Clinical trial NCT06517719: Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer
Official title: Real-world Experience With Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, Multicenter, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Castration Resistant Prostate Cancer
Keywords: metastatic castration resistant prostate cancer
mCRPC
Prostate cancer
lutetium vipivotide tetraxetan
177Lu
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male patients with mCRPC

Brief summary: The purpose of this study is to describe routine clinical practice with lutetium (177Lu) vipivotide tetraxetan on Health related quality of life (HRQoL) at baseline, on treatment, and post progression.

Detailed description: This non-interventional observational, prospective cohort study is using primary data collection to describe the routine clinical practice and HRQoL of patients with Metastatic castration-resistant prostate cancer (mCRPC) initiating lutetium (177Lu) vipivotide tetraxetan using patient questionnaires.

Data will be collected at the following time points: pre-index (if patient is eligible), index date (first application of lutetium (177Lu) vipivotide tetraxetan), during treatment, at EoT, and during follow-up.

The duration of a treatment cycle is 6 weeks (± 1 week). Patients will be treated for up to 6 cycles (as per local label).

EoT visit / assessments will be performed after the last lutetium (177Lu) vipivotide tetraxetan application.

Follow-up period: patient data will be collected if available up to 1 year after EoT.

Eligibility criteria: Inclusion Criteria:

All patients must meet the following inclusion criteria during the identification period:

* Adult male patients diagnosed with mCRPC and initiating lutetium (177Lu) vipivotide tetraxetan by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of Cycle 1.
* ≥ 18 years old at the time of enrollment
* Written informed consent must be obtained prior to any data collection
* Willing to participate in Quality of Life post treatment date collection for 1 year

Exclusion Criteria:

Patients must not meet the following exclusion criterion during the identification period:

- Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - Prostate (FACT-P)
timeFrame: Baseline, up to 1 year after end of treatment
measure: Change from baseline in FACT-P
timeFrame: Baseline, up to 1 year after end of treatment
measure: Functional Assessment of Cancer Therapy-Radionuclid Therapy (FACT-RNT)
timeFrame: Baseline, up to 1 year after end of treatment
measure: Change from baseline in FACT-RNT
timeFrame: Baseline, up to 1 year after end of treatment
measure: Brief Pain Inventory-Short Form (BPI-SF)
timeFrame: Baseline, up to 1 year after end of treatment
measure: Change from baseline in BPI-SF
timeFrame: Baseline, up to 1 year after end of treatment
measure: Radiographic progression
timeFrame: Up to 1 year after end of treatment
measure: Clinical progression
timeFrame: Up to 1 year after end of treatment
measure: Time to prostate-specific antigen (PSA) progression
timeFrame: Up to 1 year after end of treatment
measure: Prostate-specific antigen (PSA) 30/50/90
timeFrame: Up to 1 year after end of treatment
measure: Progression-free survival (PFS)
timeFrame: Up to 1 year after end of treatment
measure: Progression-free survival 2 (PFS2)
timeFrame: Up to 1 year after end of treatment
measure: Overall Survival (OS)
timeFrame: Up to 1 year after end of treatment
measure: Time to initiation of pain medication
timeFrame: Up to 1 year after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Regensburg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Halle S
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: