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Metastatic Castration-Resistant Prostate CancerPhase 1NCT04666129

Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

A Phase 1 study testing Relugolix, Abiraterone and Prednisone in people with Metastatic Castration-Resistant Prostate Cancer and Metastatic Castration-Sensitive Prostate Cancer, run by Sumitomo Pharma America, Inc. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Relugolix, Abiraterone and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
16 sitesUnited States
Study dates
18 Feb 2021to 28 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • A previous diagnosis of adenocarcinoma of the prostate confirmed by histologic or cytologic evidence and with a documented medical history of either:
  • mCSPC (Parts 1, 2, and 3) defined as having at least two of three risk factors at the baseline (Day 1) visit:
  • Total Gleason score of ≥ 6; and
  • Presence of ≥ 2 metastatic lesions on bone scan; OR
  • Radiologic evidence of measurable visceral metastases with exception of hepatic metastases.
  • nmCRPC (Part 2 only) defined as disease progression despite maintaining castration levels of testosterone with androgen deprivation therapy (ADT), as evidenced by an increase in consecutive prostate-specific antigen (PSA) concentrations (2 measurements, at least one week apart).
Show all 14Show fewer
  • mCRPC (Parts 1 and 3) defined as disease progression despite maintaining castration levels of testosterone with ADT:
  • An increase in consecutive PSA (2 measurements at least 1 week apart); or
  • Worsening clinical symptoms; or
  • Radiologic evidence demonstrating enlarged metastatic lesions or the development of new metastases.
  • Initiating treatment or currently receiving treatment of leuprolide acetate (3-, 4-, or 6-month injections [intramuscular Lupron or subcutaneous Eligard]) or another GnRH receptor agonist (triptorelin) or a GnRH receptor antagonist (degarelix or relugolix [maximum duration of 3 months]) in combination with:
  • Part 1: abiraterone acetate 1000 mg or fine-particle abiraterone acetate 500 mg once daily plus prednisone 5 mg once daily for participants with mCSPC or twice daily for participants with mCRPC or methylprednisolone 4 mg once daily and in whom abiraterone has been well tolerated (that is, without evidence of hepatotoxicity requiring dose adjustment for abiraterone).
  • Part 2: apalutamide 240 mg once daily and in whom apalutamide has been well tolerated (that is, without a fracture, fall, or seizure episode or need to dose adjust due to any adverse events).
  • Part 3: docetaxel 75 mg/m2 and in whom docetaxel has been well tolerated (that is, no evidence of hypersensitivity reaction, febrile neutropenia or neutrophils < 500 cells/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or moderate neurosensory signs and/or symptoms despite dose reduction). Note: Patients receiving treatment with another agent in addition to docetaxel, such as a steroid synthesis inhibitor or androgen receptor antagonist, may be enrolled.

Who cannot join

  • A patient will not be eligible for inclusion in the study if any of the following criteria apply:
  • A medical history of brain or hepatic metastases based on radiologic evidence or a medical history of surgical castration;
  • Received combination treatment with a GnRH analog or GnRH receptor antagonist with either abiraterone acetate plus a corticosteroid (Part 1) or apalutamide (Part 2) in patients with mCSPC (Part 1 and Part 2) or nmCRPC (Part 2) for a total duration > 24 months or in patients with mCRPC (Part 1) for a total duration > 6 months;
  • Is scheduled or anticipates being scheduled for major surgery during the study treatment period;
  • A current diagnosis of a malignancy other than prostate cancer, with the exception of any of the following:
  • Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of any type;
Show all 35Show fewer
  • Adequately treated Stage I cancer that is currently in remission and has been in remission for ≥ 2 years;
  • Any other cancer from which the patient has been disease-free for ≥ 3 years;
  • Abnormal clinical laboratory test value(s) at the screening visit or prior to the baseline (Day 1) visit including:
  • Serum creatinine > 2.0 mg/dL;
  • Platelets < 100 × 103/μL;
  • Hemoglobin < 10.0 g/dL;
  • Leukocytes (WBC) < 3 × 103/μL;
  • Absolute neutrophil count < 1.5 × 103/μL;
  • Hemoglobin A1c (HbA1c) > 8%; Note (Part 3 only): Transfusions and/or administration of growth factors are permitted as indicated for the clinical management of docetaxel-related hematologic effects and in accordance with the investigator's judgement.
  • Known hepatic disease, including alcoholic liver disease or viral hepatitis such as hepatitis A (hepatitis A virus IgM positive), chronic hepatitis B (HbsAg positive), or chronic hepatitis C (HCV antibody positive, confirmed by HCV RNA) or clinical signs of hepatic disease such as jaundice;
  • A medical history within 6 months prior to the screening visit or a current diagnosis of any of the following:
  • Myocardial infarction;
  • Unstable angina;
  • Unstable symptomatic ischemic heart disease;
  • Congestive heart failure classified as NYHA class III or IV heart failure;
  • Thromboembolic event(s) (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular event[s]);
  • Any other significant cardiac condition (eg, pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease);
  • An abnormal ECG;
  • Uncontrolled hypertension;
  • Hypotension;
  • Bradycardia;
  • Positive HIV;
  • Medical history of a bleeding disorder or current clinical evidence of gastrointestinal bleeding or active bleeding from another anatomical location;
  • A medical history within 1 year of the screening visit of drug or alcohol abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders V;
  • Received an investigational drug within 28 days or 5 half-lives, whichever is longer, prior to the baseline (Day 1) visit;
  • Prior use of any prohibited medication(s) and restrictive medication(s) without the appropriate washout period or use of a prohibited medication during the study treatment period is planned;
  • A contraindication or known history of hypersensitivity to any of the study treatments or components thereof, or has a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates study participation;
  • Any other medical or psychiatric condition that, in the opinion of the investigator, would interfere with accomplishing the study objectives or the patient completing the study;
  • Is a study site employee or is a primary family member (spouse, parent, child, or sibling) of a site employee involved in the conduct of the study.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Center for Advanced Urology, LLP d/b/a: MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Chesapeake Urology Research Associates

