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Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients (ADAPT-P)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06019676
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : October 12, 2023
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Study Design
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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients, a Multicentre Prospective Observational Study
Actual Study Start Date : September 26, 2023
Estimated Primary Completion Date : April 1, 2027
Estimated Study Completion Date : April 1, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Apalutamide

Groups and Cohorts
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Group/Cohort
Patients with mHSPC and treatment decision for apalutamide by clinician


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The impact of apalutamide on fatigue, assessed using patient-reported Brief Fatigue Inventory questionnaire [ Time Frame: August 2023 - April 2027 ]
  2. The impact of apalutamide on cognitive function, using patient-reported FACT-Cog questionnaire [ Time Frame: August 2023 - April 2027 ]
  3. The impact of apalutamide on health-related quality of life, using patient-reported EQ-5D-5L questionnaire [ Time Frame: August 2023 - April 2027 ]

Other Outcome Measures:
  1. Health care professional experience on the use of apalutamide, assessed using Health Care Professional Questionnaire [ Time Frame: August 2023 - April 2027 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males 18 years of age or older, with metastatic hormone sensitive prostate cancer
Criteria

Inclusion Criteria:

  • Male 18 years of age or older
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate with both:
  • Metastatic hormone sensitive prostate cancer
  • Treatment decision for apalutamide by clinician

Exclusion Criteria:

  • Non-metastatic prostate cancer
  • Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer
  • Unable to complete patient reported outcome questionnaires
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06019676


Contacts
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Contact: Greta Bucinskaite +442031865157 greta.bucinskaite@rmh.nsh.uk
Contact: Kelly Jones +442031865157 kelly.jones@rmh.nhs.uk

Locations
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United Kingdom
The Royal Marsden Hospital Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Greta Bucinskaite    +442031865157    greta.bucinskaite@rmh.nhs.uk   
Contact: Kelly Jones    +442086613070    kelly.jones@rmh.nhs.uk   
Principal Investigator: Julia Murray, Dr.         
Northern Ireland Cancer Centre, Belfast Health & Social Care Trust Not yet recruiting
Belfast, United Kingdom, BT9 7AB
Contact: Kathy Byrne       kathy.byrne@belfasttrust.hscni.net   
Principal Investigator: Laura Feeney, Dr.         
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Amy Strong    +441223216083    amy.strong2@nhs.net   
Principal Investigator: Danish Mazhar, Dr.         
Velindre Cancer Centre, Velindre University NHS Trust Not yet recruiting
Cardiff, United Kingdom, CF14 2TL
Contact: Amanda Jackson       amanda.jackson2@wales.nhs.uk   
Principal Investigator: Elin S Evans, Dr.         
Clatterbrdige Cancer Centre, NHS Foundation Trust Not yet recruiting
Liverpool, United Kingdom, CH63 4JY
Contact: Kathryn Hughes    +447955689143    ccf-tr.researchteam@nhs.net   
Principal Investigator: Isabel Syndikus, Prof.         
University College London Hospital, NHS Foundation Trust Not yet recruiting
London, United Kingdom, NW1 2PG
Contact: Sophie Short    +447852905911    sophie.short6@nhs.net   
Principal Investigator: Reena Davda, Dr.         
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust Not yet recruiting
Middlesbrough, United Kingdom, TS4 3BW
Contact: Claire Elliott    +4401642835568    claire.elliott4@nhs.net   
Principal Investigator: Darren Leaning, Dr.         
The Rosemere Cancer Centre, Lancashire Teaching Hospitals NHS Foundation Trust Not yet recruiting
Middlesbrough, United Kingdom
Contact: Nina Vekaria    +441772528263    nina.vekaria@lthtr.nhs.uk   
Principal Investigator: Omi Parikh, Dr.         
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust Not yet recruiting
Newcastle, United Kingdom, NE7 7DN
Contact: Stuart Robertson       stuart.robertson@nhs.net   
Principal Investigator: Rachel Pearson, Dr.         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Janssen, LP
Investigators
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Principal Investigator: Julia Murray, Dr. The Royal Marsden Hospital, NHS Foundation Trust
More Information
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT06019676    
Other Study ID Numbers: CCR5793
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: October 12, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Immune System Diseases