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Prostate AdenocarcinomaPhase 2NCT06330805

Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

A Phase 2 study testing Biospecimen Collection, Contrast Agent and Leuprolide in people with Prostate Adenocarcinoma and Stage IIB Prostate Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Biospecimen Collection, Contrast Agent and Leuprolide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
12 Aug 2024to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration.
  • Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:
  • Has at least one intermediate risk factor (IRF):
  • Prostate-specific antigen (PSA) 10-20 ng/mL
  • Clinical stage tumor (T)2b-c (digital rectal exam [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition
  • Gleason Score 7 (Gleason 3+4 or 4+3 [International Society of Urological Pathology [ISUP] grade group 2-3])
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  • Has one or more of the following "unfavorable" intermediate-risk designators:
  • > 1 IRF
  • Gleason 4+3=7 (ISUP grade group 3)
  • ≥ 50% of biopsy cores positive
  • Biopsies may include "sextant" sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such "sextant" biopsy cores should be counted. Men may also undergo "targeted" sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s).
  • Absence of high-risk features
  • Appropriate stage based on the following diagnostic workup:
  • History/physical examination within 120 days prior to registration
  • Negative bone imaging (M0) with Tc-99m bone scan or fluciclovine (18F) sodium fluoride (NaF) positron emission tomography (PET) within 120 days prior to registration
  • Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +/- abdominal CT or MRI), within 120 days prior to registration (lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.0 cm in short axis and/or if biopsy is negative)
  • Prostate specific membrane antigen (PSMA) or fluciclovine PET negative for nodal or distant metastatic disease is an acceptable substitute for the above bone and pelvic imaging
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 within 120 days prior to registration.
  • Non-castrate testosterone level (> 50 ng/dL) within 120 days prior to registration.
  • Absolute neutrophil ≥ 1,000 cells/mm^3 (within 120 days prior to registration)
  • Hemoglobin ≥ 10 g/dL (within 120 days prior to registration)
  • Platelet count ≥ 100,000 cells/mm^3 (within 120 days prior to registration)
  • Creatinine clearance (CrCl) ≥ 30 mL/min estimated by Cockcroft-Gault Equation (within 120 days prior to registration)
  • For African American patients, CrCl ≥ 30 mL/min is estimated by the alternative formula that takes race into account
  • Total bilirubin: 1.5 ≤ institutional upper limit of normal (ULN) (within 120 days prior to registration)
  • Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase [SGPT]) ≤ 2.5 × institutional ULN (within 120 days prior to registration)
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility for this protocol.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B).
  • For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.

Who cannot join

  • Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, High-intensity focused ultrasound (HIFU), laser thermal ablation, etc.) for prostate cancer.
  • Definitive clinical or radiologic evidence of metastatic disease (M1).
  • Prior invasive malignancy (except non-melanomatous skin cancer) or hematologic malignancy unless disease free for a minimum of 3 years.
  • Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields.
  • Previous bilateral orchiectomy.
  • Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed.
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  • Prior use of 5-alpha-reductase inhibitors is allowed; however, it must be stopped ≥ 30 days prior to the pre-registration PSA measure for determining enrollment eligibility.
  • Prior testosterone replacement therapy is allowed; however, any replacement therapy must be stopped for at least 1 year prior to registration.
  • Severe, active co-morbidity defined as follows:
  • Current/uncontrolled angina or arrhythmias
  • New York Heart Association Functional Classification II-IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
  • History of any condition that in the opinion of the investigator, would preclude participation in this study
  • Patients with significant obstructive urinary symptoms that are suspected to be secondary to prostate cancer and/or benign prostatic hypertrophy.
  • Disabilities that prevent performing moderate intensity exercise test with exercise (treadmill) stress test and muscle function tests (walking/gait assessments and grip strength).
  • Patients unable to tolerate MRI (e.g. claustrophobia), has contraindications to MRI (e.g. metals and implants incompatible with MRI), body habitus preventing MRI scanning, or allergy to gadolinium-based contrast.
  • Significant uncontrolled gastrointestinal (e.g. Crohn's disease, ulcerative colitis) or metabolic disease (e.g. diabetes, hyperlipidemia).
  • Active inflammatory or immune-related disease treated with steroids or immunosuppressive agents.
  • Inability to swallow oral pills.
  • High risk features, which includes any of the following:
  • Gleason 8-10 [ISUP grade group 4-5]
  • PSA>20
  • cT3-4 by digital exam OR gross extra-prostatic extension on imaging [indeterminate MRI evidence will not count and the patient will be eligible]

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Shang-Jui Wang, 614-366-9306, Shang-Jui.Wang@osumc.edu

    Shang-Jui Wang

    Recruiting

Other trials in United States

About this study

Official title: A Comparison of Orgovyx (Relugolix) vs Eligard (Leuprolide) on Cardiovascular Function and Biomarkers During Standard of Care Combined ADT (Androgen Deprivation Therapy)-Radiation for Prostate Cancer

This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes.

Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following:

  1. Comprehensive cardiac and exercise testing before and after starting ADT
  2. Completion of quality-of-life questionnaires at specific intervals during the study period
  3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers
Read the detailed description

PRIMARY OBJECTIVES:

  1. To quantify the physiologic alterations in cardiopulmonary function in men receiving 6-month relugolix verse (vs.) 6-month leuprolide with definitive radiation therapy (RT) for unfavorable intermediate risk (UIR) clinically localized prostate cancer (PCa).

II. Cardiopulmonary and cardiac measures obtained from: 1) exercise stress cardiac magnetic resonance imaging (MRI) perfusion, and 2) maximal rate of oxygen consumption (VO2), include myocardial perfusion reserve index (MPRI), contractile reserve, myocardial longitudinal relaxation time (T1) signal, longitudinal strain, circumferential strain, VO2 maximum (max), and metabolic equivalents of exercise capacity (METs).

SECONDARY OBJECTIVES:

  1. To quantify the impact of 6-month relugolix vs. leuprolide with definitive RT for UIR PCa on quality of life (QoL) using Expanded Cancer Index Composite (EPIC)-26, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), European (Euro) Qol-5-Dimension 5-level (EQ-5D-5L), and Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 8a) patient-reported outcome surveys, or similar tests.

II. To quantify the impact of 6-month relugolix vs. leuprolide on composite functional tests of strength and balance using three tests: 1) Timed Up-and-Go, 2) 10-meter walk time, and 3) grip strength.

III. To analyze body composition changes in response to 6-month relugolix vs. leuprolide by using abdominal computed tomography (CT) or magnetic resonance imaging (MRI) to quantitate abdominal/visceral fat and lean muscle mass with utilization of SliceOmatic software.

EXPLORATORY OBJECTIVES:

  1. To compare changes in serum steroid profiles (panel of 17 steroid hormone metabolites, Ohio State University Comprehensive Cancer Center [OSUCCC Pharmacoanalytic Shared Resource [PhASR]) before, during and after 6-month relugolix vs. 6-month leuprolide with definitive RT for UIR PCa.

II. To compare changes in cardiometabolic biomarkers in the following three categories: 1) glycemic control parameters (fasting glucose, fasting insulin, and connecting [C]-peptide), 2) lipid profiles (total cholesterol, triglyceride, low-density lipoprotein [LDL], high-density lipoprotein [HDL], and leptin/adiponectin ratio), 3) markers of the obesity-associated low-grade chronic inflammatory state (CRP, TGF-beta, and IL-6, and novel related immunoregulators), and targeted or non- targeted metabolomics or proteomics (by OSUCCC NPASR and PSR) depending on procurement of additional funds.

III. To compare the time course of recovery for hormonal and cardiometabolic markers after completion of 6-month relugolix vs. 6-month leuprolide with definitive RT for UIR PCa.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive definitive therapy for prostate cancer with ADT (leuprolide via injection once every 3 months, for a total of 6 months) in the absence of disease progression or unacceptable toxicity and definitive radiotherapy within 90 days of starting ADT. Patients receive gadolinium-based contrast intravenously (IV) and undergo exercise-stress cardiac MRI perfusion and comprehensive exercise physiology testing before starting ADT and at 6 months after starting ADT. Patients also undergo blood and urine sample collection throughout the study, as well as completion of quality-of-life questionnaires.

ARM 2: Patients receive definitive therapy for prostate cancer with ADT (relugolix orally once daily for a total of 6 months) in the absence of disease progression or unacceptable toxicity and definitive radiotherapy within 90 days of starting ADT. Patients receive gadolinium-based contrast intravenously (IV) and undergo exercise-stress cardiac MRI perfusion and comprehensive exercise physiology testing before starting ADT and at 6 months after starting ADT. Patients also undergo blood and urine sample collection throughout the study, as well as completion of quality-of-life questionnaires.

After completion of study treatment, patients are followed up at 1, 3, and 6 months.

