Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

Real-world Experience With Lutetium (177Lu) Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer, an Observational, Multicenter, Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Castration Resistant Prostate Cancer
• Intervention / Treatment: Other: lutetium (177Lu) vipivotide tetraxetan

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: Novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • Novartis Investigative Site
  • Augsburg, Germany, 86179
    • Recruiting
    • Novartis Investigative Site
  • Berlin, Germany, 13125
    • Recruiting
    • Novartis Investigative Site
  • Berlin, Germany, 10249
    • Recruiting
    • Novartis Investigative Site
  • Berlin, Germany, 12559
    • Recruiting
    • Novartis Investigative Site
  • Bielefeld, Germany, 33611
    • Recruiting
    • Novartis Investigative Site
  • Bonn, Germany, 53105
    • Recruiting
    • Novartis Investigative Site
  • Chemnitz, Germany, 09113
    • Recruiting
    • Novartis Investigative Site
  • Dortmund, Germany, 44137
    • Recruiting
    • Novartis Investigative Site
  • Dortmund, Germany, 44309
    • Recruiting
    • Novartis Investigative Site
  • Erfurt, Germany, 99089
    • Recruiting
    • Novartis Investigative Site
  • Erlangen, Germany, 91054
    • Recruiting
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Recruiting
    • Novartis Investigative Site
  • Fulda, Germany, 36043
    • Recruiting
    • Novartis Investigative Site
  • Herford, Germany, 32049
    • Recruiting
    • Novartis Investigative Site
  • Homburg, Germany, 66421
    • Recruiting
    • Novartis Investigative Site
  • Magdeburg, Germany, 39120
    • Recruiting
    • Novartis Investigative Site
  • Mainz, Germany, 55131
    • Recruiting
    • Novartis Investigative Site
  • Nuremberg, Germany, 90419
    • Recruiting
    • Novartis Investigative Site
  • Rostock, Germany, 18057
    • Recruiting
    • Novartis Investigative Site
  • Trier, Germany, 54290
    • Recruiting
    • Novartis Investigative Site
  • Tübingen, Germany, 72076
    • Recruiting
    • Novartis Investigative Site
  • Ulm, Germany, 89081
    • Recruiting
    • Novartis Investigative Site
  • Baden-Wurttemberg
    • Konstanz, Baden-Wurttemberg, Germany, 78464
      • Recruiting
      • Novartis Investigative Site
    • Stuttgart, Baden-Wurttemberg, Germany, 70174
      • Recruiting
      • Novartis Investigative Site
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • Novartis Investigative Site
    • Regensburg, Bavaria, Germany, 93053
      • Recruiting
      • Novartis Investigative Site
    • Würzburg, Bavaria, Germany, 97080
      • Recruiting
      • Novartis Investigative Site
  • Brandenburg
    • Cottbus, Brandenburg, Germany, 03048
      • Recruiting
      • Novartis Investigative Site
    • Frankfurt (Oder), Brandenburg, Germany, 15236
      • Recruiting
      • Novartis Investigative Site
  • Germany
    • Ludwigshafen, Germany, Germany, 67063
      • Recruiting
      • Novartis Investigative Site
  • Hesse
    • Marburg, Hesse, Germany, 35043
      • Recruiting
      • Novartis Investigative Site
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Recruiting
      • Novartis Investigative Site
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Novartis Investigative Site
    • Leipzig, Saxony, Germany, 04103
      • Recruiting
      • Novartis Investigative Site
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06120
      • Recruiting
      • Novartis Investigative Site
  • Thuringia
    • Jena, Thuringia, Germany, 07740
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult male patients with mCRPC

