Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients (ADAPT-P)
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| ClinicalTrials.gov Identifier: NCT06019676 |
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Recruitment Status :
Recruiting
First Posted : August 31, 2023
Last Update Posted : October 12, 2023
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| Tracking Information | |||||||||
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| First Submitted Date | August 17, 2023 | ||||||||
| First Posted Date | August 31, 2023 | ||||||||
| Last Update Posted Date | October 12, 2023 | ||||||||
| Actual Study Start Date | September 26, 2023 | ||||||||
| Estimated Primary Completion Date | April 1, 2027 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Undetectable PSA rate (defined as PSA <0.2ng/ml by end of year 1 and year 2) in mHSPC patients receiving apalutamide [ Time Frame: August 2023 - April 2027 ] | ||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
Health care professional experience on the use of apalutamide, assessed using Health Care Professional Questionnaire [ Time Frame: August 2023 - April 2027 ] | ||||||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients | ||||||||
| Official Title | Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients, a Multicentre Prospective Observational Study | ||||||||
| Brief Summary | The ADAPT study is an observational study of apalutamide, which can be given to patients with hormone sensitive metastatic prostate cancer as standard of care. The clinical decision for patients to have apalutamide as part of their management plan will be decided by the clinician. The patient will only be approached about the ADAPT study if they decide they want to have apalutamide as part of their management. The aims of the ADAPT study include documenting the biochemical effectiveness, as determined by the Prostate-Specific Antigen (PSA) and impact of apaluatmide on health related quality of life. The blood test for PSA is regularly monitored as standard of care. Additionally, the impact of apalutamide on fatigue, cognitive function, patients reported outcomes, health related quality of life will be evaluated using patient questionnaires answered at defined timepoints. The questionnaires will be sent either electronically or via post at week 12, 24, 36, 48, 72 and 104 weeks after commencement of apalutamide. Currently, the majority of data regarding tolerability and biochemical response to apalutamide has been from large phase III trials, where there are strict eligibility criteria. Real-world data as from the ADAPT study can provide valuable complementary data to randomised controlled trials, which can be used to address the 'generalizability' limitations of randomised control trials and can provide evidence on the external validity of their findings. This information can advance knowledge of patterns of care, treatment effectiveness and side-effects and inform clinical practice to improve outcomes. |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Males 18 years of age or older, with metastatic hormone sensitive prostate cancer | ||||||||
| Condition | Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Patients with mHSPC and treatment decision for apalutamide by clinician | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
170 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | April 1, 2027 | ||||||||
| Estimated Primary Completion Date | April 1, 2027 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United Kingdom | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT06019676 | ||||||||
| Other Study ID Numbers | CCR5793 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Royal Marsden NHS Foundation Trust | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Royal Marsden NHS Foundation Trust | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Janssen, LP | ||||||||
| Investigators |
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| PRS Account | Royal Marsden NHS Foundation Trust | ||||||||
| Verification Date | October 2023 | ||||||||