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The Case of "Triple" Versus "Double" Therapy for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer

Recruitingn/aAges 18 Years - anyMaleUppsala University
NCT06446401 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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.
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What it tests

  • ADT + NHT + Docetaxel
  • ADT + NHT
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Where

2 sites
Uppsala University Hospital
Uppsala, Sweden
Uppsala University
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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