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

NCT06517719 | Recruiting

• 1 other identifier: CAAA617A1DE04
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 36

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.

Conditions

Metastatic Castration Resistant Prostate Cancer

Keywords

metastatic castration resistant prostate cancer; mCRPC; Prostate cancer; lutetium vipivotide tetraxetan; 177Lu

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (1)

Lutetium (177Lu) vipivotide tetraxetan

Patients with mCRPC initiating lutetium (177Lu) vipivotide tetraxetan

Other: lutetium (177Lu) vipivotide tetraxetan

Interventions

lutetium (177Lu) vipivotide tetraxetan OTHER

This is an observational study. There is no treatment allocation. The decision to initiate lutetium vipivotide tetraxetan will be based solely on clinical judgement.

Lutetium (177Lu) vipivotide tetraxetan

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Adult male patients with mCRPC
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male patients with mCRPC

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (36)

Novartis Investigative Site

Konstanz, Baden-Wurttemberg, 78464, Germany

RECRUITING

Novartis Investigative Site

Stuttgart, Baden-Wurttemberg, 70174, Germany

RECRUITING

Novartis Investigative Site

Munich, Bavaria, 81377, Germany

RECRUITING

Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

RECRUITING

Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany

RECRUITING

Novartis Investigative Site

Cottbus, Brandenburg, 03048, Germany

RECRUITING

Novartis Investigative Site

Frankfurt (Oder), Brandenburg, 15236, Germany

RECRUITING

Novartis Investigative Site

Ludwigshafen, Germany, 67063, Germany

RECRUITING

Novartis Investigative Site

Marburg, Hesse, 35043, Germany

RECRUITING

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Novartis Investigative Site

Dresden, Saxony, 01307, Germany

RECRUITING

Novartis Investigative Site

Leipzig, Saxony, 04103, Germany

RECRUITING

Novartis Investigative Site

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Novartis Investigative Site

Jena, Thuringia, 07740, Germany

RECRUITING

Novartis Investigative Site

Aachen, 52074, Germany

RECRUITING

Novartis Investigative Site

Augsburg, 86179, Germany

RECRUITING

Novartis Investigative Site

Berlin, 10249, Germany

RECRUITING

Novartis Investigative Site

Berlin, 12559, Germany

RECRUITING

Novartis Investigative Site

Berlin, 13125, Germany

RECRUITING

Novartis Investigative Site

Bielefeld, 33611, Germany

RECRUITING

Novartis Investigative Site

Bonn, 53105, Germany

RECRUITING

Novartis Investigative Site

Chemnitz, 09113, Germany

RECRUITING

Novartis Investigative Site

Dortmund, 44137, Germany

RECRUITING

Novartis Investigative Site

Dortmund, 44309, Germany

RECRUITING

Novartis Investigative Site

Erlangen, 91054, Germany

RECRUITING

Novartis Investigative Site

Essen, 45147, Germany

RECRUITING

Novartis Investigative Site

Fulda, 36043, Germany

RECRUITING

Novartis Investigative Site

Herford, 32049, Germany

RECRUITING

Novartis Investigative Site

Homburg, 66421, Germany

RECRUITING

Novartis Investigative Site

Magdeburg, 39120, Germany

RECRUITING

Novartis Investigative Site

Mainz, 55131, Germany

RECRUITING

Novartis Investigative Site

Nuremberg, 90419, Germany

RECRUITING

Novartis Investigative Site

Rostock, 18057, Germany

RECRUITING

Novartis Investigative Site

Trier, 54290, Germany

RECRUITING

Novartis Investigative Site

Tübingen, 72076, Germany

RECRUITING

Novartis Investigative Site

Ulm, 89081, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lutetium; Lutetium-177

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (36)