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

New drug cocktail aims to tackle Hard-to-Treat prostate cancer

NCT ID NCT07181161

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 01, 2026 · Updated 5 times

Summary

This study tests a new drug called AZD0516, given alone or with other cancer drugs, in people with metastatic prostate cancer that has spread. The main goals are to check safety, find the best dose, and see early signs of tumor control. About 177 participants will take part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD0516 (given by IV) and AZD9574 (taken by mouth)
What this could lead to
If successful, this could point toward a new treatment option for metastatic prostate cancer that is resistant to current therapies.
What could go wrong
This is an early-phase trial (Phase 1/2a) focused on safety and dosing, so it is too soon to know if the drug will work. Side effects are unknown, and many early cancer drugs do not advance to later trials.

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

About 283 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

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 to 130 years

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.

Main Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic adenocarcinoma of the prostate. Focal high grade neuroendocrine features are permitted. * Measurable PSA ≥ 1 μg/L (≥ 1 ng/mL). * Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) within ≤ 28 days before treatment allocation. Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) modulator for participants who have not undergone bilateral orchiectomy must be initiated at least 2 weeks prior to consent and must continue throughout the study. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1. * Adequate organ and marrow function in the absence of blood transfusion or growth factor support (within 21 days prior to the scheduled first dose of study intervention). * Provision of baseline archival or newly obtained formalin-fixed paraffin-embedded (FFPE) tumour sample is mandatory. * Documented current evidence of metastatic prostate cancer * Life expectancy of at least 12 weeks in the opinion of the investigator * Documented mCRPC progression at screening as assessed by the investigator with at least one of the following criteria: 1. PSA progression defined by a minimum of 3 rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the screening visit should be ≥ 1 μg/L (1 ng/mL). 2. Radiographic disease progression in soft tissue based on response evaluation criteria in solid tumors (RECIST) v1.1 criteria with or without PSA progression as per prostate cancer working group 3 (PCWG3). 3. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on a bone scan as per PCWG3 with or without PSA progression. Main Exclusion Criteria: * Cancer related spinal cord compression, or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to study enrolment. * History of leptomeningeal carcinomatosis. * Unresolved toxicities of Grade ≥ 2 (National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy). * Uncontrolled intercurrent illness within the last 12 months. * Cardiovascular disorder (History of arrhythmia, uncontrolled hypertension, symptomatic hypotension, history of brain perfusion problems, symptomatic heart failure, prior or current cardiomyopathy, severe valvular heart disease) * History of malignancy * History of non-infectious interstitial lung disease (ILD)/pneumonitis * Active infection exclusions, including tuberculosis and infections with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV). * Any known predisposition to bleeding * Clinically severe pulmonary compromise * Participants with Myelodysplastic syndrome (MDS)/Acute Myeloid Leukemia (AML) or with features suggestive of MDS/AML. * Previous treatment with a STEAP2 targeting modality, chemotherapeutic agent that inhibits topoisomerase activity or metabolic enzymes.

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 prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    47 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Fayetteville, Arkansas, 72703, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90095, United States

  • Research Site

    SUSPENDED

    Towson, Maryland, 21204, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Research Site

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Research Site

    SUSPENDED

    Buffalo, New York, 14263, United States

  • Research Site

    RECRUITING

    New York, New York, 10065, United States

  • Research Site

    RECRUITING

    Providence, Rhode Island, 02906, United States

  • Research Site

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    NOT_YET_RECRUITING

    Barretos, 14784-400, Brazil

  • Research Site

    NOT_YET_RECRUITING

    Porto Alegre, 90035-001, Brazil

  • Research Site

    NOT_YET_RECRUITING

    São Paulo, 01401-002, Brazil

  • Research Site

    NOT_YET_RECRUITING

    Changsha, 410013, China

  • Research Site

    NOT_YET_RECRUITING

    Chengdu, 610041, China

  • Research Site

    NOT_YET_RECRUITING

    Wuhan, 430022, China

  • Research Site

    WITHDRAWN

    Lyon, 69008, France

  • Research Site

    WITHDRAWN

    Montpellier, 34298, France

  • Research Site

    WITHDRAWN

    Saint-Herblain, 44805, France

  • Research Site

    WITHDRAWN

    Suresnes, 92151, France

  • Research Site

    WITHDRAWN

    Villejuif, 94805, France

  • Research Site

    NOT_YET_RECRUITING

    Milan, 20132, Italy

  • Research Site

    NOT_YET_RECRUITING

    Milan, 20133, Italy

  • Research Site

    NOT_YET_RECRUITING

    Milan, 20141, Italy

  • Research Site

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • Research Site

    NOT_YET_RECRUITING

    Roma, 00168, Italy

  • Research Site

    NOT_YET_RECRUITING

    Rozzano, 20089, Italy

  • Research Site

    RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    NOT_YET_RECRUITING

    Kashiwa, 277-8577, Japan

  • Research Site

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Research Site

    NOT_YET_RECRUITING

    Koszalin, 75-581, Poland

  • Research Site

    NOT_YET_RECRUITING

    Piotrkow Trybunalski, 97-300, Poland

  • Research Site

    NOT_YET_RECRUITING

    Przemyśl, 37-700, Poland

  • Research Site

    NOT_YET_RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 06591, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Seoul, 5505, South Korea

  • Research Site

    RECRUITING

    Barcelona, 08035, Spain

  • Research Site

    NOT_YET_RECRUITING

    Barcelona, 08036, Spain

  • Research Site

    NOT_YET_RECRUITING

    Barcelona, 08041, Spain

  • Research Site

    NOT_YET_RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Research Site

    RECRUITING

    Madrid, 28027, Spain

  • Research Site

    RECRUITING

    Pamplona, 31005, Spain

  • Research Site

    NOT_YET_RECRUITING

    Santander, 39008, Spain

  • Research Site

    NOT_YET_RECRUITING

    Valencia, 46009, Spain

  • Research Site

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Research Site

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Research Site

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Research Site

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

More trials for these conditions

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