Androgen Deprivation TherapyPhase 1NCT06130995

Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

A Phase 1 study testing Relugolix and Enzalutamide in people with Androgen Deprivation Therapy and Locally Advanced Prostate Cancer, run by University of Oklahoma 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

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Androgen Deprivation Therapy, Locally Advanced Prostate Cancer
What is being tested?: Relugolix and Enzalutamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteUnited States
Study dates: 26 Dec 2024to Jan 2030
Phase: Phase 1
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

Capable of giving signed informed consent;
Patients must be ≥18 years of age at the time of signing the informed consent form.
Men with a diagnosis of adenocarcinoma of the prostate pathologically proven diagnosis with the following:
Locally advanced high-risk prostate defined as i. PSA >20 ng/mL or ISUP grade 4/5 (Gleason score >7) or cT2c or ii. Any PSA, any ISUP grade, cT3-4 or cN+ (locally advanced)
Have normal organ and bone marrow function measured at the screening visit including
Platelets ≥100 × 103/microliter (μL);

Show all 15Show fewer

Hemoglobin ≥ 10.0 grams/dL;
Leukocytes (WBC) ≥ 3 × 103/μL;
Absolute neutrophil count ≥1.5 × 103/μL;
Serum AST and ALT ≤2.5 × upper limit of normal (ULN);
Total bilirubin ≤1.5 ×ULN (unless values are consistent with Gilbert's syndrome for which the total bilirubin must be < 3x ULN);
Serum creatinine ≤ 1.5 × ULN; OR Measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
The participant has, in the opinion of the investigator, a life expectancy of at least 6 months.
Male patients must be willing to use contraception during treatment and for 3 months after the last dose of study treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.

Who cannot join

History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months.
Patients who are receiving any other investigational agents.
Patients with distant metastatic cancer will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population.
Active secondary malignancies requiring treatment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of study drugs
Participants with uncontrolled intercurrent illness.
Participant is unable to swallow pills.
Not a candidate for surgical or radiation therapy

Trial locations and contacts

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

lead onco nurse, RN contact

405-271-8777

SCCIITOffice@ouhsc.edu

Kelly Stratton, MD contact

(405) 271-6900

Kelly-Stratton@ouhsc.edu

United States1 site, 1 recruiting

Stephenson Cancer Center at OU Health, University of Oklahoma Health Sciences Center (SCC-OUHSC)
Oklahoma City, Oklahoma, 73104
Kelly Stratton, MD, 405-271-6900, Kelly-Stratton@ouhsc.edu
Recruiting

Other trials in United States

About this study

Official title: Phase IB Trial of Relugolix and Enzalutamide as Neoadjuvant/ Adjuvant to Local-regional Treatment in Patients With High-risk Locally Advanced Prostate CAncer (RENAPCA)

The goal of this clinical trial is to test how effective and safe it is to use a combination of two medications, relugolix and enzalutamide, in patients with advanced prostate cancer. We want to see if this combination can help improve the chances of curing the cancer and make the patients live longer without the cancer getting worse.

The main questions we want to answer in this study are:

Can using relugolix and enzalutamide together help increase the chances of curing high-risk advanced prostate cancer?
Does this combination treatment help patients live longer without their cancer getting worse?

Participants in this study will be asked to take relugolix and enzalutamide as part of their cancer treatment. They will also undergo Radiation Therapy or prostatectomy, which are standard treatments for this type of cancer.

Read the detailed description

This clinical trial aims to assess the effectiveness and safety of combining relugolix and enzalutamide as neoadjuvant and adjuvant androgen deprivation therapy (ADT) in patients diagnosed with high-risk locally advanced prostate cancer who are also candidates for definitive radiation therapy (RT) or surgical treatment. The objectives of this phase Ib clinical trial are to evaluate the efficacy, safety, and dynamic changes in biomarkers associated with this combination therapy. A combined total of up to 41 evaluable patients will participate in this study, with the initial safety lead-in cohorts involving a potential enrollment of 12 patients, followed by a dose expansion cohort that may include up to 29 subjects.

The combined treatment cycle spans 28 days, with patients receiving six months of neoadjuvant therapy followed by an additional 18 months in the adjuvant setting. Treatment duration may be shortened if unacceptable toxicity occurs or if a patient withdraws consent. Approximately 24 months of post-accrual follow-up are anticipated to adequately assess the efficacy and safety of the treatment.

