Metastatic Castration Resistant Prostate Cancer
Conditions
Keywords
Metastatic Castration Resistant Prostate Cancer (mCRPC), lutetium (177Lu) vipivotide tetraxetan
Brief 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. The observation period will be from date of start of treatment up to a maximum of 18 months after end of treatment.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team). 2. ≥ 18 years old at the time of enrollment. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Second Progression-Free Survival (PFS2) | 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 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 |
| Overall Survival (OS) | up to 18 months post-treatment | 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 |
| Prostate-Specific Antigen (PSA) response rates (RR) | up to 18 months post-treatment | PSA response rates (RR): PSA30; PSA50 and PSA90 while patients are on treatment and up to a maximum of 18 months post-treatment |
| Overall Response Rate (ORR) | up to 18 months post treatment | 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. |
| Duration of Response (DoR) | up to 18 months post-treatment | Defined as the onset of the first response to disease progression or death for any reason |
| Proportion of patients with SSE and time to event | up to 18 months post-treatment | Proportion of patients with Symptomatic Skeletal Event (SSE ) and time to event |
| Time to initiation of pain medication | from start of treatment to up to 18 months post-treatment | 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. |
| Change of pain medication | from baseline to up to 18 months post treatment | Change of pain medication (dosage or type of medication) at baseline and during treatment/follow-up. |
| HRQoL - Functional Assessment of Cancer Therapy-Prostate (FACT-P) | from cycle 1 up to 18 months post treatment | 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. |
| HRQoL - Brief Pain Inventory - Short Form (BPI-SF) | from cycle 1 up to 18 months post treatment | 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. |
| HRQoL - Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT) | from cycle 1 up to 18 months post treatment | 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. |
| Correlation between baseline clinical and molecular characteristics and and treatment outcomes | from baseline to up to 18 months post treatment | 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). |
| Number of patients with hospitalized infusion of lutetium (177Lu) vipivotide tetraxetan | 8 months (treatment duration period) | Number of patients with hospitalized infusion of lutetium (177Lu) vipivotide tetraxetan (type of hospitalization and length of stay ). |
| Number of patients with dosimetry performed | 8-9 months (treatment duration period) | Number of patients with dosimetry performed before being discharged after infusion of lutetium (177Lu) vipivotide tetraxetan |
| Number of visits | 9 months (from start of treatment to 30 days FUP period) | 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 |
| Workdays lost | 8-9 months (treatment duration period) | 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. |
Countries
Italy
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed