Prostate CancerLead4CareNCT06446401
The Case of "Triple" Versus "Double" Therapy for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer
An observational study of Prostate Cancer, run by Uppsala University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ADT + NHT + Docetaxel and ADT + NHT
- How many people
- 1,400 participants
- Where
- 2 sitesSweden
- Study dates
- 20 Oct 2024to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mHSPC and high tumor burden initiating treatment with triple or double therapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Uppsala University Hospital
Uppsala, Region Uppsala, 751 85
Ingrida Verbiené, MD and PhD, +4673 68 69 248, Ingrida.verbiene@akademiska.se
- Recruiting
Uppsala University
Uppsala, Uppsala County, 753 10
Sophie Langenskiöld, PhD & Senior Lecturer, +734697764, sophie.langenskiold@medsci.uu.se
Sophie Langenskiöld, PhD & Senior Lecturer
About this study
Official title: Longitudinal Evaluation of Adding Docetaxel to ADT and Novel Hormone Treatment for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer in Order to Assess Relative Effectiveness: the Case of "Triple" Versus "Double" Therapy
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.
Read more
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.
Read the detailed description
Comprehensive evaluation:
The treatment landscape of metastatic hormone-sensitive prostate cancer (mHSPC) is evolving rapidly and treatment guidelines often need to be made before the effectiveness of available combinations have been compared. Such is the case for the current recommendation to combine androgen deprivation therapy (ADT) with new hormonal therapy (NHT) and docetaxel (DTX). This triple therapy has not yet been directly evaluated against the alternative of ADT and NHT, i.e., the double therapy. The therapies have only been evaluated indirectly in the trials PEACE-1 and ARASENS. Lead4Care will evaluate triple against double therapy with regard to potential differences in disease progression as well as tolerance. Thereby, Lead4Care will do a comprehensive comparative effectiveness (CE) evaluation which can contribute to the pool of evidence important for future guidelines.
Observational design:
Lead4Care leaves the treatment choice to the clinicians and the patients, and uses advanced matching methods to ensure comparability between patients receiving triple- and double therapy. As the groups are expected to differ in terms of their tolerance to DTX, and the doctors valuation of tolerance differ, Lead4Care expect to be able to identify such matching groups on a subset of enrolled patients. The matched groups will be used for the CE evaluation. Patients will consequently be enrolled and followed prospectively irrespective of which therapy the clinicians will choose, and similar groups will be matched especially with regard to their tolerance to DTX as proxied by their age, comorbidity, ECOG collected within Lead4Care but also in terms of their health- and socioeconomic status (SES) in general requested from national registries. The matched groups will be as similar as expected in a randomized experiment in terms of tolerance in particular, but also in terms of health, and SES. Consequently, there is no need for randomization to ensure comparability, using this study design.
Lean observational design:
The additional data that prospective studies usually collect from healthcare, can pose an administrative burden on healthcare workers. Lead4Care has therefore invested considerable effort in developing the study design which leaves few tasks to healthcare workers, i.e., only screen the patient population and report the baseline data. Instead, Lead4Care will take responsibility for all future contact with the patients according to the study protocol. This involves supporting patients in consenting to the study and in reporting their symptoms, tolerance, and progressions in the 13 on-line questionnaires. The patients will hold a patient paper diary with such critical information that the study ask the patients to remember from healthcare visits, i.e., the date and levels for PSA:s, the date for castration resistant, and the date for next treatment. Lead4Care will therefore test a design that minimizes the burden on healthcare systems and which could remove some of the administrative barriers for CE evaluations.
Pain focus:
Recent research suggests that improved pain awareness could potentially reduce the risk of SREs and/or mortality. The rationale behind this is that pain seems to serve as an indicator of development of bone metastasis as the disease advances. Adequate disease management and properly pain control can help mitigate skeleton-related events (SRE), which, in turn, can impact mortality rates. For that reason, Lead4Care will evaluate pain differences across the treatments, and explore how these pain differences potentially can predict SRE and/or mortality.
