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

About This Trial

This study is for adults with advanced prostate cancer that has spread significantly throughout the body but still responds to hormone treatments.
Researchers want to compare two common treatment options—combining standard hormone therapy with either one or two additional cancer medications—to see which approach better controls the disease, causes fewer side effects, and preserves your quality of life.
Because this study only observes your care, it will not change your medications; you and your doctor will choose your treatment plan as normal.
If you take part, your main commitment will be filling out 13 online surveys over five years to share how you are feeling and any symptoms you experience.

More Information

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.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is for adults with advanced prostate cancer that has spread significantly throughout the body but still responds to hormone treatments.

Study Details

Start Date: October 20, 2024
Lead Sponsor: Uppsala University

Full 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: