Trial Title:
REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
NCT ID:
NCT06650579
Condition:
Recurrent Prostate Carcinoma
Stage III Prostate Cancer AJCC V8
Stage IVA Prostate Cancer AJCC V8
Conditions: Official terms:
Prostatic Neoplasms
Prednisone
Cortisone
Leuprolide
Abiraterone Acetate
Bicalutamide
Relugolix
Conditions: Keywords:
node-positive prostate cancer
advanced prostate cancer
very-high-risk prostate cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
All principal investigators and co-investigators will be blinded to randomization block.
All cardiac computed tomography images will be analyzed by a blinded level 3 boarded
cardiac imaging expert.
Intervention:
Intervention type:
Drug
Intervention name:
Abiraterone Acetate
Description:
Given abiraterone acetate
Arm group label:
Arm I (leuprolide plus abiraterone acetate/prednisone)
Arm group label:
Arm II (relugolix + abiraterone acetate/prednisone)
Other name:
BR9004
Other name:
BR9004-1
Other name:
CB 7630
Other name:
CB-7630
Other name:
CB7630
Other name:
JNJ-212082
Other name:
Yonsa
Other name:
Zytiga
Intervention type:
Drug
Intervention name:
Bicalutamide
Description:
Given PO
Arm group label:
Arm I (leuprolide plus abiraterone acetate/prednisone)
Other name:
Casodex
Other name:
Cassotide
Other name:
Cosudex
Other name:
ICI 176,334
Other name:
ICI 176334
Other name:
Utamide
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm I (leuprolide plus abiraterone acetate/prednisone)
Arm group label:
Arm II (relugolix + abiraterone acetate/prednisone)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography Angiography
Description:
Undergo CCTA
Arm group label:
Arm I (leuprolide plus abiraterone acetate/prednisone)
Arm group label:
Arm II (relugolix + abiraterone acetate/prednisone)
Other name:
CT ANGIOGRAPHY
Other name:
CT Scan Angiography
Other name:
CTA
Intervention type:
Drug
Intervention name:
Leuprolide
Description:
Given IM or SC
Arm group label:
Arm I (leuprolide plus abiraterone acetate/prednisone)
Other name:
Leuprorelin
Intervention type:
Drug
Intervention name:
Prednisone
Description:
Given prednisone
Arm group label:
Arm I (leuprolide plus abiraterone acetate/prednisone)
Arm group label:
Arm II (relugolix + abiraterone acetate/prednisone)
Other name:
.delta.1-Cortisone
Other name:
1, 2-Dehydrocortisone
Other name:
Adasone
Other name:
Cortancyl
Other name:
Dacortin
Other name:
DeCortin
Other name:
Decortisyl
Other name:
Decorton
Other name:
Delta 1-Cortisone
Other name:
Delta-Dome
Other name:
Deltacortene
Other name:
Deltacortisone
Other name:
Deltadehydrocortisone
Other name:
Deltasone
Other name:
Deltison
Other name:
Deltra
Other name:
Econosone
Other name:
Lisacort
Other name:
Meprosona-F
Other name:
Metacortandracin
Other name:
Meticorten
Other name:
Ofisolona
Other name:
Orasone
Other name:
Panafcort
Other name:
Panasol-S
Other name:
Paracort
Other name:
Perrigo Prednisone
Other name:
PRED
Other name:
Predicor
Other name:
Predicorten
Other name:
Prednicen-M
Other name:
Prednicort
Other name:
Prednidib
Other name:
Prednilonga
Other name:
Predniment
Other name:
Prednisone Intensol
Other name:
Prednisonum
Other name:
Prednitone
Other name:
Promifen
Other name:
Rayos
Other name:
Servisone
Other name:
SK-Prednisone
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Undergo standard of care radiation therapy
Arm group label:
Arm I (leuprolide plus abiraterone acetate/prednisone)
Arm group label:
Arm II (relugolix + abiraterone acetate/prednisone)
Other name:
Cancer Radiotherapy
Other name:
Energy Type
Other name:
ENERGY_TYPE
Other name:
Irradiate
Other name:
Irradiated
Other name:
Irradiation
Other name:
Radiation
Other name:
Radiation Therapy, NOS
Other name:
Radiotherapeutics
Other name:
Radiotherapy
Other name:
RT
Other name:
Therapy, Radiation
Intervention type:
Drug
Intervention name:
Relugolix
Description:
Given PO
Arm group label:
Arm II (relugolix + abiraterone acetate/prednisone)
Other name:
N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea
Other name:
Orgovyx
Other name:
Relumina
Other name:
TAK 385
Other name:
TAK-385
Other name:
TAK385
Summary:
This phase III/IV 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, i.e. leuprolide) plus abiraterone acetate (AA) versus gonadotropin
releasing hormone antagonist (GNRH-antagonist, i.e. 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
leuprolide+AA versus relugolix+AA.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Men ≥ 18 years old
- Non-metastatic prostate cancer
- Non-metastatic, biochemically recurrent prostate cancer
- Plan to undergo curative-intent pelvic radiation therapy (photons or protons) with
or without brachytherapy
- Plan to undergo up to 24 months of combination androgen deprivation therapy (ADT)
plus AA and prednisone
Exclusion Criteria:
- Metastatic prostate cancer requiring indefinitive ADT or chemotherapy
- Prior exposure to androgen deprivation therapy
- Prior exposure to chemotherapy, immunotherapy, or radiation therapy
- History of cardiac bypass surgery or percutaneous coronary intervention
- History of cardiac pacemaker or defibrillator
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory Proton Therapy Center
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Contact:
Last name:
Bill Zheng
Phone:
404-686-6856
Email:
bill.zheng@emory.edu
Facility:
Name:
Winship at Emory Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Contact:
Last name:
Bill Zheng
Phone:
404-686-6856
Email:
bill.zheng@emory.edu
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Contact:
Last name:
Sagar A. Patel, MD
Phone:
404-686-4835
Email:
Sagar.patel@emory.edu
Contact backup:
Last name:
Sagar A. Patel
Facility:
Name:
Emory Saint Joseph's Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Contact:
Last name:
Bill Zheng
Phone:
404-686-6856
Email:
bill.zheng@emory.edu
Start date:
December 16, 2024
Completion date:
July 1, 2029
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
Sumitomo Pharma America, Inc.
Agency class:
Industry
Collaborator:
Agency:
National Comprehensive Cancer Network
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06650579
