Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650579
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
REVELUTION-2 RelugolixAbiraterone Acetate AA Versus LeuprolideAA Cardiac Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial of Leuprolide Plus Abiraterone Acetate AA Versus Relugolix Plus AA for Advanced Prostate Cancer the REVELUTION-2 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IIIIV trial compares the impact of leuprolide and abiraterone acetate AA versus relugolix and AA on the heart in hormone-naive patients with advanced prostate cancer receiving pelvic radiation therapy Leuprolide is in a class of medications called gonadotropin-releasing hormone agonists GNRHa It prevents the body from making luteinizing hormone-releasing hormone LHRH and luteinizing hormone LH This causes the testicles to stop making testosterone a male hormone in men and may stop the growth of prostate tumor cells that need testosterone to grow Abiraterone acetate an androgen biosynthesis inhibitor works by decreasing the amount of certain hormones in the body Relugolix a GNRH antagonist works by decreasing the amount of testosterone produced by the body This may slow or stop the spread of prostate tumor cells that need testosterone to grow The use of hormone therapy with radiation therapy has been shown to improve survival however studies have suggested that the addition of hormone therapy may worsen heart cardiac disease and high blood pressure In fact studies have shown that the most common cause of death in prostate cancer patients is due to heart disease or heart attacks Computed tomography CT scans create a series of detailed pictures of areas inside the body the pictures are created by a computer linked to an x-ray machine In this study sophisticated cardiac CT images are used to take pictures of patients heart and coronary arteries to help assess damage to the heart Using cardiac CT and blood tests this trial may help doctors determine which patients are at risk of cardiac disease when treated with combination hormone therapy as well as the differential risk of leuprolide versus relugolix in combination with abiraterone acetate
Detailed Description:
PRIMARY OBJECTIVE
I Measure cardiovascular outcomes between combination gonadotropin releasing hormone agonist GNRHa ie leuprolide plus abiraterone acetate AA versus gonadotropin releasing hormone antagonist GNRH-antagonist ie relugolix plus AA in men with advanced prostate cancer receiving definitive radiation therapy
SECONDARY OBJECTIVES
I Identify genomic alterations that predispose an individual to enhanced cardiovascular CV toxicity following hormone therapy with leuprolide or relugolix in combination with abiraterone acetate
II Evaluate serum testosterone kinetics during and after treatment with combination leuprolideAA versus relugolixAA
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive leuprolide intramuscularly IM or subcutaneously SC injection every 3 to 6 months plus oral AA with prednisone daily for up to 24 months in the absence of disease progression or unacceptable toxicity Patients also undergo standard of care radiation therapy Patients may also receive bicalutamide orally PO once daily QD on days 21-30 with first injection of leuprolide at the discretion of the treating provider All patients undergo pre-treatment and 12-month coronary computed tomography angiography CCTA and blood sample collection
ARM II Patients receive oral relugolix PO daily plus oral AA with prednisone daily for up to 24 months in the absence of disease progression or unacceptable toxicity Patients also undergo standard of care radiation therapy All patients undergo pre-treatment and 12-month CCTA and blood sample collection
After completion of study treatment patients are followed up at 30 and 60 days for serum testosterone measurement
I Measure cardiovascular outcomes between combination gonadotropin releasing hormone agonist GNRHa ie leuprolide plus abiraterone acetate AA versus gonadotropin releasing hormone antagonist GNRH-antagonist ie relugolix plus AA in men with advanced prostate cancer receiving definitive radiation therapy
SECONDARY OBJECTIVES
I Identify genomic alterations that predispose an individual to enhanced cardiovascular CV toxicity following hormone therapy with leuprolide or relugolix in combination with abiraterone acetate
II Evaluate serum testosterone kinetics during and after treatment with combination leuprolideAA versus relugolixAA
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive leuprolide intramuscularly IM or subcutaneously SC injection every 3 to 6 months plus oral AA with prednisone daily for up to 24 months in the absence of disease progression or unacceptable toxicity Patients also undergo standard of care radiation therapy Patients may also receive bicalutamide orally PO once daily QD on days 21-30 with first injection of leuprolide at the discretion of the treating provider All patients undergo pre-treatment and 12-month coronary computed tomography angiography CCTA and blood sample collection
ARM II Patients receive oral relugolix PO daily plus oral AA with prednisone daily for up to 24 months in the absence of disease progression or unacceptable toxicity Patients also undergo standard of care radiation therapy All patients undergo pre-treatment and 12-month CCTA and blood sample collection
After completion of study treatment patients are followed up at 30 and 60 days for serum testosterone measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None