Longitudinal Evaluation of Adding Docetaxel to ADT and Novel Hormone Treatment for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer in Order to Assess Relative Effectiveness: the Case of Triple Versus Double Therapy

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Sweden
Uppsala University
RECRUITING
Uppsala
Uppsala University Hospital
NOT_YET_RECRUITING
Uppsala
Contact Information
Primary
Sophie Langenskiöld, SRLECT & PhD
sophie.langenskiold@medsci.uu.se
+4673 469 77 64
Backup
Vincent Nordgren, PhD-student
vincent.nordgren@uu.se
+4673 469 77 65
Time Frame
Start Date: 2024-10-20
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 1400
Treatments
Triple therapy
Patients with mHSPC and high tumour burden receiving treatment with androgen deprivation treatment, new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide) and docetaxel.
Double therapy
Patients with mHSPC and high tumour burden receiving treatment with androgen deprivation treatment and new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide).
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Umeå, Ryhov County Hospital, Saint Göran Hospital, Västmanlands Hospital, Västerås, Sweden, Uppsala University Hospital, Uddevalla Hospital, Swedish Cancer Society, Östersund Hospital, Sahlgrenska University Hospital, Gävle Hospital, Mälarsjukhuset Hospital, Eskilstuna
Leads: Uppsala University

This content was sourced from clinicaltrials.gov

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