Biochemically Recurrent Prostate Carcinoma, Localized Prostate Carcinoma, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8
Conditions
Brief summary
This clinical trial investigates 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 definitive radiation therapy and concomitant ADT. Recently, cardiovascular toxicity from hormone therapy that is routinely used for prostate cancer (e.g. leuprolide) has emerged as a concern, yet studies identifying who is at risk and the mechanism of cardiac damage are lacking. Additionally, a new hormone therapy drug, relugolix, has recently been Food and Drug Administration (FDA)-approved and may reduce toxicity to the heart. This trial intends to investigate the mechanism of cardiovascular toxicity from ADT, investigate the mechanism by which relugolix reduces cardiovascular toxicity, and identify predictive biomarkers to improve individualized risk-assessment for cardiovascular toxicity from ADT.
Detailed description
PRIMARY OBJECTIVES: I. Identify and compare the association of gonadotrophin releasing hormone (GNRH)-agonist leuprolide versus GNRH-antagonist relugolix with coronary atherosclerosis and progression in men with prostate cancer. II. Determine the relationship between leuprolide versus relugolix with downstream immune effector response that is implicated in atherosclerosis. II. Determine how pre-existing genomic alterations associated with proinflammatory immunity impact development of CV toxicity following GNRH-agonist (GNRHa) versus relugolix. III. Identify imaging biomarkers associated with increased risk of CV toxicity from ADT OUTLINE: Patients undergoing radiation therapy alone as part of their standard treatment are assigned to Arm I. Patients undergoing radiation therapy and ADT as part of their standard treatment are randomized to Arm II or Arm III. ARM I: Patients undergo definitive radiation therapy in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo radiation therapy as in Arm I and receive leuprolide subcutaneously (SC) or intramuscularly (IM) every 3 or 6 months. Treatment continues for 6 to 24 months (depending on cancer risk) in the absence of disease progression or unacceptable toxicity. ARM III: Patients undergo radiation therapy as in Arm I and receive relugolix orally (PO) once daily (QD) for 6 to 24 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
Interventions
RADIATIONRadiation therapy
Undergo radiation therapy
DRUGLeuprolide
Given IM or SC
DRUGRelugolix
Given PO
Sponsors
Emory University
National Cancer Institute (NCI)
Prostate Cancer Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men \>= 18 years old * Non-metastatic prostate cancer * Non-metastatic, biochemically recurrent prostate cancer * Plan to undergo curative-intent pelvic radiation therapy with or without ADT
Exclusion criteria
* Metastatic prostate cancer requiring \> 24 months of ADT * Prior exposure to androgen deprivation therapy * Prior exposure to chemotherapy or immunotherapy * History of cardiac bypass surgery or percutaneous coronary intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSagar A Patel, MD
Emory University Hospital/Winship Cancer Institute
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 29 |
| 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 | 34 |
| 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 | 31 |
| Total | 94 |
Baseline characteristics
| Characteristic | Arm II (Radiation Therapy Plus Leuprolide) | Arm III (Radiation Therapy Plus Relugolix) | Total | Arm I (Radiation Therapy Alone) |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 24 Participants | 67 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 7 Participants | 27 Participants | 10 Participants |
| Age, Continuous | 68.85 Years STANDARD_DEVIATION 8.12 | 68.81 Years STANDARD_DEVIATION 8.83 | 67.89 Years STANDARD_DEVIATION 8.02 | 65.79 Years STANDARD_DEVIATION 6.75 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 7 Participants | 24 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 21 Participants | 62 Participants | 22 Participants |
| Region of Enrollment United States | 34 participants | 31 participants | 94 participants | 29 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 34 Participants | 31 Participants | 94 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 1 / 31 | 0 / 31 |
| other Total, other adverse events | 23 / 28 | 27 / 31 | 30 / 31 |
| serious Total, serious adverse events | 0 / 28 | 1 / 31 | 0 / 31 |
Outcome results
Primary
Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)
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.