Ultimately, the study aims to contribute valuable insights into the potential benefits of neoadjuvant and adjuvant hormonal therapy with relugolix plus enzalutamide in improving outcomes for patients facing high-risk locally advanced prostate cancer.

Conditions: Androgen Deprivation Therapy, Locally Advanced Prostate Cancer
Being tested: Relugolix and Enzalutamide
Keywords: dose limiting toxicity (DLTs), pathologic complete response (pCR), minimal residual disease (MRD), radiation therapy (RT)
Medical subject headings: Pathologic Complete Response, Neoplasm, Residual

What participants receive

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

Relugolix and EnzalutamideDrug
Dose level of Relugolix and Enzalutamide Safety Lead-in Cohort, 3-12 patient. Relugolix;120 mg, oral, once daily, with a loading dose of 360 mg on day 1, Enzalutamide; 120-160 mg, oral, once daily.
Dose Expansion Cohort, up to 34 patients. Relugolix;120 mg, oral, once daily, with a loading dose of 360 mg on day 1, Enzalutamide; To be determined by safety lead-in cohort.
One cycle = 3 months The dose limiting toxicity (DLT) period is the first 28 days
Neoadjuvant ADT: 6 months; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily
Concurrent ADT during Radiation Therapy; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily
Maintenance ADT: Additional 18 months; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily

Study groups in NCT06130995
Study group	Role	What they receive
Prostate Cancer Combo Therapy Trial	Experimental	A single-arm Phase Ib study explores the effectiveness and safety of neoadjuvant and adjuvant hormonal therapy combining relugolix and enzalutamide in high-risk locally advanced prostate cancer patients eligible for ADT followed by radiation therapy or surgery. Receives: Drug: Relugolix and Enzalutamide

What is being measured

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

Proportion of patient experiencing dose limiting toxicity (DLT) and tolerable dose of relugolix and enzalutamide combination
Proportion of patients will undergo evaluation for dose-limiting toxicity (DLT) to establish a tolerable dosage regimen for the combined use of relugolix and enzalutamide in individuals diagnosed with high-risk locally advanced prostate cancer. The assessment hinges on identifying DLTs associated with this treatment using 3-12 patients from the safety lead-in cohort and continuously monitoring treatment-related adverse events throughout the DLT observation period, which spans 24 months, encompassing neoadjuvant and adjuvant treatment phases.
Measured: 2-3 years
Proportion of patients experiencing Pathologic Complete Response (pCR) and Minimal Residual Disease (MRD) in Neoadjuvant ADT with the combination of Relugolix and Enzalutamide
Proportion of patients achieving a pathologic response rate, defined as the combined Pathologic Complete Response (pCR) Rate and Minimal Residual Disease (MRD) rate (MRD, tumor ≤5 mm), serves as the primary endpoint for the dose expansion cohort. This assessment will be conducted using Simon's optimal 2-stage design, enabling a determination of whether there are an adequate number of patients with objective responses to proceed to the second stage of the study (at the interim analysis) or to consider the drug for further investigation in a Phase III study (at the study's conclusion).
Measured: 4-6 years

Secondary outcomes (5)

Objective response rate (ORR) of neoadjuvant ADT of relugolix and enzalutamide
Assessing the objective response rate (ORR) in patients with high-risk locally advanced prostate cancer eligible for definitive radiation therapy (RT) or radical prostatectomy, following neoadjuvant ADT with relugolix and enzalutamide. ORR will be determined based on MRI imaging confirmation, defined as the percentage of patients achieving a complete response (CR) or partial response (PR) per RECIST v1.1 criteria.
Measured: 4-6 years
Frequency and severity of adverse events of relugolix and enzalutamide
Assessment includes the rate and severity of treatment-related adverse events as per the NCI CTCAE v5 grading system.
Measured: 4 years
Prostate specific antigen (PSA) response to the combination of relugolix and enzalutamide
Measurement of prostate-specific antigen (PSA) response, includes the rate and duration of a 50% reduction in PSA levels from baseline.
Measured: 4 years
Diagnostic precision and constraints of biopsy in assessing positive margin rates and rates of pathologic downgrade.
Assessments involves diagnostic capabilities of biopsy-based analysis for prostatectomy, as reflected in the rates of positive margin in whole-mount pathology following intense neoadjuvant therapy and the pathologic downgrade compared to the initial T stage.
Measured: 4-6 years
Progression-Free Survival (PFS) in Patients Receiving Neoadjuvant Relugolix and Enzalutamide
Assessment of Progression-Free Survival (PFS); defined as the interval from the initial dose to the earliest evaluation of progression according to RECIST v1.1 criteria, in patients undergoing neoadjuvant treatment with Relugolix and Enzalutamide, followed by radical local-regional Radiation Therapy (RT) or Radical Prostatectomy (RP) and subsequent adjuvant maintenance Androgen Deprivation Therapy (ADT).
Measured: 4-6 years

