Trial Outcomes & Findings for RElugolix VErsus LeUprolide Cardiac Trial (NCT NCT05320406)

NCT ID: NCT05320406

Last Updated: 2026-02-12

Results Overview

Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

94 participants

Primary outcome timeframe

From baseline to 12 months post-treatment initiation

Results posted on

2026-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Radiation Therapy Alone) Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC	Arm III (Radiation Therapy Plus Relugolix) 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO
Overall Study STARTED	29	34	31
Overall Study COMPLETED	28	28	29
Overall Study NOT COMPLETED	1	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RElugolix VErsus LeUprolide Cardiac Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Radiation Therapy Alone) n=29 Participants Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) n=34 Participants 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC	Arm III (Radiation Therapy Plus Relugolix) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=41 Participants	10 Participants n=1581 Participants	7 Participants n=4626 Participants	27 Participants n=72 Participants
Age, Categorical >=65 years	19 Participants n=41 Participants	24 Participants n=1581 Participants	24 Participants n=4626 Participants	67 Participants n=72 Participants
Age, Continuous	65.79 Years STANDARD_DEVIATION 6.75 • n=41 Participants	68.85 Years STANDARD_DEVIATION 8.12 • n=1581 Participants	68.81 Years STANDARD_DEVIATION 8.83 • n=4626 Participants	67.89 Years STANDARD_DEVIATION 8.02 • n=72 Participants
Sex: Female, Male Female	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Sex: Female, Male Male	29 Participants n=41 Participants	34 Participants n=1581 Participants	31 Participants n=4626 Participants	94 Participants n=72 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants	1 Participants n=1581 Participants	0 Participants n=4626 Participants	1 Participants n=72 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants	0 Participants n=72 Participants
Race (NIH/OMB) Black or African American	6 Participants n=41 Participants	11 Participants n=1581 Participants	7 Participants n=4626 Participants	24 Participants n=72 Participants
Race (NIH/OMB) White	22 Participants n=41 Participants	19 Participants n=1581 Participants	21 Participants n=4626 Participants	62 Participants n=72 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants	1 Participants n=1581 Participants	0 Participants n=4626 Participants	1 Participants n=72 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=41 Participants	2 Participants n=1581 Participants	3 Participants n=4626 Participants	6 Participants n=72 Participants
Region of Enrollment United States	29 participants n=41 Participants	34 participants n=1581 Participants	31 participants n=4626 Participants	94 participants n=72 Participants

PRIMARY outcome

Timeframe: From baseline to 12 months post-treatment initiation

Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.

Outcome measures

Outcome measures
Measure	Arm III (Radiation Therapy Plus Relugolix) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO	Arm I (Radiation Therapy Alone) n=28 Participants Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC
Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) Baseline	272.0 mm3 Interval 65.0 to 766.0	103.0 mm3 Interval 79.0 to 182.0	204.0 mm3 Interval 73.0 to 556.5
Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) Month 12	265.0 mm3 Interval 100.0 to 807.0	130.0 mm3 Interval 55.0 to 265.0	290.0 mm3 Interval 153.0 to 655.5

SECONDARY outcome

Timeframe: From baseline to 12 months post-treatment initiation

Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.

Outcome measures

Outcome measures
Measure	Arm III (Radiation Therapy Plus Relugolix) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO	Arm I (Radiation Therapy Alone) n=28 Participants Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC
Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) Baseline	206.0 mm3 Interval 56.0 to 620.0	98.0 mm3 Interval 74.0 to 167.0	157.0 mm3 Interval 65.5 to 464.5
Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) Month 12	236.0 mm3 Interval 92.0 to 613.0	112.0 mm3 Interval 42.0 to 215.0	252.0 mm3 Interval 133.0 to 511.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to 12 months post-treatment initiation

Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.

Outcome measures

Outcome measures
Measure	Arm III (Radiation Therapy Plus Relugolix) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO	Arm I (Radiation Therapy Alone) n=28 Participants Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC
Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) Baseline	41.0 mm3 Interval 9.0 to 175.0	11.5 mm3 Interval 2.3 to 25.8	34.0 mm3 Interval 5.8 to 98.8
Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) Month 12	46.0 mm3 Interval 16.0 to 185.0	13.0 mm3 Interval 4.0 to 38.8	44.0 mm3 Interval 12.3 to 109.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to 12 months post-treatment initiation

The CACS will be measured by the Agatston score (range 0-400, with higher scores indicating more coronary artery calcium) on precontrast cardiac computed tomography anigiography (CCTA) scans by two blinded, board-certified cardiologists.

Outcome measures

Outcome measures
Measure	Arm III (Radiation Therapy Plus Relugolix) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO	Arm I (Radiation Therapy Alone) n=28 Participants Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC
Coronary Artery Calcium Score (CACS) Baseline	96.0 Agatston score (range 0-400) Interval 14.0 to 390.1	24.9 Agatston score (range 0-400) Interval 5.3 to 91.3	106.6 Agatston score (range 0-400) Interval 4.5 to 249.6
Coronary Artery Calcium Score (CACS) Month 12	109.8 Agatston score (range 0-400) Interval 31.8 to 509.3	36.0 Agatston score (range 0-400) Interval 6.8 to 101.8	102.7 Agatston score (range 0-400) Interval 19.9 to 262.5

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to 12 months post-treatment initiation

Coronary computed tomographic angiography post-contrast images were used for vessel stenosis, using an artificial intelligence-informed coronary stenosis quantification tool (AI-CSQ, Roadmap Analysis, Heart flow, Mountain View CA). Stenoses regions are defined in ranges of 0-29%, 30-49%, 50-69%, and \>70%. The number of participants within each treatment meeting these stenosis thresholds were quantified at baseline and month 12.

