#1 Clinical Trials Search in Europe

Gallium (68Ga) Psma-R2

Clinical trials are currently investigating the use of Gallium (68Ga) PSMA-R2, a radioactive drug, in patients with advanced prostate cancer. This article provides an overview of these trials, focusing on their objectives, eligibility criteria, and potential benefits for patients with metastatic castration-resistant prostate cancer (mCRPC).

Table of Contents

What is GALLIUM (68GA) PSMA-R2?

GALLIUM (68GA) PSMA-R2, also known as AAA502, is an innovative radiopharmaceutical drug being studied for the treatment of advanced prostate cancer[1]. It belongs to a class of drugs called radioligand therapies, which combine a radioactive element with a molecule that targets specific cancer cells.

How does it work?

This drug works by targeting a protein called Prostate-Specific Membrane Antigen (PSMA), which is often found in high levels on prostate cancer cells. The PSMA-R2 part of the drug acts like a “homing device,” guiding the radioactive gallium-68 directly to the cancer cells. Once there, the radiation can help to destroy the cancer cells while minimizing damage to healthy tissue[1].

What conditions does it treat?

GALLIUM (68GA) PSMA-R2 is being studied for the treatment of PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)[1]. This is an advanced form of prostate cancer that:

  • Has spread to other parts of the body (metastatic)
  • Continues to grow even when the body’s testosterone levels are reduced to very low levels (castration-resistant)
  • Has high levels of the PSMA protein on the cancer cells (PSMA-positive)

The drug is being tested in patients who have and have not previously received another type of radioligand therapy called 177Lu-PSMA[1].

Clinical Trial Information

GALLIUM (68GA) PSMA-R2 is currently being studied in a clinical trial called “SatisfACtion”[1]. This is a Phase I/II trial, which means it’s designed to:

  • Test the safety of the drug
  • Find the right dose
  • See how well it works in treating the cancer

The trial is “open-label,” meaning both the patients and the doctors know which treatment is being given[1].

Eligibility Criteria

To participate in this trial, patients must meet certain criteria[1]. Some key requirements include:

  • Being 18 years or older
  • Having confirmed prostate cancer that has spread and is resistant to hormone therapy
  • Having cancer that is visible on certain types of scans and is PSMA-positive
  • Having adequate organ function

There are also factors that may disqualify a person from participating, such as certain heart conditions or other serious medical issues[1].

Potential Benefits and Risks

While the potential benefits of GALLIUM (68GA) PSMA-R2 are still being studied, the hope is that it will effectively target and destroy cancer cells in patients with advanced prostate cancer[1].

As with any medical treatment, there may be risks and side effects. The clinical trial is designed to carefully monitor patients for any adverse effects. Some areas of particular concern include effects on bone marrow, liver function, and kidney function[1].

Administration and Dosage

GALLIUM (68GA) PSMA-R2 is given intravenously, which means it’s injected directly into a vein[1]. The exact dosage and frequency of treatment are part of what’s being determined in the clinical trial.

It’s important to note that this drug is still in the investigational stage. If you think you might be eligible for this trial or want to learn more about treatment options for advanced prostate cancer, it’s crucial to discuss this with your healthcare provider.

Aspect Details
Study Type Phase I/II, open-label, multi-center study
Drug 225Ac-PSMA-R2 (related to Gallium (68Ga) PSMA-R2)
Target Population Men with PSMA-positive mCRPC, with or without prior 177Lu-PSMA therapy
Primary Objectives Evaluate safety, tolerability, and anti-tumor activity
Key Eligibility Criteria Adult men, confirmed mCRPC, PSMA-positive disease, adequate organ function
Main Exclusion Criteria Recent use of certain radiopharmaceuticals, CNS metastases, severe urinary issues
Primary Endpoints Incidence of adverse events, overall response rate
Secondary Endpoints Progression-free survival, overall survival, quality of life measures

FAQ

  • What is Gallium (68Ga) PSMA-R2? Gallium (68Ga) PSMA-R2 is a radioactive drug used in diagnostic imaging for prostate cancer. It targets a specific protein called PSMA, which is often found in high levels on prostate cancer cells.
  • What type of prostate cancer is being studied in these trials? The trials are focusing on PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), which is an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy.
  • What are the main objectives of these clinical trials? The main objectives are to evaluate the safety, tolerability, and effectiveness of a treatment called 225Ac-PSMA-R2 in patients with mCRPC, both in those who have previously received 177Lu-PSMA therapy and those who have not.
  • Who is eligible to participate in these trials? Eligible participants are adult men with confirmed mCRPC, adequate organ function, and evidence of PSMA-positive disease. They must have progressing cancer despite previous treatments and meet specific criteria regarding their overall health and previous therapies.
  • What are some potential benefits of participating in these trials? Participants may gain access to a new treatment option for advanced prostate cancer. The trials aim to assess the anti-tumor activity of the drug, which could potentially slow down cancer progression or improve symptoms. Additionally, participants contribute to the advancement of cancer research.

Ongoing Clinical Trials on Gallium (68Ga) Psma-R2

  • Study of [225Ac]Ac-PSMA-R2 for Men with Advanced Prostate Cancer Previously Treated or Not with 177Lu-PSMA Therapy

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France

Glossary

  • mCRPC: Metastatic Castration-Resistant Prostate Cancer: An advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy that lowers testosterone.
  • PSMA: Prostate-Specific Membrane Antigen: A protein found on the surface of prostate cancer cells, often in higher amounts in more aggressive cancers.
  • Radioligand Therapy (RLT): A type of cancer treatment that uses radioactive substances attached to drugs that specifically target cancer cells.
  • 68Ga-PSMA-R11 PET/CT: A type of imaging scan that uses a radioactive tracer to detect prostate cancer cells throughout the body.
  • Dose Escalation: A phase in clinical trials where the dose of a drug is gradually increased to find the optimal safe dose.
  • Dose Expansion: A phase in clinical trials where the established dose from the escalation phase is given to a larger group of patients to further evaluate its effects.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.

References

  1. http://clinicaltrials.eu/trial/study-of-225acac-psma-r2-for-men-with-advanced-prostate-cancer-previously-treated-or-not-with-177lu-psma-therapy/