    Baltimore, Maryland, 21204

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Alliance Urology

    Greensboro, North Carolina, 27403

  • Colorodo Clinical Research

    Lakewood, Colorado, 80228

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • Helios Clinical Research, LLC.

    Middleburg Heights, Ohio, 44130

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

  • New Jersey Urology

    Saddle Brook, New Jersey, 07663

  • Urology San Antonio

    San Antonio, Texas, 78229

  • Urological Associates of Southern Arizona, P.C.

    Tucson, Arizona, 85741

  • Clinical Research Alliance, Inc.

    Westbury, New York, 11590

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Phase 1, Three-Part, Open-Label, Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination With Abiraterone Acetate Plus a Corticosteroid, Apalutamide, or Docetaxel With or Without Prednisone in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).

Read the detailed description

This is a three-part, open-label, parallel-cohort study to assess the safety and tolerability of relugolix as the ADT component in combination treatment with abiraterone acetate plus a corticosteroid in patients with mCSPC or mCRPC (Part 1), apalutamide in patients with mCSPC or nmCRPC (Part 2), or docetaxel with or without prednisone in patients with mCSPC or mCRPC (Part 3).

The study will consist of a 45-day screening period followed by a 12-week treatment period with one of the three combination treatments (Parts 1, 2, or 3). All participants are required to be currently or previously treated with a GnRH receptor antagonist (analog), leuprolide acetate or triptorelin, or a GnRH receptor antagonist, degarelix or relugolix, in combination with either abiraterone plus prednisone (Part 1), apalutamide (Part 2), or docetaxel (Part 3). The study consists of a 12-week primary study treatment period in which safety and tolerability, including assessment of vital sign measurements, ECGs, clinical laboratory tests and reporting of adverse events every 2 to 4 weeks, followed by a 40-week safety extension treatment period during which adverse events and changes to concomitant medications will be reported. The total treatment duration is 52 weeks.

Being tested
Relugolix, Abiraterone, Prednisone, Methylprednisolone, Apalutamide
Keywords
mCRPC, mCSPC, Relugolix, Abiraterone, Prednisone, Leuprolide acetate, nmCRPC, Apalutamide, Docetaxel, Degarelix, Methylprednisolone

What participants receive

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

  • RelugolixDrug

    Also called MVT-601, TAK-385, T-1331285, RVT-601

    (Part 1 and Part 3) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 120-mg dose (1 x 120-mg tablets), taken once daily at approximately the same time each day.

    (Part 2) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 240-mg dose (2 x 120-mg tablets), taken once daily at approximately the same time each day.

  • AbirateroneDrug

    Also called Zytiga, Yonsa

    Abiraterone acetate (1000 mg [2 x 500-mg tablets]) or fine-particle abiraterone acetate (500 mg [4 x 125-mg tablets]) will be administered orally once daily.

  • PrednisoneDrug

    (Part 1 only) For participants with mCSPC, a 5-mg dose of prednisone will be administered orally once daily, and for participants with mCRPC, a 5-mg dose of prednisone will be administered orally twice daily.

    (Part 3 only) Prednisone 5 mg can be administered orally twice daily but is not required.

  • MethylprednisoloneDrug

    Also called Medrol

    For participants with mCRPC taking fine-particle abiraterone acetate, methylprednisolone 4 mg will be administered orally twice daily.

  • ApalutamideDrug

    Also called Erleada

    Apalutamide 240 mg (4 x 60-mg tablets) will be administered orally once daily.

  • DocetaxelDrug

    Also called Docefrez, Taxotere

    Docetaxel 75 mg/m2 dose will be administered every 3 weeks as a 1-hour intravenous infusion.

