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Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Phase 2NCT06312670

Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

A Phase 2 study testing EPI-7386, Enzalutamide and Androgen Deprivation Therapy (ADT) in people with Metastatic Hormone-sensitive Prostate Cancer (mHSPC) and Prostate Cancer, run by Pedro Barata, MD, MSc at 2 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to… Read more about this study

Who is it for?
Ages 19 years and older, men only
What is being tested?
EPI-7386, Enzalutamide and Androgen Deprivation Therapy (ADT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesUnited States
Study dates
16 May 2024to 9 Jan 2025
Phase
Phase 2
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 19 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have histologically or cytologically confirmed prostate adenocarcinoma without small cell or neuroendocrine features (please note: >10% small cell or neuroendocrine differentiation will be excluded).
  • Subjects must have received no prior second-generation antiandrogen therapies for this disease. Androgen deprivation with LHRH agonist/antagonist therapy or history of bilateral orchiectomy that started less than 12 weeks before study enrollment is allowed.
  • Subjects may have either de novo or recurrent metastatic disease. Presence of metastatic disease at study entry documented by 1 or more lesions - bone, lymph node, soft tissue, or visceral metastases - observed by any imaging technique.
  • Age >18 years. This study will be limited to adults only.
  • Evidence of metastatic disease by conventional CT of chest, abdomen, and pelvis, and bone scans, OR Positron emission tomography (PET) scan, OR MRI.
  • ECOG performance status of 0 to 2.
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  • Subjects must have normal organ and marrow function as defined below:
  • Absolute neutrophil count >1000/μL; platelet count >100 000/μL; hemoglobin >8.5 g/dL) at screening. Note: Subjects must not have received any growth factors within 7 days or blood transfusions within 14 days prior to the hematologic laboratory values obtained at screening).
  • Total bilirubin (TBIL) <2 × the upper limit of normal (ULN) at screening, except subjects with documented Gilbert syndrome who must have a TBIL <3 mg/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 × ULN at screening
  • Creatinine clearance ≥45 mL/min and/or estimated glomerular filtration rate (eGFR) ≥30
  • Albumin >30 g/L (3.0 g/dL) at screening
  • Subjects receiving bisphosphonates or other approved bone-targeting therapy (e.g., denosumab) must be on a stable dose for at least 28 days before the start of study treatment.
  • Radiation therapy is allowed at any time, as deemed appropriate by the treating investigator.
  • Subjects of child-producing potential agree to use highly effective contraceptive methods (i.e., barrier contraception measures such as a male condom with spermicide during intercourse) and avoid sperm donation during the study treatment and for 3 months after the last dose of study treatment. A man is considered to be of child-producing potential, unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy. Partners of participants must also practice approved forms of birth control.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent form (ICF).
  • Members of all races and ethnic groups are eligible for this trial. At least ≥ 20% of enrolled subjects must be of African American descent. (self-reported).

Who cannot join

  • Evidence of mCRPC.
  • Receipt of any other investigational agents.
  • Diagnosis of another clinically significant malignancy within the previous 3 years other than curatively treated non-melanomatous skin cancer or superficial urothelial carcinoma and other in situ or noninvasive malignancies, as determined by the PI or CoPI.
  • Gastrointestinal issues affecting absorption (e.g., gastrectomy).
  • Known history of seizure or conditions that may predispose the subject to seizure, including brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, or brain arteriovenous malformation. Subjects with brain metastases/central nervous system (CNS) disease that are treated prior to enrollment will be allowed in this clinical trial.
  • Known or suspected hypersensitivity to any components of the formulation used for EPI-7386 or enzalutamide.
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  • Use of compounds known to be strong inducers of CYP3A within 30 days prior to start of study drug treatment, and strong inhibitors of CYP2C8 within 14 days of the first dose of study treatment.
  • Use of narrow therapeutic index sensitive CYP2C8 substrates (e.g., daprobustat, dasabuvir, repaglinide, paclitaxel) or sensitive substrates for CYP3A.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations considered by the Investigator to limit compliance with study requirements.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Phase 2 Trial Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks.

Read the detailed description

EPI-7386 is an investigational drug that works by blocking the androgen receptor at a different site compared to the approved androgen receptor blockers. This may increase the effectiveness of this drug and increase the effectiveness of approved androgen receptor blockers when taken together. EPI-7386 is a new drug; therefore, its effectiveness and safety in prostate cancer patients must be studied before it is approved by the Food and Drug Administration. EPI-7386 is experimental because it is not currently approved by the Food and Drug Administration (FDA). Enzalutamide is approved by the FDA for patients whose prostate cancers has spread after receiving treatment. The hypothesis is that adding EPI-7386 to standard hormone therapy will be more effective in treating cancer compared to usual treatment, with the long term goal of discovering more about hormone therapy as a treatment for cancer.

Being tested
EPI-7386, Enzalutamide, Androgen Deprivation Therapy (ADT)
Keywords
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Prostate Cancer, Androgen Deprivation Therapy, Prostate adenocarcinoma, Recurrent metastatic
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • EPI-7386Drug

    600 mg orally administered twice daily

  • EnzalutamideDrug

    160 mg administered orally once daily, with or without food

  • Androgen Deprivation Therapy (ADT)Drug

    LHRH agonist/antagonist or orchiectomy

Study groups in NCT06312670
Study groupRoleWhat they receive
EPI-7386 + EnzalutamideExperimentalEPI-7386 at 600 mg twice daily orally with standard of care Enzalutamide at 160 mg, once daily, orally for 36 months of treatment (11 cycles).
Receives: Drug: EPI-7386; Drug: Enzalutamide; Drug: Androgen Deprivation Therapy (ADT)

What is being measured

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

  1. Biochemical response rate

    Defined as prostate-specific antigen (PSA) undetectable (<0.2 ng/mL) at 6 months after treatment. The true BRR for the study population will be estimated based on the number of biochemical responses using a binomial distribution, and its confidence interval (CI) will be estimated using Wilson's method.

