Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446401
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
The Case of triple Versus double Therapy for Patients with High Volume Metastatic Hormone Sensitive Prostate Cancer
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lead4Care
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
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 ie 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 ie 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 ie the date and levels for PSAs 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 andor 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 andor 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 eg wwo 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
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 ie 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 ie 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 ie the date and levels for PSAs 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 andor 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 andor 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 eg wwo 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None