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New hope for advanced prostate cancer: drug combo trial launches

NCT ID NCT07590934

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study is testing two experimental drugs (AZD9574 and AZD2265) together in people with metastatic prostate cancer that has spread beyond the prostate. The goal is to see if the combination is safe and can shrink tumors or lower PSA levels. About 152 adults whose cancer has not responded to standard treatments will take part. The trial is not yet recruiting.

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 152 people

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

Started

Jun 2026

Expected to finish

Sep 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 99 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.

Inclusion Criteria: 1. Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell). 2. Minimum life expectancy of 3 months or more. 3. Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration. 4. PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease. 5. Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate. 6. Must have one or more unresectable metastatic lesions. 7. Must have had prior orchiectomy and/or ongoing androgen deprivation therapy, and a castrate level of serum testosterone (\<50ng/dL or \<l.7nmol/L). 8. Progressive metastatic castration-resistant prostate cancer (mCRPC) following the most recent treatment at time of study entry. 9. Adequate organ and marrow function. 10. Non sterilised participants who are sexually active with a partner of childbearing potential must use a condom (plus spermicide, if available), must refrain from fathering a child, freezing or donating sperm, and it is recommended for the partner to also use a highly effective contraceptive method. Inclusion Criteria for Sub study 1: 1. Must have received a single line of ARPI, such as enzalutamide, darolutamide, apalutamide or abiraterone acetate. Participants who were exposed to more than one ARPI due to toxicity or intolerance (not due to disease progression) are eligible. 2. PSMA positive mCRPC by computed tomography positron emission tomography, obtained with PSMA ligand defined as at least 1 PSMA positive metastatic lesion with tracer uptake greater than liver, and no PSMA negative lesions. All measurable or intraprostatic lesions must be PSMA positive. 3. Capable of self-administering oral formulations. Exclusion Criteria: 1. Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous). 2. Known, unresolved urinary tract obstruction. 3. Participants with a history of central nervous system metastases. 4. Symptomatic malignant spinal cord compression or findings indicative of impending cord compression. 5. Participants with a history of leptomeningeal carcinomatosis. 6. Previous or concurrent cancer distinct from the cancer under investigation in primary site or histology . 7. Concurrent serious medical conditions. 8. Previous history of interstitial lung disease or non-infectious pneumonitis. 9. Participants with a history or clinical/laboratory features suggestive of myelodysplastic syndrome or acute myeloid leukaemia. 10. Persistent toxicities caused by previous therapy. 11. Participants unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with absorption. 12. Active infection, including tuberculosis, hepatitis C virus, and hepatitis B virus infection. 13. Known hypersensitivity to study intervention or any of their excipients. Exclusion Criteria for Sub study 1: 1. History of uncontrolled seizures or requirement for \>2 antiepileptic drugs. 2. History of severe brain injury or stroke. 3. Skeletal metastases demonstrating a superscan appearance on bone scan. 4. Participants have received prior therapy with palacaparib (AZD9574) or more than 1 prior line of any other Poly-ADP-ribose polymerase inhibitor (PARPi)-based regimen (either as a treatment or as maintenance).

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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

    36 sites in 7 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

    NOT_YET_RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    NOT_YET_RECRUITING

    Encino, California, 91436, United States

  • Research Site

    RECRUITING

    South Pasadena, California, 91030, United States

  • Research Site

    RECRUITING

    Miami, Florida, 33165, United States

  • Research Site

    NOT_YET_RECRUITING

    Tampa, Florida, 33612, United States

  • Research Site

    NOT_YET_RECRUITING

    Metairie, Louisiana, 70006, United States

  • Research Site

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Research Site

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68130, United States

  • Research Site

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

  • Research Site

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Research Site

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    NOT_YET_RECRUITING

    North Adelaide, 5000, Australia

  • Research Site

    NOT_YET_RECRUITING

    Essen, 45147, Germany

  • Research Site

    NOT_YET_RECRUITING

    Jena, 07747, Germany

  • Research Site

    NOT_YET_RECRUITING

    Rostock, 18057, Germany

  • Research Site

    NOT_YET_RECRUITING

    Tübingen, 72076, Germany

  • Research Site

    NOT_YET_RECRUITING

    Bergamo, 24127, Italy

  • Research Site

    NOT_YET_RECRUITING

    Meldola, 47014, Italy

  • Research Site

    NOT_YET_RECRUITING

    Milan, 20133, Italy

  • Research Site

    NOT_YET_RECRUITING

    Milan, 20141, Italy

  • Research Site

    NOT_YET_RECRUITING

    Roma, 00168, Italy

  • Research Site

    NOT_YET_RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Seoul, 06591, South Korea

  • Research Site

    WITHDRAWN

    Seoul, 5505, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Barcelona, 08028, Spain

  • Research Site

    NOT_YET_RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Research Site

    NOT_YET_RECRUITING

    Madrid, 28031, Spain

  • Research Site

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • Research Site

    NOT_YET_RECRUITING

    Pamplona, 31008, Spain

  • Research Site

    NOT_YET_RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Fulham, SW3 6JJ, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Guildford, CU2 7XX, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    London, WC1E 6DB, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Oxford, OX3 7LE, United Kingdom

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