Time frame: From baseline to 12 months post-treatment initiation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm I (Radiation Therapy Alone) | Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Baseline | 103.0 mm3 |
| Arm I (Radiation Therapy Alone) | Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Month 12 | 130.0 mm3 |
| Arm II (Radiation Therapy Plus Leuprolide) | Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Baseline | 204.0 mm3 |
| Arm II (Radiation Therapy Plus Leuprolide) | Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Month 12 | 290.0 mm3 |
| Arm III (Radiation Therapy Plus Relugolix) | Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Baseline | 272.0 mm3 |
| Arm III (Radiation Therapy Plus Relugolix) | Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Month 12 | 265.0 mm3 |
Secondary
Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)
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.
Time frame: From baseline to 12 months post-treatment initiation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm I (Radiation Therapy Alone) | Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Baseline | 98.0 mm3 |
| Arm I (Radiation Therapy Alone) | Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Month 12 | 112.0 mm3 |
| Arm II (Radiation Therapy Plus Leuprolide) | Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Baseline | 157.0 mm3 |
| Arm II (Radiation Therapy Plus Leuprolide) | Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Month 12 | 252.0 mm3 |
| Arm III (Radiation Therapy Plus Relugolix) | Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Baseline | 206.0 mm3 |
| Arm III (Radiation Therapy Plus Relugolix) | 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 |
Other Pre-specified
Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)
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.
Time frame: From baseline to 12 months post-treatment initiation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm I (Radiation Therapy Alone) | Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Baseline | 11.5 mm3 |
| Arm I (Radiation Therapy Alone) | Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Month 12 | 13.0 mm3 |
| Arm II (Radiation Therapy Plus Leuprolide) | Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Baseline | 34.0 mm3 |
| Arm II (Radiation Therapy Plus Leuprolide) | Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) | Month 12 | 44.0 mm3 |
| Arm III (Radiation Therapy Plus Relugolix) | 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 |
| Arm III (Radiation Therapy Plus Relugolix) | 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 |
Other Pre-specified
Coronary Artery Calcium Score (CACS)
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.
Time frame: From baseline to 12 months post-treatment initiation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm I (Radiation Therapy Alone) | Coronary Artery Calcium Score (CACS) | Baseline | 24.9 Agatston score (range 0-400) |
| Arm I (Radiation Therapy Alone) | Coronary Artery Calcium Score (CACS) | Month 12 | 36.0 Agatston score (range 0-400) |
| Arm II (Radiation Therapy Plus Leuprolide) | Coronary Artery Calcium Score (CACS) | Baseline | 106.6 Agatston score (range 0-400) |
| Arm II (Radiation Therapy Plus Leuprolide) | Coronary Artery Calcium Score (CACS) | Month 12 | 102.7 Agatston score (range 0-400) |
| Arm III (Radiation Therapy Plus Relugolix) | Coronary Artery Calcium Score (CACS) | Month 12 | 109.8 Agatston score (range 0-400) |
| Arm III (Radiation Therapy Plus Relugolix) | Coronary Artery Calcium Score (CACS) | Baseline | 96.0 Agatston score (range 0-400) |
Other Pre-specified
Major Adverse Cardiovascular Events
Incidence of myocardial infarction, need for coronary revascularization, and/or sudden cardiac death will be measured for up to 2 years following enrollment.
Time frame: From baseline to at least 2 years post-treatment initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (Radiation Therapy Alone) | Major Adverse Cardiovascular Events | 1 Participants |
| Arm II (Radiation Therapy Plus Leuprolide) | Major Adverse Cardiovascular Events | 3 Participants |
| Arm III (Radiation Therapy Plus Relugolix) | Major Adverse Cardiovascular Events | 0 Participants |
Other Pre-specified
Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12
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.
