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Radioactive therapy shows promise for tough prostate cancer

NCT ID NCT05413850

Disease control Sponsor: Blue Earth Therapeutics Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new radioactive drug (lutetium rhPSMA-10.1) in men with advanced prostate cancer that has spread and no longer responds to hormone therapy. The goal is to find the safest and most effective dose, and to see if it can shrink tumors or lower PSA levels. About 82 men will take part in this early-phase trial across multiple centers.

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 82 people

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

Started

Jul 2022

Expected to finish

Mar 2028

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.

Inclusion Criteria: 1. Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate. 2. Serum testosterone levels \<50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration. 3. Presence of disease target or non target lesions (per RECIST v1.1) on CT/MRI and/or presence of disease on full body 99mTc bone scan performed within 28 days of screening. 4. Positive disease expression of PSMA as confirmed on PSMA PET/CT scan. 5. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of study treatment (except for Luteinising Hormone-releasing Hormone or GnRH). 6. Resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤1 (except for chemotherapy induced alopecia and grade 2 peripheral neuropathy or grade 2 urinary frequency which are allowed). 7. Prior major surgery must be at least 12 weeks prior to study entry. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months. 9. Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline. 10. Adequate contraception for patients and their partners. 11. For Phase 1 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide) and at least 1 course (but no more than 2 courses) of taxane-based chemotherapy. For Phase 2 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide, apalutamide, darolutamide), but have not received previous taxane-based chemotherapy for the treatment of mCRPC. Exclusion Criteria: 1. Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents. 2. Presence of significant PSMA-negative disease on ceCT/MRI scan 3. Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan). 4. Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression. 5. Known history of haematological malignancy. 6. Known history of central nervous system (CNS) metastases. 7. Histological findings consistent with neuroendocrine phenotype of prostate cancer. 8. Known history of other solid malignancy that may reduce life expectancy and/or may interfere with disease assessment. 9. Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent/nephrostomy. 10. Any uncontrolled significant medical, psychiatric, or surgical condition or laboratory finding that would pose a risk to subject safety or interfere with study participation or interpretation of individual subject results. 11. Ongoing treatment with bisphosphonates for bone-targeted therapy. 12. Severe urinary incontinence that would preclude safe disposal of radioactive urine. 13. Single kidney or renal transplant or any concomitant nephrotoxic therapy that might put the subject at high risk of renal toxicity during the study in the judgement of the investigator. 14. Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening. 15. Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys. 16. Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation. 17. Subjects with bilateral hip replacements or any significant metallic implants or objects, that may affect image quality and/or dosimetry calculations. 18. Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical study. 19. Participation in other studies involving IMP(s) within 28 days or 5 half-lives (whichever is longer) prior to study entry and/or during study participation. 20. Any history of clinically significant parenchymal lung disease e.g. interstitial lung disease or bullous emphysema. 21. Any history of prior thoracic external beam radiotherapy. 22. Presence of abnormal PSMA PET uptake in the lung parenchyma above expected physiological levels, as determined by local assessment.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer prostate disorder prostate neoplasm Urogenital Neoplasms

As listed by the trial registrant

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

MCRPC Metastatic castration resistant prostate cancer Prostate cancer Prostatic diseases Prostatic neoplasms Urogenital neoplasms

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites in 5 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beatson West of Scotland Cancer Center

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Biogenix Molecular LLC

    RECRUITING

    Miami, Florida, 33165, United States

  • Bristol Hematology and Oncology Center

    RECRUITING

    Bristol, BS2 8ED, United Kingdom

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Hospital Rechts der Isar

    RECRUITING

    Munich, Germany

  • James Cook University Hospital

    RECRUITING

    Middlesbrough, TS4 3BW, United Kingdom

  • Meander Medisch Centrum

    RECRUITING

    Amersfoort, Netherlands

  • NovaCure Health

    RECRUITING

    Miami, Florida, 33176, United States

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, United Kingdom

  • Radboud UMC

    RECRUITING

    Nijmegen, Gelderland, 6525GA, Netherlands

  • Saint Luc University Hospital

    RECRUITING

    Brussels, 1200, Belgium

  • St Bartholomew's Hospital

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • University Hospital Aachen

    RECRUITING

    Aachen, Germany

  • University Hospital Essen

    RECRUITING

    Essen, Germany

  • University Hospital Ghent

    RECRUITING

    Ghent, 9000, Belgium

  • University Hospital Leuven

    RECRUITING

    Leuven, Belgium

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, Germany

  • Weill Cornell Medicine - New York - Presbyterian Hospital

    COMPLETED

    New York, New York, 10065, United States

  • Weston Park

    RECRUITING

    Sheffield, United Kingdom

  • XCancer Omaha / Urology Cancer Center

    RECRUITING

    Omaha, Nebraska, 68130, United States

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