Study groups in NCT04666129
Study groupRoleWhat they receive
Part 1: Relugolix plus Abiraterone plus a CorticosteroidExperimentalParticipants will receive relugolix in combination with abiraterone plus a corticosteroid for 12 weeks during the study treatment period.
Receives: Drug: Relugolix; Drug: Abiraterone; Drug: Prednisone; Drug: Methylprednisolone
Part 2: Relugolix plus ApalutamideExperimentalParticipants will receive relugolix in combination with apalutamide for 12 weeks during the study treatment period.
Receives: Drug: Relugolix; Drug: Apalutamide
Part 3: Relugolix plus Docetaxel with or without PrednisoneExperimentalParticipants will receive relugolix in combination with docetaxel with or without prednisone for 12 weeks during the study treatment period.
Receives: Drug: Relugolix; Drug: Prednisone; Drug: Docetaxel

What is being measured

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

  1. Incidence of Adverse Events

    Parts 1, 2, and 3

    Measured: Baseline through Week 13

Secondary outcomes (9)

  1. Mean Testosterone Serum Concentrations at Baseline (Day 1), Week 5, and Week 13

    Parts 1 and 2

    Measured: Baseline (Day 1), Week 5, and Week 13

  2. Number and Proportion of Participants with Testosterone Concentrations ≥ 50 ng/dL at Baseline (Day 1), Week 5, and Week 13

    Parts 1 and 2

    Measured: Baseline (Day 1), Week 5, and Week 13

  3. Relugolix Trough Concentrations at Baseline (Day 1), Week 3, Week 5, Week 9, and Week 13

    Part 2

    Measured: Baseline (Day 1), Week 3, Week 5, Week 9, and Week 13

  4. Apalutamide and N-desmethyl Apalutamide Trough Concentrations at Baseline (Day 1), Week 3, Week 5, Week 9, and Week 13

    Part 2

    Measured: Baseline (Day 1), Week 3, Week 5, Week 9, and Week 13

  5. Mean Testosterone Serum Concentrations at Baseline (Day 1), Mid-Treatment, and Week 13

    Part 3

    Measured: Baseline (Day 1), Mid-Treatment, and Week 13

  6. Number and Proportion of Participants with Testosterone Concentrations ≥ 50 ng/dL at Baseline (Day 1), Mid-Treatment (Treatment Cycle that Most Closely Corresponds to Week 7 of the Primary Study Treatment Period), and Week 13

    Part 3

    Measured: Baseline (Day 1), Mid-Treatment (Treatment Cycle that Most Closely Corresponds to Week 7 of the Primary Study Treatment Period), and Week 13

  7. Relugolix Concentrations at Baseline (Day 1), In-Cycle, Mid-Treatment, and Week 13 in Each Infusion Cycle for Docetaxel

    Part 3

    Measured: Baseline (Day 1), In-Cycle, Mid-Treatment, and Week 13 in Each Infusion Cycle for Docetaxel

  8. Docetaxel Concentrations at Baseline (Day 1), In-Cycle, Mid-Treatment, and Week 13 in Each Infusion Cycle for Docetaxel

    Part 3

    Measured: Baseline (Day 1), In-Cycle, Mid-Treatment, and Week 13 in Each Infusion Cycle for Docetaxel

  9. Incidence of Adverse Events

    Parts 1, 2, and 3

    Measured: Up to 52 weeks

Timeline

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

  1. First posted14 Dec 2020
  2. Study start18 Feb 2021
  3. Primary completion28 May 2024
  4. Study completion28 May 2024

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04666129
Sponsor's protocol ID
MVT-601-049
Status last verified
Aug 2025
First submitted
7 Dec 2020
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • De La Cerda J, Belkoff L, Courtney KD, Diamond E, D'Olimpio J, Dunshee C, Gervasi L, Goodman M, Mittal K, Morris D, Sieber P, Tutrone R, Ryan M, Zhong Y, Ufer M, Shore N. Safety and Tolerability of Relugolix in Combination with Abiraterone or Apalutamide for Treatment of Patients with Advanced Prostate Cancer: Data from a 52-Week Clinical Trial. Target Oncol. 2025 May;20(3):503-517. doi: 10.1007/s11523-025-01139-3. Epub 2025 Apr 4.

    PubMed 40180682

  • De La Cerda J, Dunshee C, Gervasi L, Sieber P, Belkoff L, Tutrone R, Lu S, Gatoulis SC, Brown B, Migoya E, Shore N. A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer. Target Oncol. 2023 May;18(3):383-390. doi: 10.1007/s11523-023-00967-5. Epub 2023 Apr 15.

    PubMed 37060432

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Relugolix, Abiraterone and Prednisone in people with Metastatic Castration-Resistant Prostate Cancer and Metastatic Castration-Sensitive Prostate Cancer, run by Sumitomo Pharma America, Inc. at 16 sites 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 14 inclusion and 35 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: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: Baseline through Week 13). 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 NCT04666129, which also lists 2 linked publications.

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 17 Aug 2025.

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