-9 months (treatment duration period)
Number of visits
Number of hospitalizations, emergency room visits, and hospital-based outpatient visits between Cycle 1 and the 30-day follow-up period after the last cycle, due to both adverse events (AE) (related or not to the treatment) and events not related to AE
Measured: 9 months (from start of treatment to 30 days FUP period)
Workdays lost
Number of workdays lost due to hospitalization for infusion of lutetium (177Lu) vipivotide tetraxetan and number of workdays lost due to hospitalization due to treatment-related AE.
Measured: 8-9 months (treatment duration period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start30 Jul 2025
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant 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
- Prospective
- Enrolment
- 300 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
- NCT07093801
- Sponsor's protocol ID
- CAAA617A1IT01
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Experience of Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, National, Multicenter, Prospective Cohort Study (PLU4REAL).
- ClinicalTrials.gov ID
- NCT07093801
- Acronym / sponsor ID
- CAAA617A1IT01
- Keywords
- Metastatic Castration Resistant Prostate Cancer (mCRPC), lutetium (177Lu) vipivotide tetraxetan
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 30 Jul 2025 (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.
This is a local prospective, multicenter, long-term, non-interventional study using primary data collection to describe the routine clinical practice of patients with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan. The observation period will be from date of start of treatment up to a maximum of 18 months after end of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan | – | –Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan
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
Progression-Free Survival (PFS)
Time frame: up to 18 months post-treatment
Defined as the time from date of initiation of lutetium (177Lu) vipivotide tetraxetan to the date of first documented progression by investigator assessment (radiographic progression according to the most recent version of Prostate Cancer Working Group [PCWG] or Response Evaluation Criteria In PSMA-PET/CT [RECIP] 1.0, clinical progression, Prostate Specific Antigen [PSA] progression) or death from any cause, whichever occurs first up to 18 months post-treatment.
16 secondary outcomes
Second Progression-Free Survival (PFS2)
Time frame: up to 18 months post-treatment
Overall Survival (OS)
Time frame: up to 18 months post-treatment
Prostate-Specific Antigen (PSA) response rates (RR)
Time frame: up to 18 months post-treatment
Overall Response Rate (ORR)
Time frame: up to 18 months post treatment
Duration of Response (DoR)
Time frame: up to 18 months post-treatment
Proportion of patients with SSE and time to event
Time frame: up to 18 months post-treatment
Time to initiation of pain medication
Time frame: from start of treatment to up to 18 months post-treatment
Change of pain medication
Time frame: from baseline to up to 18 months post treatment
HRQoL - Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time frame: from cycle 1 up to 18 months post treatment
HRQoL - Brief Pain Inventory - Short Form (BPI-SF)
Time frame: from cycle 1 up to 18 months post treatment
HRQoL - Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT)
Time frame: from cycle 1 up to 18 months post treatment
Correlation between baseline clinical and molecular characteristics and and treatment outcomes
Time frame: from baseline to up to 18 months post treatment
Number of patients with hospitalized infusion of lutetium (177Lu) vipivotide tetraxetan
Time frame: 8 months (treatment duration period)
Number of patients with dosimetry performed
Time frame: 8-9 months (treatment duration period)
Number of visits
Time frame: 9 months (from start of treatment to 30 days FUP period)
Workdays lost
Time frame: 8-9 months (treatment duration period)
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 29 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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration Resistant Prostate Cancer, run by Novartis Pharmaceuticals at 35 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 29 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 35 sites in Italy. 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?
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?
Progression-Free Survival (PFS) (time frame: up to 18 months post-treatment). 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 29 Oct 2026.