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Grant: Project Grant

Ottawa Hospital Research Institute

$2,487,015.00

TRIPLE-SWITCH: A Randomized Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors (ARPI) and Androgen Deprivation Treatment (ADT) in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) and Suboptimal PSA Response.

FY 2023-24

Summary
The standard treatment for metastatic prostate cancer is androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI). However, for some patients, their cancer cells do not respond to this treatment. Currently, some cancer doctors recommend adding a chemotherapy called docetaxel to the standard treatment when the cancer has aggressive features indicating that some cells are becoming resistant to the hormone therapy. Other cancer doctors prefer to leave docetaxel treatment until later when the cancer is growing to avoid early side effects. While docetaxel chemotherapy does improve how long patients live on average with metastatic prostate cancer, we are not sure who benefits the most from docetaxel and when it is best to receive it. We believe the best time to offer docetaxel may be about 6-12 months after receiving hormone therapy (ADT + ARPI). We will use a blood test, the prostate-specific antigen (PSA), to gauge how well the cancer is responding to standard treatment. Patients with a PSA 0.2 or less will not be eligible for this trial as they are likely to continue to benefit from hormone therapy for many years. However, patients with a PSA >0.2 after 6 months of hormone treatment will be offered this study because there is a higher chance their cancer will worsen in the next year and, on average, live only 3 years. Eligible patients will be randomly selected to receive either 6 treatments of docetaxel in addition to their hormone therapy or continue their current hormone therapy without docetaxel. The goal of this study is to determine if early treatment with docetaxel extends a patient's life. Other goals include determining if: 1) patients' cancers are sensitive to hormone therapy for longer, 2) patients have good or improved long-term quality of life after docetaxel, and 3) a new blood test (circulating tumour DNA) improves how we decide who benefits the most from docetaxel.
Program
Project Grant
Location
Ontario, Canada
Recipient Type
Other
Type
Grant
Source
CIHR Funding Decisions Database

As published

Id
501409
Name
Ong Michael
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Cancer Research
Theme2
Clinical
Prcname2
Randomized Controlled Trials
Projecttitle
TRIPLE-SWITCH: A Randomized Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors (ARPI) and Androgen Deprivation Treatment (ADT) in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) and Suboptimal PSA Response.
Programtype2
Operating Grants
Orgnameinp2
Ottawa Hospital Research Institute
Cihramount2
$2,487,015
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Androgen Deprivation Treatment (Adt); Androgen Receptor Pathway Inhibitors (Arpi); Circulating Tumour Dna (Ctdna); Docetaxel; International; Metastatic Castration-Sensitive Prostate Cancer; Prostate Specific Antigen (Psa); Randomized Controlled Trial
Abstract
The standard treatment for metastatic prostate cancer is androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI). However, for some patients, their cancer cells do not respond to this treatment. Currently, some cancer doctors recommend adding a chemotherapy called docetaxel to the standard treatment when the cancer has aggressive features indicating that some cells are becoming resistant to the hormone therapy. Other cancer doctors prefer to leave docetaxel treatment until later when the cancer is growing to avoid early side effects. While docetaxel chemotherapy does improve how long patients live on average with metastatic prostate cancer, we are not sure who benefits the most from docetaxel and when it is best to receive it. We believe the best time to offer docetaxel may be about 6-12 months after receiving hormone therapy (ADT + ARPI). We will use a blood test, the prostate-specific antigen (PSA), to gauge how well the cancer is responding to standard treatment. Patients with a PSA 0.2 or less will not be eligible for this trial as they are likely to continue to benefit from hormone therapy for many years. However, patients with a PSA >0.2 after 6 months of hormone treatment will be offered this study because there is a higher chance their cancer will worsen in the next year and, on average, live only 3 years. Eligible patients will be randomly selected to receive either 6 treatments of docetaxel in addition to their hormone therapy or continue their current hormone therapy without docetaxel. The goal of this study is to determine if early treatment with docetaxel extends a patient's life. Other goals include determining if: 1) patients' cancers are sensitive to hormone therapy for longer, 2) patients have good or improved long-term quality of life after docetaxel, and 3) a new blood test (circulating tumour DNA) improves how we decide who benefits the most from docetaxel.
Competitiondate
202403
Approvedterm2
7 yrs 3 mths
Pinamesdelim
Ong, Michael; Jafri, mariam
Approvedterm
7 ans 3 mois
Cihrcontribution2
~ $2,487,015~ $0~
Ottawa Hospital Research Institute - $2,487,015 Grant… | Canada Spends