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Study on the Safety and Effects of Lutetium (177Lu) rhPSMA-10.1 Injection in Men with Advanced Prostate Cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of advanced prostate cancer known as metastatic castration-resistant prostate cancer (mCRPC). The study is investigating the effects of a test drug called Lutetium (177Lu) rhPSMA-10.1 injection. This drug is given as a solution for injection into the veins. The purpose of the study is to evaluate the safety and effects of this treatment in men with this specific type of prostate cancer.

The study will be conducted in two phases. In the first phase, the main goal is to determine the best dose of Lutetium (177Lu) rhPSMA-10.1 injection by assessing its safety and how well it is tolerated by the participants. In the second phase, the focus will be on evaluating how effective the drug is in treating the cancer. Participants will receive the drug through intravenous injections, and their health will be monitored throughout the study to observe any changes or improvements in their condition.

During the study, participants will undergo various tests and scans, including a special type of imaging called PET/CT scan, which helps in detecting cancerous lesions. The study aims to gather information on how the drug affects the cancer and the overall health of the participants. The trial is expected to continue until 2027, with recruitment starting in early 2024. Participants will be closely monitored for any side effects and changes in their cancer status throughout the study period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will provide informed consent, confirming understanding and agreement to participate in the trial.

    Eligibility will be confirmed based on specific criteria, including age, medical history, and current health status.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish baseline health metrics. This includes blood tests, imaging scans, and other necessary evaluations.

    The presence of prostate cancer will be confirmed through diagnostic imaging, such as a PET/CT scan.

  3. Step 3

    Phase 1 treatment

    The first phase involves the administration of Lutetium (177Lu) rhPSMA-10.1 injection through an intravenous route.

    The primary goal is to determine the safe dosage and observe any side effects. This phase will monitor the body's response to the treatment.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring will occur to assess the treatment's impact on cancer progression and overall health.

    Blood tests and imaging scans will be repeated at specified intervals to track changes.

  5. Step 5

    Phase 2 treatment

    In the second phase, the focus shifts to evaluating the effectiveness of the treatment in reducing cancer markers.

    The same medication, Lutetium (177Lu) rhPSMA-10.1 injection, will be used, with adjustments based on findings from phase 1.

  6. Step 6

    Follow-up assessments

    Follow-up assessments will continue to monitor the participant's health and any changes in cancer status.

    These assessments will help determine the long-term effects of the treatment.

  7. Step 7

    End of study

    The study concludes with a final evaluation to summarize the participant's health status and the treatment's impact.

    Participants will receive guidance on any necessary post-study care or monitoring.

Who can join the trial?

22 criteria

  • Male subjects, 18 years of age or older.
  • Willing to provide signed and dated written informed consent before any study-specific procedures.
  • Willing to follow required lifestyle restrictions after receiving the study medication.
  • Confirmed diagnosis of prostate cancer through a tissue sample.
  • Low testosterone levels after surgical or ongoing chemical castration.
  • Presence of disease target or non-target lesions on imaging tests like CT/MRI or a full-body bone scan done within 28 days of screening.
  • Positive disease expression of **PSMA** (a protein found in prostate cancer cells) confirmed on a specific type of scan.
  • At least 28 days or 5 half-lives (whichever is longer) since the last anti-cancer treatment before starting the study treatment, except for certain hormone treatments.
  • Resolution of all previous treatment-related side effects to a mild level, except for hair loss from chemotherapy and certain nerve or urinary issues, which are allowed.
  • At least 12 weeks since any major surgery before entering the study.
  • **ECOG performance status** of 0-2, which means the patient is fully active or has some limitations but can still take care of themselves, with a life expectancy of at least 6 months.
  • Adequate bone marrow reserve and organ function as shown by specific blood tests, including:
    • Platelet count of at least 150,000 per microliter.
    • White blood cell count of at least 3,000 per microliter.
    • Neutrophil count of at least 1,500 per microliter.
    • Hemoglobin level of at least 10 grams per deciliter.
    • Kidney function with a filtration rate of at least 60 mL/min.
    • Total bilirubin less than 1.5 times the upper limit of normal, unless there's a history of Gilbert's disease.
    • Serum albumin of at least 30 grams per liter.
    • AST and ALT (liver enzymes) less than 2 times the upper limit of normal.
    • Male subjects must not father children or donate sperm during the study and for at least 6 months after the last study treatment. They must agree to use effective contraception during this period.
    • Specific criteria for different phases of the study:
      • For both Phase 1 and Phase 2: Subjects must have experienced disease progression after at least one type of hormone therapy and one or two courses of a specific type of chemotherapy.
      • For Phase 2 only: Subjects must have experienced disease progression after at least one type of hormone therapy but have not received previous chemotherapy.

Who cannot join the trial?

4 criteria

  • Patients who do not have metastatic castration-resistant prostate cancer (mCRPC) cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Females cannot participate in this study.
  • Patients who are not male cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate. This means people who might need extra protection or care, like those who cannot make decisions for themselves.
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Investigated drugs

Lutetium (177Lu) rhPSMA-10.1 injection is a treatment being studied for its safety, tolerability, and effectiveness in men with metastatic castrate-resistant prostate cancer. This therapy involves using a radioactive substance, Lutetium-177, which is linked to a molecule that targets prostate-specific membrane antigen (PSMA) found on prostate cancer cells. The goal is for the radioactive component to deliver targeted radiation to the cancer cells, potentially reducing the size of tumors and slowing the progression of the disease.

What is already known about the treatment

Lutetium (177Lu) rhPSMA-10.1 – This medication is administered through an intravenous injection and is currently being studied in clinical trials for its safety, tolerability, and effectiveness. It is primarily being investigated for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The drug works by targeting a specific protein found on prostate cancer cells, delivering radiation directly to the tumor, which helps to destroy cancer cells. It is classified as a radiopharmaceutical, a type of drug that combines a radioactive element with a molecule that targets cancer cells.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer (mCRPC) – This is a type of prostate cancer that continues to progress despite treatments that lower testosterone levels, which are typically used to manage prostate cancer. In this condition, cancer cells have spread beyond the prostate gland to other parts of the body, such as bones or lymph nodes. The disease is characterized by its resistance to hormonal therapy, which is usually effective in controlling prostate cancer. As the cancer advances, it may cause symptoms such as pain, fatigue, and difficulty urinating. The progression of mCRPC can vary, with some patients experiencing rapid advancement while others may have a slower course. The focus of ongoing research is to find effective treatments that can manage the disease and improve quality of life for those affected.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-511537-35-00Protocol codeBET-PSMA-121Estimated enrolment103 patientsSponsorBlue Earth Therapeutics Limited

sourced from the EU Clinical Trials Register and site verification

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