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177Lu-Rhpsma-10.1

Clinical trials are studying 177Lu-Rhpsma-10.1 in men with advanced prostate cancer, especially metastatic castration-resistant prostate cancer. These studies aim to assess safety, tolerability, dosing, and anti-tumor effects, and one trial compares it with another PSMA-targeted treatment.

Table of Contents

Trial overview

Clinical trials of 177Lu-Rhpsma-10.1 are studying men with advanced prostate cancer, mainly metastatic castration-resistant prostate cancer (mCRPC), which means the cancer has spread and is no longer well controlled by hormone-lowering treatment.[1][2]

Two interventional studies are listed: one completed Phase 1 study and one authorised study that includes Phase 1 and Phase 2 parts.[1][2]

Who is being studied

The trials focus on men with advanced prostate cancer, especially those with PSMA-positive disease, which means the cancer shows a marker called PSMA that can help identify the right study group.[1]

One study includes patients with PSMA-positive non-curative metastatic castration-resistant prostate cancer, while the other study includes men with metastatic castration-resistant prostate cancer (mCRPC).[1][2]

Trial phases and study goals

Both studies are early clinical trials, and one of them also moves into Phase 2.[1][2] Phase 1 usually focuses on safety, tolerability, and the study of the right treatment regimen, which means the way the treatment is given.[2]

In the completed Phase 1 study, the main goal was to compare the therapeutic index of 177Lu-Rhpsma-10.1 with lutetium (177Lu) vipivotide tetraxetan (Pluvicto®).[1] In the authorised study, Phase 1 aimed to find the recommended Phase 2 dose regimen by checking safety and tolerability, and Phase 2 aimed to evaluate efficacy, which means whether the treatment shows signs of helping against the cancer.[2]

Main outcomes being measured

The completed study measured the ratio of tumor to kidney absorbed dose, which is a way to compare how much treatment reaches the cancer versus the kidney.[1] This is called the therapeutic index.[1]

The authorised study measured dose-limiting toxicities (serious side effects that can limit the dose), treatment-emergent adverse events (health problems that appear or worsen during treatment), and the number of patients with an anti-tumor response defined as a PSA drop of at least 50% by the end of treatment.[2]

Summary of the trials

One study is already completed and enrolled 24 people, while the other is authorised and planned to enroll 112 people.[1][2]

Together, these trials are designed to learn whether 177Lu-Rhpsma-10.1 is safe enough for further study and whether it may help control advanced prostate cancer.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT06516510 Phase 1 PSMA-positive non-curative metastatic castration-resistant prostate cancer Completed 24
NCT05413850 Phase 1 / Phase 2 Metastatic castration-resistant prostate cancer (mCRPC) Authorised 112

FAQ

  • What is being studied in the 177Lu-Rhpsma-10.1 trials? The trials are studying 177Lu-Rhpsma-10.1 in men with advanced prostate cancer. Researchers want to see how safe it is, how well it is tolerated, and whether it helps control the cancer.
  • Who can join these trials? The main study population is men with metastatic castration-resistant prostate cancer, also called mCRPC. One trial also focused on PSMA-positive non-curative metastatic prostate cancer.
  • What phases are the trials in? Both trials are in Phase 1, and one of them also includes Phase 2. Phase 1 usually looks at safety and the best dose or regimen, while Phase 2 looks more closely at how well the treatment works.
  • What results are the trials measuring? One trial measures dose balance between tumor and kidney, called the therapeutic index. Another trial measures dose-limiting toxicities, treatment-emergent adverse events, and PSA response, which means a drop in prostate-specific antigen by at least 50%.
  • How many people are in the studies? One completed study enrolled 24 people, and the other authorized study planned to enroll 112 people. These numbers help show the size of the research.

Ongoing Clinical Trials on 177Lu-Rhpsma-10.1

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

    Recruiting

    1 1
    Investigated drugs:
    Belgium Germany The Netherlands

  • Study Comparing Lutetium (177Lu) rhPSMA-10.1 and Lutetium (177Lu) Vipivotide Tetraxetan for Patients with Advanced Prostate Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    France Germany The Netherlands Spain

Glossary

  • Metastatic prostate cancer: Prostate cancer that has spread from the prostate to other parts of the body.
  • Castration-resistant prostate cancer (CRPC): Prostate cancer that keeps growing even when male hormone levels are very low.
  • Metastatic castration-resistant prostate cancer (mCRPC): A form of prostate cancer that has spread and no longer responds well to hormone-lowering treatment.
  • PSMA-positive: Cancer cells that show a marker called PSMA, which helps researchers identify the right patients for the study.
  • Phase 1: An early study phase that mainly checks safety, tolerability, and how the treatment should be given.
  • Phase 2: A study phase that looks more closely at whether the treatment shows signs of working.
  • Dose-limiting toxicities (DLTs): Side effects that are serious enough to limit the dose that can be used safely.
  • Treatment-emergent adverse events (TEAEs): Medical problems that appear or get worse after treatment starts.
  • Prostate-specific antigen (PSA): A protein made by the prostate. In prostate cancer studies, a drop in PSA can be a sign that treatment is helping.
  • Therapeutic index: A way to compare how much treatment reaches the tumor versus nearby organs, such as the kidney.

References