Cost-effective care:
In Sweden, the cost for prostate cancer consumes a considerable part (12%) of our cancer related healthcare costs, which in in turn constitute 3% of the total healthcare costs. Choosing cost-effective prostate cancer treatments could consequently have a visible impact on Swedish healthcare costs. Lead4Care will therefore evaluate the triple- against the double therapy from a health-economic perspective. The additional cost for adding DTX and treating its potential complications (neurotoxicity, GI side-effects, osteoporosis etc.) will be compared against the difference in quality adjusted life years (QALY). This ratio is used within Sweden for prioritization of scarce resources. Lead4Care can therefore serve as a model for the health-economic (HE) evaluations, which becomes increasingly important as the availability of prostate cancer treatments is increasing.
Patient-centered care:
In healthcare, there is often a dilemma since treatments for prostate cancer can provide survival benefits for the patients but at potential HRQoL loss. For instance, patients who undergo surgery improve their survival but their HRQoL may worsen because of complications. Moreover, patients who receive DTX in the triple therapy may improve their survival but their HRQoL may worsen because of side-effects. Lead4Care has therefore developed an instrument together with patients which captures patients treatment preferences. This instrument will ascertain patients' preferences for life prolonging or HRQoL improving treatments. Lead4Care will therefore help us better understand the populations treatment preferences. This information is important in order to better take the patients preferences into account in planning their care, just as is required in the Swedish Patient Act.
Objectives:
With the implementation of Lead4Care, the hope is to achieve the following objectives:
To evaluate the clinical effectiveness of triple- versus double therapy in matched groups of mHSPC patients with high tumour burden.
To evaluate the tolerance of triple- versus double therapy in matched groups of mHSPC patients with high tumour burden.
To describe the patients treatment preferences (gain in survival against loss of HRQoL) for mHSPC patients with high tumour burden.
To describe the cost-effectiveness of adding DTX for mHSPC-patients with high tumour burden.
To evaluate the clinical effectiveness of triple- versus double therapy in matched sub-groups of mHSPC patients with high tumour burden (e,g, w/wo visceral metastases).
To explore the way pain proxy for or predict SRE and survival for mHSPC-patients with high tumour burden with baseline bone metastases.
- Conditions
- Prostate Cancer
- Being tested
- ADT + NHT + Docetaxel, ADT + NHT
- Keywords
- Prostate cancer, mHSPC, Comparative effectiveness evaluation, Triple therapy, Double therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADT + NHT + DocetaxelDrug
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.
ADT + NHTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: ADT + NHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death due to any causes, i.e., overall survival (OS). captured by the Swedish National Cause of Death Register.
Measured: : 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
Fatigue is a PROM captured by FACIT-F fatigue domain, PGI-C and 3 additional questions related to different aspects of fatigue added by the researchers.
FACIT-F fatigue domain contains 13 questions regarding fatigue. The respondent is asked to report how much the respondent agrees with different statements, measured on a scale between Not at all (0) and Very much (4).
Patient Global Impression of Fatigue Change (PGI-C) is included to understand if the fatigue differences across the treatments are clinically significant. Thereby, the Minimal Important Differences (MIDs) for the different fatigue measurements can be derived. PGI-C is reported on a 7-grade scale, ranging from Very large deterioration (0) to Very large improvement (6).
Other questions:
VAS-scale ranging between No fatigue (0) and Worst possible fatigue (100) Present fatigue, ranging from No fatigue (0) to Excruciating (5). Worst fatigue last 3 weeks, ranging from No fatigue (0) to Excruciating (5)
Measured: Measured at baseline and month 2, 4, 6, 12, 18, 24, 36, 48 and 60.
Time to progression
Time until the patients' prostate cancer becomes castration resistant (mCRPC) is based on patient-reported survey data regarding their progression.
Measured: Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48 and 60.
Time to first line treatment of mCRPC
Time until the patient receives first line treatment for mCRPC is captured by patient reported survey data regarding their start of first line treatment for their mCRPC stage.
Measured: 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
Pain is a PROM captured by The McGill Pain Questionnaire and 3 additional questions related to different aspects of pain added by the researchers.
McGill contains 15 questions regarding type of pain, reported on a 4-grade scale between None (0) and Severe (3). It also contains a VAS-scale ranging between No pain (0) and Worst possible pain (100), as well as a question of present pain intensity, ranging from No pain (0) to Excruciating (5).
