NCT06446401 The Case of "Triple" Versus "Double" Therapy for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer
| NCT ID | NCT06446401 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2024-10-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,400 participants in total. It began in 2024-10-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Sophie Langenskiöld, SRLECT & PhD
PRINCIPAL INVESTIGATOR
Uppsala University
Frequently Asked Questions
Who can join the NCT06446401 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06446401 currently recruiting?
Yes, NCT06446401 is actively recruiting participants. Contact the research team at sophie.langenskiold@medsci.uu.se for enrollment information.
Where is the NCT06446401 trial being conducted?
This trial is being conducted at Uppsala, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT06446401 clinical trial?
NCT06446401 is sponsored by Uppsala University. The principal investigator is Sophie Langenskiöld, SRLECT & PhD at Uppsala University. The trial plans to enroll 1,400 participants.
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