Timeline

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

26 Dec 2024Jan 2030

First posted14 Nov 2023
Study start26 Dec 2024
Primary completionJan 2029 (estimated)
Study completionJan 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Androgen Deprivation TherapyStudies of the same condition, open and under way.
More trials run by University of OklahomaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Not applicable
Intervention model: Sequential
Model description: This is a single arm phase Ib study with safety lead-in cohorts to investigate the efficacy and safety of neoadjuvant and adjuvant hormonal therapy with relugolix plus enzalutamide in patients with high-risk locally advanced prostate cancer who are candidates for ADT followed by definitive radiation therapy (RT) or surgical treatment.
Masking: None (open label)
Enrolment: 46 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06130995
Sponsor's protocol ID: OU-SCC-RENAPCA
Status last verified: Mar 2026
First submitted: 7 Nov 2023
Last updated: 5 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Loper M, Qadar A, Vesely SK, Gunter T, Ayanambakkam A, Wen Y, Cookson M, Stratton K. Neoadjuvant/adjuvant relugolix and enzalutamide for the treatment of high-risk locally advanced prostate cancer: study protocol of the RENAPCA phase Ib trial. BMJ Open. 2026 Apr 24;16(4):e112623. doi: 10.1136/bmjopen-2025-112623.
PubMed 42031503

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IB Trial of Relugolix and Enzalutamide as Neoadjuvant/ Adjuvant to Local-regional Treatment in Patients With High-risk Locally Advanced Prostate CAncer (RENAPCA)
ClinicalTrials.gov ID: NCT06130995
Acronym / sponsor ID: OU-SCC-RENAPCA
Conditions: Androgen Deprivation Therapy, Locally Advanced Prostate Cancer
Keywords: dose limiting toxicity (DLTs), pathologic complete response (pCR), minimal residual disease (MRD), radiation therapy (RT)
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 46 participants (estimated)
Lead sponsor: University of OklahomaUniversity, hospital or other
Collaborators: Pfizer, Astellas Pharma Inc
Study start: 26 Dec 2024 (actual)
Primary completion: Jan 2029 (estimated)
Study completion: Jan 2030 (estimated)
First posted: 14 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main questions we want to answer in this study are:

Can using relugolix and enzalutamide together help increase the chances of curing high-risk advanced prostate cancer?
Does this combination treatment help patients live longer without their cancer getting worse?

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: This is a single arm phase Ib study with safety lead-in cohorts to investigate the efficacy and safety of neoadjuvant and adjuvant hormonal therapy with relugolix plus enzalutamide in patients with high-risk locally advanced prostate cancer who are candidates for ADT followed by definitive radiation therapy (RT) or surgical treatment.

Arm	Type	Receives
Prostate Cancer Combo Therapy Trial	Experimental	Drug: Relugolix and EnzalutamideA single-arm Phase Ib study explores the effectiveness and safety of neoadjuvant and adjuvant hormonal therapy combining relugolix and enzalutamide in high-risk locally advanced prostate cancer patients eligible for ADT followed by radiation therapy or surgery.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Capable of giving signed informed consent;
Patients must be ≥18 years of age at the time of signing the informed consent form.
Men with a diagnosis of adenocarcinoma of the prostate pathologically proven diagnosis with the following:
Have normal organ and bone marrow function measured at the screening visit including
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Key exclusion criteria (8 listed)

History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months.
Patients who are receiving any other investigational agents.
Patients with distant metastatic cancer will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population.
Active secondary malignancies requiring treatment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of study drugs

