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Phase 1 Study of Terbium (161TB) Zadavotide Guraxetan as Neoadjuvant Treatment in Very High‑Risk Prostate Cancer Patients Eligible for Surgery

Verified siteInvestigationalNo placebo

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What is this trial about?

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

A study is being conducted in people with Prostate cancer that is classified as very high‑risk. The investigational drug, identified as TRP-001, is given by intravenous injection, which means it is delivered directly into a vein. The medication is tested before the main treatment, a concept known as neoadjuvant therapy, meaning it is administered prior to surgery to see if it can improve outcomes.

The purpose of the study is to find the safest and most effective amount of the drug to use before surgery. Participants will receive one or more doses of the medication, followed by a standard surgical procedure called radical prostatectomy (removal of the prostate gland) together with an extended pelvic lymph node dissection (removal of nearby lymph nodes to check for spread). After the treatment, patients are monitored for side effects and for how well the surgery can be performed.

Researchers will look for any serious side effects that stop the dose from being increased, known as dose‑limiting toxicities, and will determine the maximum tolerated dose, the highest dose that can be given without unacceptable problems. They will also record overall safety, how easily the surgery can be completed, and early signs that the cancer is responding, such as changes in blood tests and tissue examined after removal. This early‑stage, phase 1 study helps decide the dose to use in later trials.

The research process

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

Step 1
Confirmation of study participation
After enrollment, the study team confirms that you meet all eligibility criteria and provides written information about the trial procedures.
Step 2
Baseline assessments
You undergo a series of medical examinations, including blood tests, imaging studies, and a physical examination, to document the status of your prostate cancer before any study treatment.
Step 3
First administration of <b>TRP-001</b>
A single intravenous injection of the investigational drug is given. the dose is 11.1 GBq (gigabecquerel), which is measured as the amount of radioactivity in the solution.
The injection is performed in a clinical setting by trained staff, and you are observed for any immediate reactions.
Step 4
Monitoring for dose‑limiting toxicities
After the injection, you are monitored closely for a period defined by the study to identify any dose‑limiting toxicities (side effects that prevent further increase of the dose).
Regular visits, laboratory tests, and symptom checks are scheduled during this evaluation period.
Step 5
Pre‑surgical evaluation
Once the monitoring period is completed and no unacceptable side effects are observed, the study team assesses whether you are ready for surgery.
Additional imaging or lab tests may be performed to confirm that the cancer has not progressed.
Step 6
Radical prostatectomy with extended pelvic lymph node dissection
You undergo the planned surgical removal of the prostate gland (radical prostatectomy) together with removal of lymph nodes in the pelvis (extended pelvic lymph node dissection).
The surgery is performed according to standard clinical practice, and the operative team records the duration of the procedure and any intra‑operative complications.
Step 7
Post‑surgical follow‑up
After recovery from surgery, you attend follow‑up visits to evaluate healing, review pathology results, and monitor any late side effects.
The study collects information on biochemical response, objective tumor response, and pathological response based on the tissue removed during surgery.

Who can join the trial?

12 criteria

Confirmed diagnosis of prostate adenocarcinoma (a type of prostate cancer) with no special forms such as neuroendocrine, small‑cell, or transitional‑cell disease.
Age 18 years or older.
Signed informed consent form showing you understand the study and agree to take part.
If you are sexually active, you must agree to use condoms or another reliable birth‑control method during the study and for at least three months after the last treatment.
Must be classified as very high‑risk according to the National Comprehensive Cancer Network (NCCN) guidelines, which are widely used recommendations for cancer care.
Must have a positive result on a PSMA‑avid PET/CT scan, meaning the tumor shows at least twice the normal background activity (PRIMARY score 3‑5). PSMA is a molecule that many prostate cancers have, and PET/CT is an imaging test that shows where it is located.
No evidence of cancer spread to distant sites (M0 staging) as confirmed by the same PET/CT scan performed within 28 days before starting treatment.
Planned to undergo a potentially curative radical prostatectomy (surgical removal of the entire prostate, seminal vesicles, and extended pelvic lymph nodes) as decided by your doctor.
Samples of tumor tissue from both the initial prostate biopsy and the later surgery must be available for detailed laboratory review.
Must be treatment‑naïve, meaning you have not received any prior therapy for this prostate cancer.
Must have adequate organ function, defined as no blood transfusion or use of blood‑building medicines (hematopoietic growth factors) within the four weeks before blood testing.
Performance status of ECOG 0‑1 (fully active or able to do light work but not able to carry out strenuous activities).

Who cannot join the trial?

15 criteria

Have already received any treatment for prostate cancer, such as hormone therapy, radiation, chemotherapy, immunotherapy, or experimental drugs.
Have taken or need to take any experimental drug or prohibited medicine within 28 days before the trial starts.
Have significant bladder problems that would make it hard to empty urine that may become radioactive after treatment (this is called voiding dysfunction).
Have a serious heart condition, including severe chest pain (unstable angina), heart attack (myocardial infarction), dangerous heart rhythm problems (arrhythmia), a pacemaker or artificial heart valve, heart bypass surgery (coronary artery bypass) within the last 3 years, severe heart failure (New York Heart Association NYHA class 3 or 4), or uncontrolled high blood pressure (hypertension over 150/100) on more than one recent visit.
Have any other serious medical condition that the doctor believes could make the treatment or required surgery unsafe.
Have an active infection with hepatitis B, hepatitis C, or HIV.
Have had another invasive cancer in the past 2 years, except for certain skin cancers (basal cell carcinoma or squamous cell carcinoma) or non‑muscle invasive bladder cancer that was treated successfully.
Have a history or current diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML).
Have a history of Sjogren disease or any autoimmune disease that needs ongoing immune‑suppressing medication.
Have had major surgery within 4 weeks before joining the study.
Have an uncontrolled or severe infection.
Have a history of head and neck squamous cell carcinoma that was treated with definitive radiation therapy.
Have had a prior stem‑cell transplant (autologous or allogeneic) or CAR‑T cell therapy.
Have active alcohol or drug abuse.
Have a known allergic reaction to any part of the study drug.

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Verified sites

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University Hospital Cologne
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Cologne, Germany

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Investigated drugs

TRP-001 is an experimental medicine being tested for people with very high‑risk prostate cancer. It is given as an intravenous (IV) injection of a liquid solution. The drug contains a special type of radioactive material that is designed to seek out and bind to cancer cells in the prostate. By delivering radiation directly to the tumor, it aims to shrink or control the cancer before the patient undergoes surgery to remove the prostate and nearby lymph nodes. In this trial, the medication is used alone (monotherapy) as a neoadjuvant treatment, meaning it is given before the main surgical procedure to try to improve the chances of a successful operation and reduce the risk of the cancer returning.

What is already known about the treatment

TERBIUM (161TB) ZADAVOTIDE GURAXETAN - This drug is given as a sterile liquid that is injected into a vein, delivering a measured amount of radioactive material (11.1 GBq). It is still experimental and is being tested in a Phase 1 study, so it is not yet approved for regular medical use. The medicine is intended to treat very high‑risk prostate cancer before surgery by seeking out cancer cells and releasing radiation that damages their DNA. It belongs to the class of targeted radiopharmaceuticals, which combine a molecule that finds cancer cells with a radioactive element that kills them.

Investigated diseases

Prostate cancer - Prostate cancer is a malignant growth that originates in the gland of the prostate. It often begins as a small tumor confined to the prostate tissue. As the disease advances, it can extend beyond the capsule into nearby structures such as the seminal vesicles. Cancer cells may then travel to regional lymph nodes. In later stages, the disease can spread to distant sites, most commonly the bones, and other organs.