    Measured: Post-intervention at Week 4

  2. PSA progesterone-free survival (PFS)

    Progression free survival (PFS) is measured from the date of the start of the treatment to the date of progression or death and is censored at the date of last followed for those that have not progressed

    Measured: Post-intervention at Week 4

  3. Radiographic PFS (rPFS)

    Progression free survival (PFS) is measured from the date of the start of the treatment to the date of progression or death and is censored at the date of last followed for those that have not progressed

    Measured: Post-intervention at Week 4

  4. ORR (confirmed)

    Objective response rate (ORR)

    Measured: Post-intervention at Week 4

Secondary outcomes (12)

  1. AUC0-24

    Plasma area under the concentration-time curve from time zero to 24 hours (AUC0-24)

    Measured: Beginning of treatment day 1, at week 2, week 4, week 6

  2. Maximum concentration (Cmax)

    Total Maximum concentration

    Measured: Beginning of treatment day 1, at week 2, week 4, week 6

  3. Predose Plasma Concentration

    Observed predose plasma concentration during multiple dosing (Ctrough)

    Measured: Beginning of treatment day 1, at week 2, week 4, week 6

  4. Time to reach Cmax (Tmax)

    Time it takes to reach maximum concentration

    Measured: Beginning of treatment day 1, at week 2, week 4, week 6

  5. Terminal elimination half-life

    Apparent terminal elimination half-life (t½), whenever feasible to calculate

    Measured: Beginning of treatment day 1, at week 2, week 4, week 6

  6. Volume of distribution at steady state after extravascular administration

    Apparent volume of distribution at steady state after extravascular administration (Vss/F)

    Measured: Beginning of treatment day 1, at week 2, week 4, week 6

  7. Clearance after extravascular administration

    Apparent clearance after extravascular administration.

    Measured: Beginning of treatment day 1, at week 2, week 4, week 6

  8. Treatment-emergent adverse events

    Treatment-emergent adverse events (TEAEs) (characterized by type, frequency, severity, timing, seriousness, and relationship to study treatment)

    Measured: Post-intervention at Week 4

  9. Rate of abnormalities in clinical laboratory parameters

    The presenece of abnormalities in clinical laboratory parameters will be measured and characterized by type, frequency, severity, timing, seriousness, and relationship to study treatment.

    Measured: Baseline, 2 weeks, 11 weeks, and 20 weeks after beginning treatment

  10. Rate of abnormalities in vital sign measurements

    The presence of abnormalities in vital sign measurements will be measured and characterized by type, frequency, severity, timing, seriousness, and relationship to the study treatment.

    Measured: Post-intervention at Week 4

  11. Rate of abnormalities in electrocardiograms (ECGs)

    The presence of abnormalities in ECGs will be measured and characterized by type, frequency, severity, timing, seriousness, and relationship to the study treatment.

    Measured: At screening and beginning of treatment on day 1 of cycle 1 (each cycle is 14 days)

  12. Changes in Eastern Cooperative Oncology Group (ECOG) performance status

    Changes in ECOG performance status. The ECOG performance status relies on a scale with scores ranging from 0-5, where 0 indicates the highest function, and 5 indicates lowest function.

    Measured: Post-intervention at Week 4

Timeline

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

  1. First posted15 Mar 2024
  2. Study start16 May 2024
  3. Primary completion9 Jan 2025
  4. Study completion9 Jan 2025

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
Not applicable
Intervention model
Single group
Model description
Phase 2, single-arm study composed of 2 stages: in the first stage, 13 subjects diagnosed with mHSPC will be enrolled and treated with EPI-7386 in combination with enzalutamide. If there are 8 or less subjects with a biochemical response at 6 months, then the trial will be suspended. Otherwise, 22 additional subjects will be enrolled and treated.
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06312670
Sponsor's protocol ID
CASE2823
Status last verified
May 2025
First submitted
16 Feb 2024
Last updated
29 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie or influence the results observed from the study.

Publications

  • Jang A, Fowler P, Helminiak K, Kumar HLS, Pasucal J, Delong V, Zhong JY, Jindal T, Grier AL, Patel RR, Hislop M, Cesano A, Villaluna K, Younginger B, Wolff K, Richey K, Bray J, Garcia H, Adamowicz T, Reese A, Nizam A, Gupta S, Wee CE, Margevicius S, Fu P, Mendiratta P, Sheng IY, Brown JR, Garcia JA, Barata PC. EXTRA-PC: a phase II trial of masofaniten (EPI-7386) and enzalutamide for patients with treatment-naive metastatic hormone-sensitive prostate cancer. Oncologist. 2026 Jan 17;31(2):oyaf434. doi: 10.1093/oncolo/oyaf434.

    PubMed 41467749

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EPI-7386, Enzalutamide and Androgen Deprivation Therapy (ADT) in people with Metastatic Hormone-sensitive Prostate Cancer (mHSPC) and Prostate Cancer, run by Pedro Barata, MD, MSc at 2 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 17 inclusion and 9 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 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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?

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?

Biochemical response rate (time frame: Post-intervention at Week 4). The study lists 4 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 NCT06312670, 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 29 May 2025.

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