Patient Global Impression of Pain Change (PGI-C) has been included to understand if the pain differences across the treatments are clinically significant. Thereby, the Minimal Important Differences (MIDs) for the different pain measurements can be derived. PGI-C is reported on a 7-grade scale, ranging from very large deterioration (0) to very large improvment.
Other questions Yes/No question if the participants experience any pain. 2 questions regarding placement and type of pain.
Measured: Measured at baseline and month 6, 12, 18, 24, 36, 48, and 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start20 Oct 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, University Hospital, Umeå, Sahlgrenska University Hospital, Saint Göran Hospital, Swedish Cancer Society, Uddevalla Hospital, Östersunds Hospital, Ryhov County Hospital, Mälarsjukhuset Hospital, Eskilstuna, Västmanlands Hospital, Västerås, Sweden, Gävle Hospital
- Responsible party
- Sponsor
- Investigators
- Sophie Langenskiöld, SRLECT & PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446401
- Sponsor's protocol ID
- 2024-01881-02
- Acronym
- Lead4Care
- Status last verified
- Oct 2026
- First submitted
- 31 May 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Adding Docetaxel to ADT and Novel Hormone Treatment for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer in Order to Assess Relative Effectiveness: the Case of "Triple" Versus "Double" Therapy
- ClinicalTrials.gov ID
- NCT06446401
- Acronym / sponsor ID
- Lead4Care / 2024-01881-02
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, mHSPC, Comparative effectiveness evaluation, Triple therapy, Double therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, University Hospital, Umeå, Sahlgrenska University Hospital, Saint Göran Hospital, Swedish Cancer Society, Uddevalla Hospital, Östersunds Hospital, Ryhov County Hospital, Mälarsjukhuset Hospital, Eskilstuna, Västmanlands Hospital, Västerås, Sweden, Gävle Hospital
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Comprehensive evaluation:
The treatment landscape of metastatic hormone-sensitive prostate cancer (mHSPC) is evolving rapidly and treatment guidelines often need to be made before the effectiveness of available combinations have been compared. Such is the case for the current recommendation to combine androgen deprivation therapy (ADT) with new hormonal therapy (NHT) and docetaxel (DTX). This triple therapy has not yet been directly evaluated against the alternative of ADT and NHT, i.e., the double therapy. The therapies have only been evaluated indirectly in the trials PEACE-1 and ARASENS. Lead4Care will evaluate triple against double therapy with regard to potential differences in disease progression as well as tolerance. Thereby, Lead4Care will do a comprehensive comparative effectiveness (CE) evaluation which can contribute to the pool of evidence important for future guidelines.
Observational design:
Lead4Care leaves the treatment choice to the clinicians and the patients, and uses advanced matching methods to ensure comparability between patients receiving triple- and double therapy. As the groups are expected to differ in terms of their tolerance to DTX, and the doctors valuation of tolerance differ, Lead4Care expect to be able to identify such matching groups on a subset of enrolled patients. The matched groups will be used for the CE evaluation. Patients will consequently be enrolled and followed prospectively irrespective of which therapy the clinicians will choose, and similar groups will be matched especially with regard to their tolerance to DTX as proxied by their age, comorbidity, ECOG collected within Lead4Care but also in terms of their health- and socioeconomic status (SES) in general requested from national registries. The matched groups will be as similar as expected in a randomized experiment in terms of tolerance in particular, but also in terms of health, and SES. Consequently, there is no need for randomization to ensure comparability, using this study design.
Lean observational design:
The additional data that prospective studies usually collect from healthcare, can pose an administrative burden on healthcare workers. Lead4Care has therefore invested considerable effort in developing the study design which leaves few tasks to healthcare workers, i.e., only screen the patient population and report the baseline data. Instead, Lead4Care will take responsibility for all future contact with the patients according to the study protocol. This involves supporting patients in consenting to the study and in reporting their symptoms, tolerance, and progressions in the 13 on-line questionnaires. The patients will hold a patient paper diary with such critical information that the study ask the patients to remember from healthcare visits, i.e., the date and levels for PSA:s, the date for castration resistant, and the date for next treatment. Lead4Care will therefore test a design that minimizes the burden on healthcare systems and which could remove some of the administrative barriers for CE evaluations.
