Comparing triple therapy to double therapy for high volume metastatic prostate cancer
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
This study is testing whether a combination of three treatments is better than two for men with advanced prostate cancer to see which option helps them live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Uppsala University Academic / other |
| Locations | 2 sites (Uppsala, Region Uppsala and 1 other locations) |
| Trial ID | NCT06446401 on ClinicalTrials.gov |
What this trial studies
Lead4Care is an observational, open-label, multicenter study that evaluates the effectiveness, tolerance, and cost-effectiveness of triple therapy (androgen deprivation therapy, docetaxel, and novel hormonal therapy) versus double therapy (androgen deprivation therapy and novel hormonal therapy) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC). The study compares these therapies in terms of mortality, morbidity, and side effects, while also assessing cost-effectiveness through a Markov model. Patients will be enrolled based on their treatment choice, and advanced matching methods will be used to ensure comparability between the two therapy groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with high metastatic burden mHSPC who have initiated either triple or double therapy within the last three months.
Not a fit: Patients who do not understand written and/or oral instructions in Swedish may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the most effective treatment options for patients with high volume metastatic hormone-sensitive prostate cancer.
How similar studies have performed: While other studies have evaluated these therapies indirectly, this study aims to provide direct comparative effectiveness data, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Uppsala, Region Uppsala and 1 other locations
- Uppsala University Hospital — Uppsala, Region Uppsala, Sweden (Not_yet_recruiting)
- Uppsala University — Uppsala, Uppsala County, Sweden (Recruiting)
Study contacts
- Principal investigator: Sophie Langenskiöld, SRLECT & PhD — Uppsala University
- Study coordinator: Sophie Langenskiöld, SRLECT & PhD
- Email: sophie.langenskiold@medsci.uu.se
- Phone: +4673 469 77 64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.