Outcome measures

Outcome measures
Measure	Arm III (Radiation Therapy Plus Relugolix) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO	Arm I (Radiation Therapy Alone) n=28 Participants Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 Baseline · <30%	4 Participants	5 Participants	3 Participants
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 Baseline · 30% - 49%	8 Participants	12 Participants	9 Participants
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 Baseline · 50% - 69%	16 Participants	9 Participants	15 Participants
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 Baseline · 70% - 99%	3 Participants	2 Participants	4 Participants
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 Month 12 · <30%	6 Participants	6 Participants	2 Participants
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 Month 12 · 30% - 49%	6 Participants	10 Participants	8 Participants
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 Month 12 · 50% - 69%	15 Participants	10 Participants	17 Participants
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 Month 12 · 70% - 99%	4 Participants	2 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to at least 2 years post-treatment initiation

Incidence of myocardial infarction, need for coronary revascularization, and/or sudden cardiac death will be measured for up to 2 years following enrollment.

Outcome measures

Outcome measures
Measure	Arm III (Radiation Therapy Plus Relugolix) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO	Arm I (Radiation Therapy Alone) n=28 Participants Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC
Major Adverse Cardiovascular Events	0 Participants	1 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and month 0, 3, 6, 12

Change in total testosterone levels (ng/dL) will be measured at baseline and month 0, 3, 6, and 12 between treatment arms. Testosterone change over time will be summarized and plotted over time for each treatment arm.

Outcome measures

Outcome measures
Measure	Arm III (Radiation Therapy Plus Relugolix) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO	Arm I (Radiation Therapy Alone) n=28 Participants Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) n=31 Participants 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC
Testosterone Kinetics 12	199.673 ng/mL Standard Error 16.573	253.631 ng/mL Standard Error 18.149	142.007 ng/mL Standard Error 18.503
Testosterone Kinetics 0	254.548 ng/mL Standard Error 15.828	254.433 ng/mL Standard Error 16.365	292.735 ng/mL Standard Error 15.114
Testosterone Kinetics 3	26.468 ng/mL Standard Error 7.325	266.358 ng/mL Standard Error 16.633	37.483 ng/mL Standard Error 10.254
Testosterone Kinetics 6	25.538 ng/mL Standard Error 5.325	260.606 ng/mL Standard Error 17.815	31.063 ng/mL Standard Error 8.018

Adverse Events

Arm I (Radiation Therapy Alone)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Arm II (Radiation Therapy Plus Leuprolide)

Serious events: 1 serious events

Other events: 27 other events

Deaths: 1 deaths

Arm III (Radiation Therapy Plus Relugolix)

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Radiation Therapy Alone) n=28 participants at risk Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) n=31 participants at risk 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC	Arm III (Radiation Therapy Plus Relugolix) n=31 participants at risk 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO
Infections and infestations sepsis	0.00% 0/28 • 12 months	3.2% 1/31 • Number of events 1 • 12 months	0.00% 0/31 • 12 months

Other adverse events

Other adverse events
Measure	Arm I (Radiation Therapy Alone) n=28 participants at risk Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity. Radiation therapy: Undergo radiation therapy	Arm II (Radiation Therapy Plus Leuprolide) n=31 participants at risk 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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC	Arm III (Radiation Therapy Plus Relugolix) n=31 participants at risk 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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO
Renal and urinary disorders Cystitis noninfective	21.4% 6/28 • Number of events 6 • 12 months	41.9% 13/31 • Number of events 16 • 12 months	38.7% 12/31 • Number of events 14 • 12 months
Gastrointestinal disorders Diarrhea	3.6% 1/28 • Number of events 1 • 12 months	32.3% 10/31 • Number of events 14 • 12 months	45.2% 14/31 • Number of events 24 • 12 months
General disorders Fatigue	32.1% 9/28 • Number of events 13 • 12 months	71.0% 22/31 • Number of events 33 • 12 months	83.9% 26/31 • Number of events 29 • 12 months
Vascular disorders Hot flashes	0.00% 0/28 • 12 months	58.1% 18/31 • Number of events 27 • 12 months	64.5% 20/31 • Number of events 24 • 12 months
Renal and urinary disorders Urinary frequency	42.9% 12/28 • Number of events 14 • 12 months	71.0% 22/31 • Number of events 24 • 12 months	77.4% 24/31 • Number of events 29 • 12 months
Renal and urinary disorders Urinary retention	32.1% 9/28 • Number of events 11 • 12 months	45.2% 14/31 • Number of events 19 • 12 months	19.4% 6/31 • Number of events 6 • 12 months
Renal and urinary disorders Urinary urgency	35.7% 10/28 • Number of events 11 • 12 months	48.4% 15/31 • Number of events 19 • 12 months	61.3% 19/31 • Number of events 20 • 12 months

Additional Information

Dr. Sagar Patel

Emory University

Phone: 404-778-1900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place