Comparing triple therapy to double therapy for high volume metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Uppsala University
  Uppsala, Uppsala County, Sweden Recruiting
• Uppsala University Hospital
  Uppsala, Region Uppsala, Sweden Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.