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Promising new radiation therapy targets Hard-to-Treat prostate cancer

NCT ID NCT06879041

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage study tests a new drug (AZD2284) that delivers radiation directly to prostate cancer cells. It is for men whose cancer has spread and no longer responds to hormone therapy. The main goals are to check safety and find the right dose, while also measuring how well it shrinks tumors and controls the disease.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 136 people

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

Started

Mar 2025

Expected to finish

Apr 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 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.

Main Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Histologically confirmed diagnosis of adenocarcinoma of the prostate without strong clinical suspicion of majority neuroendocrine differentiation. * Must have had prior bilateral orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * At least one metastatic lesion present on baseline Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or bone scan obtained ≤ 28 days prior to the first dose of Investigational Medicinal Product (IMP). Participants may have non-measurable lesions including bone only metastases. * Adequate organ function * Part A only: Metastatic prostate cancer considered to be stable or progressing metastatic castration resistant prostate cancer (mCRPC). * Part B only: Progressing mCRPC defined as meeting at least one of following documented criteria - 1. Serum/plasma PSA progression 2. Soft-tissue progression 3. Progression of bone disease * Part B Dose Escalation: Previously treated with at least 2 prior lines of systemic anti-cancer therapy for mCRPC. Prior lines must include: 1. At least 1 androgen receptor pathway inhibitor (ARPI) 2. A poly (adp-ribose) polymerase (PARP) inhibitor for participants with known BRCA mutation 3. A checkpoint inhibitor for participants with known microsatellite instability-high (MSI-H), deficient mismatch pair (dMMR), or tumor mutational burden (TMB) ≥ 10 mut/Mb * Part B Dose Expansion: Previously treated with at least 1 prior line of systemic anti-cancer therapy for mCRPC. Prior lines must include: 1. At least 1 ARPI 2. A PARP inhibitor for participants with known BRCA mutation per local practice, unless ineligible per Investigator decision. 3. A checkpoint inhibitor for participants with known MSI-H, dMMR, or TMB ≥ 10 mut/Mb. 4. No previous cytotoxic chemotherapy for CRPC. Taxanes for metastatic hormone sensitive prostate cancer (mHSPC) is acceptable if the last cycle Day 1 was \> 12 months before first study treatment. 5. Previous treatment with prostate specific membrane antigen radioligand therapy (PSMA-RLT) or Radium-223 is allowed but not required. Participants who have had prior radiation therapy, including therapeutic radiopharmaceuticals, external bean radiation therapy (EBRT), and/or brachytherapy are eligible, subject to satisfying all other inclusion/exclusion criteria. Therapeutic radiopharmaceuticals will be considered a prior line of systemic therapy. Main Exclusion Criteria: * Treatment with any radiopharmaceutical within 6 weeks of the first dose of Investigational Medicinal Product (IMP). * Radiation therapy (RT) or external beam radiation therapy (EBRT) within 28 days prior to the first dose and all RT-related events have not recovered to Grade ≤ 1. * Administration of any systemic cytotoxic or investigational therapy ≤ 28 days of the first dose of IMP or 5 half-lives, whichever is shorter. * All prior treatment-related adverse events must have resolved to Grade ≤ 1. * Concurrent severe and/or uncontrolled illness not related to cancer and/or social situation that would limit compliance with study requirements. * Known or suspected allergies or contraindications to any of the investigational drugs or any component of the investigational drug formulation. * Clinically relevant proteinuria * Diffuse and intense osseous radiotracer uptake on bone scintigraphy or PSMA imaging characteristic of a superscan. * Chronic corticosteroid use greater than 10 mg prednisone equivalent daily.

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Conditions

The condition(s) this trial relates to.

castration-resistant 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

How to take part

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

  1. The places running it

    15 sites in 3 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

    Palo Alto, California, 94304, United States

  • Research Site

    NOT_YET_RECRUITING

    San Diego, California, 92103, United States

  • Research Site

    RECRUITING

    Miami, Florida, 33165, United States

  • Research Site

    RECRUITING

    Tampa, Florida, 33612, United States

  • Research Site

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Research Site

    NOT_YET_RECRUITING

    Metairie, Louisiana, 70006, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Research Site

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55902, United States

  • Research Site

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Research Site

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Research Site

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Research Site

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Research Site

    RECRUITING

    East Melbourne, 3002, Australia

  • Research Site

    NOT_YET_RECRUITING

    CapeTown, 7925, South Africa

  • Research Site

    WITHDRAWN

    Durban, 4013, South Africa

  • Research Site

    NOT_YET_RECRUITING

    Pretoria, 181, South Africa

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