Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Promising combo for prostate cancer falls short: trial ends early

NCT ID NCT04179864

Disease control Sponsor: Epizyme, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug, tazemetostat, combined with standard hormone therapies (enzalutamide or abiraterone/prednisone) in men with advanced prostate cancer that no longer responds to hormone therapy alone. The goal was to see if the combination could slow cancer growth better than standard treatment alone. The trial was terminated early, meaning it did not meet its goals or faced challenges.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

102 people

The number who actually took part.

Started

Nov 2019

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age at the time of consent ≥ 18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix 3. Life expectancy of \> 3 months. 4. Histologically or cytologically confirmed adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted. 5. Progressive disease in the setting of medical or surgical castration (ie, castration- resistant prostate cancer \[CRPC\]) by PCWG3 criteria for study entry. * Evidence of disease progression by rising PSA or * Soft tissue progression per RECIST 1.1 or * Evidence of disease progression by observation of 2 new bone lesions since the initiation of last systemic therapy. 6. Metastatic prostate cancer disease, documented by the following imaging • Bone lesions on bone scan (per PCWG3) or by soft tissue disease (per RECIST 1.1) by CT/MRI imaging Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist. 7. Prior treatment with a second-generation androgen inhibitor as follows: * For phase 1b, EITHER Previously untreated with or progressed on a second generation androgen inhibitor (abiraterone, enzalutamide, or apalutamide) OR progressed on a second generation inhibitor (inhibitor (abiraterone, enzalutamide, or apalutamide) * For phase 2 randomized component (i.e, enzalutamide- containing treatment arms) of the study, previously progressed on abiraterone. Exclusion Criteria: 1. Known symptomatic brain metastases 2. Treatment with any of the following for prostate cancer within the indicated timeframe prior to day 1 of starting study treatment: * First generation: AR antagonists (eg, bicalutamide, nilutamide, flutamide) within 4 weeks. * 5-alpha-reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol), or progesterones within 2 weeks. * Chemotherapy (except as permitted in inclusion criteria #10) within 3 weeks. * Prior radionuclide therapy within 4 weeks. * Another interventional product or standard agent in a clinical study within 28 days prior to the first planned dose of Tazemetostat * For phase 2 subjects to be randomized to one of the enzalutamide treatment arms only, prior treatment with the second-generation androgen antagonist including enzalutamide, apalutamide, darolutamide, and proxalutamide, etc. 3. Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment 4. Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic castration resistant prostate cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer Metastatic prostate cancer

Contacts and locations

Locations

  • Academisch Ziekenhuis Groeninge Campus Kennedylaan

    Kortrijk, West Vlaanderen, Belgium

  • Associated Medical Professionals of NY, PLLC - Urology

    Syracuse, New York, 13210, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Clinica Universidad de Navarra

    Pamplona, Spain

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Genesis Healthcare Partners

    San Diego, California, 92123, United States

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952, United States

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera, Cadiz, Spain

  • Hospital de la Santa Creu i. Sant Pau

    Barcelona, Spain

  • Hospital del Mar Parc de Salut Mar

    Barcelona, Spain

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Montefiore Einstein Center for Cancer Care

    The Bronx, New York, 10461, United States

  • SCRI - Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37404, United States

  • SCRI - Tennessee Oncology Nashville

    Nashville, Tennessee, 37203, United States

  • The Urology Center Of Colorado

    Denver, Colorado, 80211, United States

  • University of Pittsburgh Medical Center - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Urology Associates P.C.

    Hendersonville, Tennessee, 37075, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • XCancer - Northwest Oncology and Hematology

    Rolling Meadows, Illinois, 60008, United States

  • XCancer - Tennesee Cancer Specialists

    Knoxville, Tennessee, 37909, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.