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Relugolix and EnzalutamideDose level of Relugolix and Enzalutamide Safety Lead-in Cohort, 3-12 patient. Relugolix;120 mg, oral, once daily, with a loading dose of 360 mg on day 1, Enzalutamide; 120-160 mg, oral, once daily. Dose Expansion Cohort, up to 34 patients. Relugolix;120 mg, oral, once daily, with a loading dose of 360 mg on day 1, Enzalutamide; To be determined by safety lead-in cohort. One cycle = 3 months The dose limiting toxicity (DLT) period is the first 28 days Neoadjuvant ADT: 6 months; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily Concurrent ADT during Radiation Therapy; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily Maintenance ADT: Additional 18 months; Relugolix: 120 mg orally, daily (with a 360 mg loading dose on day 1, Enzalutamide: 160 mg (or 120 mg) orally, daily	Drug	Prostate Cancer Combo Therapy Trial

Primary outcome

Proportion of patient experiencing dose limiting toxicity (DLT) and tolerable dose of relugolix and enzalutamide combination
Time frame: 2-3 years
Proportion of patients will undergo evaluation for dose-limiting toxicity (DLT) to establish a tolerable dosage regimen for the combined use of relugolix and enzalutamide in individuals diagnosed with high-risk locally advanced prostate cancer. The assessment hinges on identifying DLTs associated with this treatment using 3-12 patients from the safety lead-in cohort and continuously monitoring treatment-related adverse events throughout the DLT observation period, which spans 24 months, encompassing neoadjuvant and adjuvant treatment phases.
Proportion of patients experiencing Pathologic Complete Response (pCR) and Minimal Residual Disease (MRD) in Neoadjuvant ADT with the combination of Relugolix and Enzalutamide
Time frame: 4-6 years
Proportion of patients achieving a pathologic response rate, defined as the combined Pathologic Complete Response (pCR) Rate and Minimal Residual Disease (MRD) rate (MRD, tumor ≤5 mm), serves as the primary endpoint for the dose expansion cohort. This assessment will be conducted using Simon's optimal 2-stage design, enabling a determination of whether there are an adequate number of patients with objective responses to proceed to the second stage of the study (at the interim analysis) or to consider the drug for further investigation in a Phase III study (at the study's conclusion).

5 secondary outcomes

Objective response rate (ORR) of neoadjuvant ADT of relugolix and enzalutamide
Time frame: 4-6 years
Frequency and severity of adverse events of relugolix and enzalutamide
Time frame: 4 years
Prostate specific antigen (PSA) response to the combination of relugolix and enzalutamide
Time frame: 4 years
Diagnostic precision and constraints of biopsy in assessing positive margin rates and rates of pathologic downgrade.
Time frame: 4-6 years
Progression-Free Survival (PFS) in Patients Receiving Neoadjuvant Relugolix and Enzalutamide
Time frame: 4-6 years

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Derived from this study: PubMed 42031503Loper M, Qadar A, Vesely SK, Gunter T, Ayanambakkam A, Wen Y, Cookson M, Stratton K. Neoadjuvant/adjuvant relugolix and enzalutamide for the treatment of high-risk locally advanced prostate cancer: study protocol of the RENAPCA phase Ib trial. BMJ Open. 2026 Apr 24;16(4):e112623. doi: 10.1136/bmjopen-2025-112623.
Individual participant dataSharing planned: No

Related trials for Androgen Deprivation Therapy

RecruitingPhase 2
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
High-risk Localized Prostate Cancer
RecruitingObservational study
A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Low-volume Metastasis
RecruitingPhase 4
A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)
Non-metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 2
A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer
Prostate Cancer
RecruitingPhase 3
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
Prostate Cancer, mHSPC

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

lead onco nurse, RN contact

405-271-8777

SCCIITOffice@ouhsc.edu

Kelly Stratton, MD contact

(405) 271-6900

Kelly-Stratton@ouhsc.edu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Relugolix and Enzalutamide in people with Androgen Deprivation Therapy and Locally Advanced Prostate Cancer, run by University of Oklahoma 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 15 inclusion and 8 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 5 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 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?

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 lead onco nurse, RN (405-271-8777, SCCIITOffice@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patient experiencing dose limiting toxicity (DLT) and tolerable dose of relugolix and enzalutamide combination (time frame: 2-3 years). 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 NCT06130995, which also lists 1 linked publication.

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 5 Mar 2026.