Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer
NCT Number: NCT06517719
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Metastatic Castration Resistant Prostate Cancer
Interventions: OTHER: lutetium (177Lu) vipivotide tetraxetan
Sponsor: Novartis Pharmaceuticals
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-31
Completion Date: 2028-02-01

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.

Primary Outcome Measures: 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