Condition: Prostate Cancer · Sponsor: Uppsala University
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 compar…
This description comes directly from the study's public registry record.
Sophie Langenskiöld, SRLECT & PhD · +4673 469 77 64 · sophie.langenskiold@medsci.uu.se
Vincent Nordgren, PhD-student · +4673 469 77 65 · vincent.nordgren@uu.se
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| Uppsala University Hospital | Uppsala, Region Uppsala, Sweden | Not Yet Recruiting |
| Uppsala University | Uppsala, Uppsala County, Sweden | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06446401