Time frame: From baseline to 12 months post-treatment initiation
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm I (Radiation Therapy Alone) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Baseline | <30% | 5 Participants |
| Arm I (Radiation Therapy Alone) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Baseline | 30% - 49% | 12 Participants |
| Arm I (Radiation Therapy Alone) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Baseline | 50% - 69% | 9 Participants |
| Arm I (Radiation Therapy Alone) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Baseline | 70% - 99% | 2 Participants |
| Arm I (Radiation Therapy Alone) | 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 |
| Arm I (Radiation Therapy Alone) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Month 12 | 30% - 49% | 10 Participants |
| Arm I (Radiation Therapy Alone) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Month 12 | 50% - 69% | 10 Participants |
| Arm I (Radiation Therapy Alone) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Month 12 | 70% - 99% | 2 Participants |
| Arm II (Radiation Therapy Plus Leuprolide) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Baseline | 50% - 69% | 15 Participants |
| Arm II (Radiation Therapy Plus Leuprolide) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Month 12 | 50% - 69% | 17 Participants |
| Arm II (Radiation Therapy Plus Leuprolide) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Baseline | 70% - 99% | 4 Participants |
| Arm II (Radiation Therapy Plus Leuprolide) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Month 12 | <30% | 2 Participants |
| Arm II (Radiation Therapy Plus Leuprolide) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Month 12 | 30% - 49% | 8 Participants |
| Arm II (Radiation Therapy Plus Leuprolide) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Baseline | <30% | 3 Participants |
| Arm II (Radiation Therapy Plus Leuprolide) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Baseline | 30% - 49% | 9 Participants |
| Arm II (Radiation Therapy Plus Leuprolide) | 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 |
| Arm III (Radiation Therapy Plus Relugolix) | 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 |
| Arm III (Radiation Therapy Plus Relugolix) | 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 |
| Arm III (Radiation Therapy Plus Relugolix) | Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12 | Baseline | <30% | 4 Participants |
| Arm III (Radiation Therapy Plus Relugolix) | 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 |
| Arm III (Radiation Therapy Plus Relugolix) | 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 |
| Arm III (Radiation Therapy Plus Relugolix) | 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 |
| Arm III (Radiation Therapy Plus Relugolix) | 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 |
| Arm III (Radiation Therapy Plus Relugolix) | 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 |
Other Pre-specified
Testosterone Kinetics
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.
Time frame: Baseline and month 0, 3, 6, 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Radiation Therapy Alone) | Testosterone Kinetics | 12 | 253.631 ng/mL | Standard Error 18.149 |
| Arm I (Radiation Therapy Alone) | Testosterone Kinetics | 3 | 266.358 ng/mL | Standard Error 16.633 |
| Arm I (Radiation Therapy Alone) | Testosterone Kinetics | 6 | 260.606 ng/mL | Standard Error 17.815 |
| Arm I (Radiation Therapy Alone) | Testosterone Kinetics | 0 | 254.433 ng/mL | Standard Error 16.365 |
| Arm II (Radiation Therapy Plus Leuprolide) | Testosterone Kinetics | 3 | 37.483 ng/mL | Standard Error 10.254 |
| Arm II (Radiation Therapy Plus Leuprolide) | Testosterone Kinetics | 12 | 142.007 ng/mL | Standard Error 18.503 |
| Arm II (Radiation Therapy Plus Leuprolide) | Testosterone Kinetics | 0 | 292.735 ng/mL | Standard Error 15.114 |
| Arm II (Radiation Therapy Plus Leuprolide) | Testosterone Kinetics | 6 | 31.063 ng/mL | Standard Error 8.018 |
| Arm III (Radiation Therapy Plus Relugolix) | Testosterone Kinetics | 12 | 199.673 ng/mL | Standard Error 16.573 |
| Arm III (Radiation Therapy Plus Relugolix) | Testosterone Kinetics | 0 | 254.548 ng/mL | Standard Error 15.828 |
| Arm III (Radiation Therapy Plus Relugolix) | Testosterone Kinetics | 6 | 25.538 ng/mL | Standard Error 5.325 |
| Arm III (Radiation Therapy Plus Relugolix) | Testosterone Kinetics | 3 | 26.468 ng/mL | Standard Error 7.325 |