Not recruitingRare disease

Study on the Safety and Feasibility of PSMA-T4 for Prostate Cancer Patients

Fast replyInvestigationalNo 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 prostate cancer, a disease that affects the prostate gland in men. The study will use a treatment called 99mTc-PSMA-T4, which is a special type of preparation used in medical imaging. This treatment is designed to help doctors see the cancer more clearly and plan the best course of action for treatment. The purpose of the study is to evaluate how well this treatment works and how safe it is for patients.

Participants in the study will receive the 99mTc-PSMA-T4 treatment through an injection. The study will monitor how the treatment helps in diagnosing and planning treatment for prostate cancer and its spread to other parts of the body, known as metastases. The study will also keep track of any side effects that might occur after the treatment is given. The goal is to see if this method can accurately detect cancerous areas and help in making treatment decisions.

The study will take place over a period of time, during which participants will be closely observed to ensure their safety and to gather information on the effectiveness of the treatment. The results will help determine if 99mTc-PSMA-T4 is a feasible and safe option for diagnosing and planning treatment for prostate cancer. This research could potentially lead to better ways of managing prostate cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent, confirming your willingness to participate.
You must meet specific criteria, such as being 18 years or older, having a prior diagnosis of prostate cancer with a Gleason score above 6, and other conditions based on your cohort.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This may include a prostate biopsy and imaging tests like mpMRI and CT scans, depending on your cohort.
Step 3
Medication administration
You will receive an intravenous injection of 99mTc-PSMA-T4, a radiopharmaceutical used for diagnosing and planning treatment for prostate cancer.
The administration of this medication is part of the study to evaluate its feasibility and safety.
Step 4
Monitoring and follow-up
After receiving the medication, you will be monitored for any adverse events or side effects for a period of 24 to 48 hours.
This monitoring is crucial to ensure your safety and to gather data on the medication's effects.
Step 5
Evaluation of results
The study will evaluate the effectiveness of the diagnostic method by checking if it meets the criteria of sensitivity and specificity in detecting prostate cancer lesions.
Your participation will help determine the positive and negative predictive values of the method.

Who can join the trial?

16 criteria

Must be 18 years of age or older.
Must have a PS ECOG score of less than 2. This is a scale that measures how well you can perform daily activities.
Must have a prior diagnosis of any type of prostate cancer with a Gleason score above 6. The Gleason score is a way to grade prostate cancer based on its appearance under a microscope.
Must have a confirmatory prostate biopsy within 12 weeks before joining the study, only for certain groups (cohorts A and B).
Must have a pelvic mpMRI prostate scan with a PIRADS 2.1 score within 12 weeks before joining the study, only for certain groups (cohorts A and B). This is a type of imaging test to look at the prostate.
Must be willing to participate in the study and provide written informed consent.
For Cohort A:
- Must have intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer.
- Must have a greater than 10% chance of lymph node involvement, assessed using a specific tool called the Memorial Sloan Kettering nomogram.
- Must have a CT scan of the chest, abdomen, and pelvis, and a bone scan within 12 weeks before joining the study if in the unfavorable risk prostate cancer subgroup.
- Must not have had any prior treatment for prostate cancer.
- For Cohort B:
  - Must have high or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer.
  - Must have a CT scan of the chest, abdomen, and pelvis, and a bone scan within 12 weeks before joining the study if in the unfavorable risk prostate cancer subgroup.
  - Must not have had any prior treatment for prostate cancer.
  - For Cohort C:
    
    Must have biochemical failure after radical prostatectomy, which means the PSA (a protein produced by the prostate) does not fall to undetectable levels or becomes detectable again after surgery.
    Must have biochemical failure after definitive radiotherapy based on specific guidelines called the Phoenix Consensus.
    Must have radiographic evidence of metastatic disease without PSA persistence/recurrence or clinical symptoms suggesting distant metastases.

Who cannot join the trial?

2 criteria

Patients who are not male cannot participate in the study.
Patients who are part of a vulnerable population cannot participate in the study. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu
Verified
Wroclaw, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Responsive
Lodz, Poland

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Investigated drugs

99mTc-PSMA-T4 is a special type of medication used in the diagnosis and treatment planning for prostate cancer. It is administered through an injection into the bloodstream. This medication helps doctors see where the cancer is located in the body by using a small amount of radioactive material. The radioactive part of the medication attaches to prostate cancer cells, making them visible on a special camera. This helps doctors understand how far the cancer has spread and plan the best treatment for the patient. The main goal of using this medication in the trial is to ensure it is safe and effective for patients with prostate cancer.

What is already known about the treatment

99mTc-PSMA-T4 – This medication is administered intravenously, meaning it is injected directly into the bloodstream. It is currently being studied in clinical trials to assess its safety and effectiveness in diagnosing and planning treatment for prostate cancer. The main use of 99mTc-PSMA-T4 is to help doctors see prostate cancer and its spread more clearly, which can improve treatment decisions. At the molecular level, it works by attaching to a specific protein found on prostate cancer cells, allowing it to be detected by imaging techniques. It is classified as a radiopharmaceutical, which is a type of drug that contains a small amount of radioactive material used for diagnosis or treatment.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in males that produces seminal fluid. As the disease progresses, it may spread to nearby tissues or other parts of the body, such as bones and lymph nodes. Early stages often have no symptoms, but as it advances, symptoms like difficulty urinating, blood in urine, or pelvic discomfort may occur. The progression can vary, with some forms growing slowly and others more aggressively. Monitoring and understanding the disease's progression are crucial for effective management.