Being tested
Biospecimen Collection, Contrast Agent, Leuprolide, Magnetic Resonance Imaging, Physical Performance Testing
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and urine sample collection

  • Contrast AgentOther

    Also called Contrast, Contrast Drugs, contrast material, Contrast Medium

    Given IV

  • LeuprolideDrug

    Also called Leuprorelin

    Given injection

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • Physical Performance TestingOther

    Also called Physical Fitness Testing, Physical Function Testing

    Undergo functional fitness tests

  • RelugolixDrug

    Also called 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, Orgovyx, Relumina, TAK 385

    Given PO

Study groups in NCT06330805
Study groupRoleWhat they receive
Arm 1 (leuprolide)ExperimentalPatients receive definitive therapy for prostate cancer with ADT (leuprolide via injection once every 3 months, for a total of 6 months) in the absence of disease progression or unacceptable toxicity and definitive radiotherapy within 90 days of starting ADT. Patients receive gadolinium-based contrast intravenously (IV) and undergo exercise-stress cardiac MRI perfusion and comprehensive exercise physiology testing before starting ADT and at 6 months after starting ADT. Patients also undergo blood and urine sample collection throughout the study, as well as completion of quality-of-life questionnaires.
Receives: Procedure: Biospecimen Collection; Other: Contrast Agent; Drug: Leuprolide; Procedure: Magnetic Resonance Imaging; Other: Physical Performance Testing
Arm 2 (relugolix)ExperimentalPatients receive definitive therapy for prostate cancer with ADT (relugolix orally once daily for a total of 6 months) in the absence of disease progression or unacceptable toxicity and definitive radiotherapy within 90 days of starting ADT. Patients receive gadolinium-based contrast intravenously (IV) and undergo exercise-stress cardiac MRI perfusion and comprehensive exercise physiology testing before starting ADT and at 6 months after starting ADT. Patients also undergo blood and urine sample collection throughout the study, as well as completion of quality-of-life questionnaires.
Receives: Procedure: Biospecimen Collection; Other: Contrast Agent; Procedure: Magnetic Resonance Imaging; Other: Physical Performance Testing; Drug: Relugolix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physiologic alterations in cardiopulmonary function - Myocardial perfusion

    We will measure the difference in myocardial perfusion with exercise stress-rest cardiac MRI before and after ADT (leuprolide vs. relugolix).

    Measured: Up to 6 months

  2. Physiologic alterations in cardiopulmonary function - Maximal rate of oxygen consumption

    We will measure the difference in VO2 Max before and after ADT (leuprolide vs. relugolix).

    Measured: Up to 6 months

Secondary outcomes (8)

  1. Quality of life using EPIC-26

    Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale. Overall, higher scores across the EPIC domains represent better QoL.

    Measured: Up to 6 months

  2. Quality of life using EORTC QLQ-C30

    All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning.

    Measured: Up to 6 months

  3. Quality of life using European (Euro) Qol-5-Dimension 5-level (EQ-5D-5L)

    This validated utility assessment instrument evaluates 5-dimensions (5D) of function, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each graded on 5 levels (ranging from 1 [no problem] to 5 [extreme problems]). The 5D index score is transformed into a utility score between 0 and 1. The sixth item is a visual analogue scale for overall health perceived by the patient. A lower score represents better health.

    Measured: Up to 6 months

  4. Quality of life using PROMIS

    A 5-point Likert scale from 1 (never/not at all) to 5 (almost always/very much) with a recall period of last 7 days. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.

    Measured: Up to 6 months

  5. Functional tests of strength and balance using Timed Up-and-Go

    Participants will be instructed to stand up from an armchair (seat height of 45 cm), walk at a comfortable pace to a line on the floor 3 meters away, turn, return to the chair and sit down again. A stopwatch is used to time the performance (in seconds).

    Measured: Up to 6 months

  6. Functional tests of strength and balance using 10-meter walk time

    Gait speed will be measured using a standardized 10-m course.

    Measured: Up to 6 months

  7. Functional tests of strength and balance using Grip strength

    A validated biomarker of overall strength and muscle mass. Patients will perform 3 trials with each hand, alternating hands between trials, with the maximum score for each hand being recorded.

    Measured: Up to 6 months

  8. Changes in body composition

    Abdominal CT/MRI to quantitate abdominal/visceral fat and lean muscle mass with utilization of image analysis software.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study start12 Aug 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06330805
Sponsor's protocol ID
OSU-23069
Other IDs
NCI-2024-00705
Status last verified
Mar 2026
First submitted
2 Mar 2024
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Contrast Agent and Leuprolide in people with Prostate Adenocarcinoma and Stage IIB Prostate Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physiologic alterations in cardiopulmonary function - Myocardial perfusion (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06330805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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