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Hormone Therapy
Relugolix vs Leuprolide for Prostate Cancer (REVELUTION Trial)
Phase 4
Recruiting
Led By Sagar A Patel, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men >= 18 years old
Plan to undergo curative-intent pelvic radiation therapy with or without ADT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to at least 2 years post-treatment initiation
Awards & highlights
REVELUTION Trial Summary
This trial is investigating the impact of prostate cancer treatment, specifically androgen deprivation therapy (ADT), on the heart and coronary vessels among men with localized, non-metastatic prostate cancer undergoing radiation therapy and concomitant ADT.
Who is the study for?
This trial is for men aged 18 or older with localized, non-metastatic prostate cancer who are planning to receive curative-intent pelvic radiation therapy, with or without androgen deprivation therapy (ADT). Men who have had chemotherapy, immunotherapy, prior ADT, or have metastatic prostate cancer needing more than 24 months of ADT cannot participate.Check my eligibility
What is being tested?
The study compares the effects of two hormone therapies on heart health in men receiving radiation for prostate cancer. Leuprolide, a standard treatment with known cardiac risks is being compared against Relugolix, a newer FDA-approved drug that may be less harmful to the heart.See study design
What are the potential side effects?
Potential side effects include those common to hormone therapies such as hot flashes, fatigue, sexual dysfunction and bone density loss. The trial specifically looks at whether Relugolix has fewer adverse effects on the heart compared to Leuprolide.
REVELUTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 18 or older.
Select...
I am scheduled for radiation therapy aimed at curing my pelvic cancer, with or without hormone therapy.
Select...
My prostate cancer has not spread to other parts of my body.
Select...
My prostate cancer has returned but hasn't spread to other parts.
REVELUTION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to at least 2 years post-treatment initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to at least 2 years post-treatment initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Coronary plaque volume in major coronary arteries (i.e. left anterior descending, left circumflex, right major coronary arteries)
Incidence of high-risk coronary plaque features at month 12 after treatment initiation
Major adverse cardiovascular events
Secondary outcome measures
Acute and late patient-reported morbidity
Testosterone kinetics
Side effects data
From 2013 Phase 3 trial • 397 Patients • NCT0000405478%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Platelet count decreased
1%
Blood albumin decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy
REVELUTION Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (radiation therapy plus relugolix)Experimental Treatment2 Interventions
Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (radiation therapy plus leuprolide)Experimental Treatment2 Interventions
Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Group III: Arm I (radiation therapy alone)Active Control1 Intervention
Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2850
Leuprolide
2008
Completed Phase 4
~18970
Relugolix
2016
Completed Phase 3
~5360
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,552 Total Patients Enrolled
17 Trials studying Prostate Cancer
7,157 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,926,104 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
Sagar A Patel, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man aged 18 or older.I am scheduled for radiation therapy aimed at curing my pelvic cancer, with or without hormone therapy.I have previously received chemotherapy or immunotherapy.My prostate cancer needs hormone therapy for more than 24 months.My prostate cancer has not spread to other parts of my body.I have been treated with hormone therapy for cancer.My prostate cancer has returned but hasn't spread to other parts.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (radiation therapy plus leuprolide)
- Group 2: Arm III (radiation therapy plus relugolix)
- Group 3: Arm I (radiation therapy alone)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate headcount of participants in this experiment?
"Affirmative. According to clinicaltrials.gov, this research study is presently enrolling patients who have been invited since its initial listing on June 6th 2022 and last updated the following day of June 7th 2022. The 90-person trial requires individuals from 4 different sites."
Answered by AI
How does Radiation therapy affect the well-being of patients?
"Radiation therapy has been approved for use, due to the extensive clinical data confirming its safety. As such, it is rated a 3 on our team's scale of 1-3."
Answered by AI
Does this investigation still have opportunities for participation?
"That is correct. The details available on clinicaltrials.gov suggest this medical trial, which was initially listed on June 6th 2022, has commenced recruitment of participants. A total of 90 persons need to be enrolled from 4 different research centres."
Answered by AI
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