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

NCT06446401 | Recruiting

• 1 other identifier: 2024-01881-02
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Prostate cancer; mHSPC; Comparative effectiveness evaluation; Triple therapy; Double therapy

Outcome Measures

Primary Outcomes (1)

• Mortality

  Death due to any causes, i.e., overall survival (OS). captured by the Swedish National Cause of Death Register.

  : Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60 and thereafter annually until month 144 (12 years).

Secondary Outcomes (4)

• Fatigue

  Measured at baseline and month 2, 4, 6, 12, 18, 24, 36, 48 and 60.

• Time to progression

  Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48 and 60.

• Time to first line treatment of mCRPC

  Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60 and thereafter annually until month 144 (12 years).

• Pain intensity

  Measured at baseline and month 6, 12, 18, 24, 36, 48, and 60.

Other Outcomes (5)

• Skeleton Related Events (SRE)

  Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60 and thereafter annually until month 144 (12 years).

• General Health-Related Quality of life (HRQoL)

  Measured at baseline and month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48 and 60.

• Side effects

  Measured at baseline and month 2, 4, 6, 9, 12, 15, 18, 21, 24 36, 48 and 60.

Study Arms (2)

Triple therapy

Patients with mHSPC and high tumour burden receiving treatment with androgen deprivation treatment, new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide) and docetaxel.

Drug: ADT + NHT + Docetaxel

Double therapy

Patients with mHSPC and high tumour burden receiving treatment with androgen deprivation treatment and new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide).

Drug: ADT + NHT

Interventions

ADT + NHT + Docetaxel DRUG

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.

Triple therapy

ADT + NHT DRUG

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.

Double therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mHSPC and high tumor burden initiating treatment with triple or double therapy.

You may qualify if:

• 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.

You may not qualify if:

• Patients who do not understand written and/or oral instructions in Swedish.

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator
• University Hospital, Umeå: collaborator
• Sahlgrenska University Hospital: collaborator
• Saint Göran Hospital: collaborator
• Swedish Cancer Society: collaborator
• Uddevalla Hospital: collaborator
• Östersund Hospital: collaborator
• Ryhov County Hospital: collaborator
• Mälarsjukhuset Hospital, Eskilstuna: collaborator
• Västmanlands Hospital, Västerås, Sweden: collaborator
• Gävle Hospital: collaborator

Study Sites (2)

Uppsala University Hospital

Uppsala, Region Uppsala, 751 85, Sweden

NOT YET RECRUITING

Uppsala University

Uppsala, Uppsala County, 753 10, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Sophie Langenskiöld, SRLECT & PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Langenskiöld, SRLECT & PhD

CONTACT

+4673 469 77 64; sophie.langenskiold@medsci.uu.se

Vincent Nordgren, PhD-student

CONTACT

+4673 469 77 65; vincent.nordgren@uu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: October 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

SE (2)