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lutetium (177Lu) vipivotide tetraxetan; Patients with mCRPC initiating lutetium (177Lu) vipivotide tetraxetan	Other: lutetium (177Lu) vipivotide tetraxetan; This is an observational study. There is no treatment allocation. The decision to initiate lutetium vipivotide tetraxetan will be based solely on clinical judgement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy - Prostate (FACT-P)	FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.	Baseline, up to 1 year after end of treatment
Change from baseline in FACT-P	FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.	Baseline, up to 1 year after end of treatment
Functional Assessment of Cancer Therapy-Radionuclid Therapy (FACT-RNT)	The FACT-RNT (Functional Assessment of Cancer Therapy - Radionuclide Therapy) is a Patient Reported Outcomes (PRO) new measure developed using FACIT specific questions (items), selected from FACIT item bank, to assess treatment-related symptoms of special interest associated with radioligand therapies. The FACT-RNT contains items assessing dry mouth, dry eyes, vomiting, diarrhea, constipation, loss of appetite, fatigue, impact of fatigue, bone pain, and isolation due to illness or treatment. FACT-RNT score range 0 to 60, with higher score indicating better quality of life.	Baseline, up to 1 year after end of treatment
Change from baseline in FACT-RNT	The FACT-RNT (Functional Assessment of Cancer Therapy - Radionuclide Therapy) is a Patient Reported Outcomes (PRO) new measure developed using FACIT specific questions (items), selected from FACIT item bank, to assess treatment-related symptoms of special interest associated with radioligand therapies. The FACT-RNT contains items assessing dry mouth, dry eyes, vomiting, diarrhea, constipation, loss of appetite, fatigue, impact of fatigue, bone pain, and isolation due to illness or treatment. FACT-RNT score range 0 to 60, with higher score indicating better quality of life.	Baseline, up to 1 year after end of treatment
Brief Pain Inventory-Short Form (BPI-SF)	The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use	Baseline, up to 1 year after end of treatment
Change from baseline in BPI-SF	The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use	Baseline, up to 1 year after end of treatment
Radiographic progression	Radiographic progression is measured with radiographic imaging (e.g. CT with contrast/MRI, bone scan, PET/CT, SPECT/CT) according to RECIST/PCWG3	Up to 1 year after end of treatment
Clinical progression	Unequivocal clinical progression (UCP) is considered a worsening of clinical status with or without radiographic progression (RAD): escalation in cancer related-pain, immediate need for initiation of new anticancer treatment, surgical, or radiological intervention, deterioration in ECOG to grade 3 or higher, in the opinion of investigator	Up to 1 year after end of treatment
Time to prostate-specific antigen (PSA) progression	Time to PSA progression is defined as time from randomization to first PSA progression. PSA progression is defined as the date that a ≥ 25% increase in PSA and an absolute increase of 2 ng/mL or more from the nadir or baseline is documented and confirmed by a second consecutive value obtained 3 or more weeks later. Rises in PSA within the first 12 weeks will be ignored in the absence of other evidence of disease progression (adapted from Prostate Cancer Working Group (PCWG3) Guidance).	Up to 1 year after end of treatment
Prostate-specific antigen (PSA) 30/50/90	Response rates are defined as the proportion of patients who have a ≥30%/50%/90% decrease in PSA from baseline that is confirmed by a second PSA measurement.	Up to 1 year after end of treatment
Progression-free survival (PFS)	PFS, defined as the time from initial treatment to the first documented disease progression or death due to any cause, whichever occurs first.	Up to 1 year after end of treatment
Progression-free survival 2 (PFS2)	PFS2, defined as time from initial treatment to the first documented disease progression or death under the treatment after lutetium (177Lu) vipivotide tetraxetan.	Up to 1 year after end of treatment
Overall Survival (OS)	OS defined as the time from initial treatment until death from any cause.	Up to 1 year after end of treatment
Time to initiation of pain medication	Time to initiation of pain medication is defined as time from index date to the first use of any pain medication or progression.	Up to 1 year after end of treatment

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Prostate cancer; metastatic castration resistant prostate cancer; mCRPC; 177Lu; lutetium vipivotide tetraxetan
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Inorganic Chemicals; Elements; Metals; Transition Elements; Lanthanoid Series Elements; Metals, Rare Earth; Lutetium-177; Lutetium
• Other Study ID Numbers: CAAA617A1DE04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO