The Case of "Triple" Versus "Double" Therapy for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer
Recruiting · NCT06446401 · Observational (researchers observe without assigning treatment) · Lead sponsor: Uppsala University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Lead4Care is an observational, open-label, multicenter study evaluating the effectiveness, tolerance, and cost-effectiveness of triple against double therapy in matched groups of mHSPC patients with high tumor burden. In addition to androgen deprivation therapy (ADT), the triple constitutes of docetaxel and novel hormonal therapy (NHT), and the double of NHT therapy in addition to ADT. Their effectiveness is compared in terms of mortality and morbidity, which is captured by HRQoL, pain, fatigue. Potential side effects are captured by neuropathy, diarrhea, constipation, anxiety, sickness, and dyssomnia. The cost-effectiveness is evaluated within a Markov model from a societal perspective in which the main disease stages are mHSPC, mCRPC and death. In connection with a regular visit in hospital care, prostate cancer patients who in addition to ADT will initiate double or triple therapy are offered participation in the study. If the patient consent on-line, the patient will receive 13 online surveys over a 60-month period. The surveys are sent with an interval of two months for the first six months, quarterly thereafter until two years, and thereafter yearly. Once all participants have been recruited, the baseline data shared by healthcare personnel and patients will be enriched with registry data. This baseline and registry data involves information about the patients' historical and current health- and socioeconomic status. Thereby, Lead4Care will be able to identify comparable groups of patients on triple and double treatments by using advanced matching methods. In order to assure an objective analysis, Lead4Care will not allow any data extraction until Lead4Care has predefined and published all details regarding the comparison. The existing protocol is then complemented with a more detailed description of the comparison groups, the hierarchy of outcomes, and the analysis methods for these outcomes. For these treatments, the main objectives are to: * Compare mortality and morbidity on triple and double therapy, and their relative side-effects. * Capture patient preferences for these different treatment outcomes over time. * Evaluate cost-effectiveness of triple versus double therapy from a societal perspective.
Who can take part
Inclusion criteria
- Patients eligible for inclusion in this study must meet all of the following criteria:
- Patients should have initiated triple or double therapy no longer than 3 months from the start of ADT,
- Patients must have mHSPC at the time of enrolment, and high metastatic burden.
- Patients must be ≥ 18 years old at the time of enrolment. Note: NHT could be abiraterone acetate, apalutamide, darolutamide or enzalutamide.
Exclusion criteria
- Participants meeting any of the of the following criteria are not eligible for inclusion:
- Patients who do not understand written and/or oral instructions in Swedish.
Where it is running
2 locations listed.
- Uppsala University Hospital - Uppsala, Region Uppsala, Sweden
- Uppsala University - Uppsala, Uppsala County, Sweden