Pain focus:
Recent research suggests that improved pain awareness could potentially reduce the risk of SREs and/or mortality. The rationale behind this is that pain seems to serve as an indicator of development of bone metastasis as the disease advances. Adequate disease management and properly pain control can help mitigate skeleton-related events (SRE), which, in turn, can impact mortality rates. For that reason, Lead4Care will evaluate pain differences across the treatments, and explore how these pain differences potentially can predict SRE and/or mortality.
Cost-effective care:
In Sweden, the cost for prostate cancer consumes a considerable part (12%) of our cancer related healthcare costs, which in in turn constitute 3% of the total healthcare costs. Choosing cost-effective prostate cancer treatments could consequently have a visible impact on Swedish healthcare costs. Lead4Care will therefore evaluate the triple- against the double therapy from a health-economic perspective. The additional cost for adding DTX and treating its potential complications (neurotoxicity, GI side-effects, osteoporosis etc.) will be compared against the difference in quality adjusted life years (QALY). This ratio is used within Sweden for prioritization of scarce resources. Lead4Care can therefore serve as a model for the health-economic (HE) evaluations, which becomes increasingly important as the availability of prostate cancer treatments is increasing.
Patient-centered care:
In healthcare, there is often a dilemma since treatments for prostate cancer can provide survival benefits for the patients but at potential HRQoL loss. For instance, patients who undergo surgery improve their survival but their HRQoL may worsen because of complications. Moreover, patients who receive DTX in the triple therapy may improve their survival but their HRQoL may worsen because of side-effects. Lead4Care has therefore developed an instrument together with patients which captures patients treatment preferences. This instrument will ascertain patients' preferences for life prolonging or HRQoL improving treatments. Lead4Care will therefore help us better understand the populations treatment preferences. This information is important in order to better take the patients preferences into account in planning their care, just as is required in the Swedish Patient Act.
Objectives:
With the implementation of Lead4Care, the hope is to achieve the following objectives:
To evaluate the clinical effectiveness of triple- versus double therapy in matched groups of mHSPC patients with high tumour burden.
To evaluate the tolerance of triple- versus double therapy in matched groups of mHSPC patients with high tumour burden.
To describe the patients treatment preferences (gain in survival against loss of HRQoL) for mHSPC patients with high tumour burden.
To describe the cost-effectiveness of adding DTX for mHSPC-patients with high tumour burden.
To evaluate the clinical effectiveness of triple- versus double therapy in matched sub-groups of mHSPC patients with high tumour burden (e,g, w/wo visceral metastases).
To explore the way pain proxy for or predict SRE and survival for mHSPC-patients with high tumour burden with baseline bone metastases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple therapy | – | Drug: ADT + NHT + DocetaxelPatients with mHSPC and high tumour burden receiving treatment with androgen deprivation treatment, new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide) and docetaxel. |
| Double therapy | – | Drug: ADT + NHTPatients with mHSPC and high tumour burden receiving treatment with androgen deprivation treatment and new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mHSPC and high tumor burden initiating treatment with triple or double therapy.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who do not understand written and/or oral instructions in Swedish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADT + NHT + DocetaxelLead4Care 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 | Triple therapy |
| ADT + NHTLead4Care 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. | Drug | Double therapy |
Primary outcome
Mortality
Time frame: : Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60 and thereafter annually until month 144 (12 years).
Death due to any causes, i.e., overall survival (OS). captured by the Swedish National Cause of Death Register.
4 secondary outcomes
Fatigue
Time frame: Measured at baseline and month 2, 4, 6, 12, 18, 24, 36, 48 and 60.
Time to progression
Time frame: Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48 and 60.
Time to first line treatment of mCRPC
Time frame: 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
Time frame: Measured at baseline and month 6, 12, 18, 24, 36, 48, and 60.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Langenskiöld, SRLECT & PhD principal investigator
Uppsala University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Uppsala University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Langenskiöld, SRLECT & PhD (+4673 469 77 64, sophie.langenskiold@medsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: : Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60 and thereafter annually until month 144 (12 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.