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

Summary

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.

Conditions

• Prostate Cancer

Interventions

DRUG

ADT + NHT + Docetaxel

Lead4Care leaves the treatment choice to the clinicians and the patients, i.e., does not intervene in their choice of treatment. However, Lead4Care proxy a randomized controlled experiment in which the intervention would be to add docetaxel to androgen deprivation treatment, new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide). This involves a comparison of triple and double therapies. This group recives the triple therapy, i.e. ADT, NHT and Docetaxel.

DRUG

ADT + NHT

Lead4Care leaves the treatment choice to the clinicians and the patients, i.e., does not intervene in their choice of treatment. However, Lead4Care proxy a randomized controlled experiment in which the intervention would be to add docetaxel to androgen deprivation treatment, new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide). This involves a comparison of triple and double therapies. This group recives double therapy, i.e. they are receiving NHT and ADT, but not Docetaxel.

Sponsors & Collaborators

• Uppsala University Hospital

  collaborator OTHER

• University Hospital, Umeå

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Saint Göran Hospital

  collaborator UNKNOWN

• Swedish Cancer Society

  collaborator OTHER

• Uddevalla Hospital

  collaborator UNKNOWN

• Östersund Hospital

  collaborator UNKNOWN

• Ryhov County Hospital

  collaborator OTHER

• Mälarsjukhuset Hospital, Eskilstuna

  collaborator UNKNOWN

• Västmanlands Hospital, Västerås, Sweden

  collaborator UNKNOWN

• Gävle Hospital

  collaborator OTHER

• Uppsala University

  lead OTHER

Principal Investigators

• Sophie Langenskiöld, SRLECT & PhD · Uppsala University

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-20

Primary Completion

2026-12-31

Completion

2031-12-31

Countries

• Sweden

Study Locations