AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

An Open-Label, Phase 1 Dose-finding Study to Define the Maximum Tolerated Dose and Schedule of TRP-001 as Neoadjuvant Therapy in Treatment-naïve Very High-Risk Prostate Cancer Patients Eligible for Radical Prostatectomy with Extended Pelvic Lymph Node Dissection

This Phase 1 clinical trial is looking at a new treatment called TRP-001 for men with newly diagnosed, high-risk prostate cancer. Participants will receive this treatment before having surgery to remove their prostate gland and nearby lymph nodes. Because this is the first time TRP-001 is being tested in humans, the main goal is to find the safest and most effective dose. Researchers want to monitor any side effects and see how the body handles the medicine. They will also check whether the drug shrinks the tumour before surgery, how easily the surgeon can carry out the operation afterwards, and how the cancer responds under a microscope. Taking part helps researchers understand if giving this targeted therapy before surgery could improve future care for men facing aggressive prostate cancer.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Torpedo Pharmaceuticals AG

Enrolment target

Start

04 Sep 2026

Prostate cancer

What is this study about?

Prostate cancer is one of the most common cancers in men. When the cancer is classed as 'very high-risk', it means it is fast-growing and has a greater chance of spreading or returning after treatment. Standard care often involves an operation called a radical prostatectomy, which removes the entire prostate gland along with nearby lymph nodes to clear the disease.

This clinical trial is testing an experimental medicine called TRP-001. Doctors give this treatment before surgery—an approach known as 'neoadjuvant' therapy. The hope is that giving a targeted medicine first might help shrink the tumour, tackle stray cancer cells, and make the upcoming operation more effective.

Because this is a Phase 1 study, it is the first time TRP-001 is being given to humans. The primary focus is safety. Doctors will start with carefully measured doses and closely monitor patients to see how the body absorbs the medicine and to identify the highest dose that can be given safely without causing difficult side effects.

Researchers will also study the tissue removed during your planned operation. This helps them see directly how much cancer was destroyed by TRP-001. By joining, participants contribute vital knowledge that could shape better treatments for aggressive prostate cancer in the future.

Key takeaways

This is a Phase 1 study testing a new medicine called TRP-001 for the first time in humans.
It is aimed at men with newly diagnosed, high-risk prostate cancer who are already planning surgery.
The treatment is given before an operation to remove the prostate and pelvic lymph nodes.
The primary aim is to test the drug's safety, find the best dose, and monitor any side effects.
Participation is entirely voluntary and designed to fit alongside your planned surgical care.

Who may be eligible?

This trial is designed for adult men aged 18 and over who have recently been diagnosed with very high-risk prostate cancer. To take part, you must be 'treatment-naïve', which means you have not yet received any hormone therapy, chemotherapy, or other medical treatments for your prostate cancer.

You must also be planned and medically fit to undergo surgery to remove your prostate gland and nearby pelvic lymph nodes. Your hospital care team will confirm whether your tumour meets the specific criteria for 'very high-risk' disease.

Men who have already started treatment for prostate cancer, or who have other significant medical conditions that make experimental therapy or major surgery unsafe, will not be able to join. The study team will run routine checks to ensure taking part is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a man aged 18 or older.
I have recently been diagnosed with very high-risk prostate cancer.
I have not yet started any cancer treatments (such as hormone therapy or chemotherapy).
I am scheduled and fit enough to have surgery to remove my prostate and lymph nodes.
I am willing to attend extra hospital visits for monitoring, scans, and blood tests.

Answer every question to see your result.

What does participation involve?

Taking part begins with screening tests, such as blood samples and imaging scans, to make sure the study is suitable for you. If you join, you will receive TRP-001 as planned before your surgery date. During this time, you will attend hospital visits so doctors can monitor your health, perform blood tests, and take specialised scans to see where the medicine travels in your body. After completing the treatment, you will have your planned prostate surgery. Following your operation, the surgical team will check how well you recover, and the researchers will examine the removed tissue. Total participation lasts several months, covering your treatment, surgery, and follow-up recovery visits.

Potential risks and benefits

Because TRP-001 is being given to people for the first time, there may be unexpected side effects, and there is no guarantee that the medicine will shrink your cancer or improve your health. There is also a small chance it could cause side effects that affect your surgery. However, the treatment may help weaken the tumour before your operation, and your participation will provide crucial information to help future patients. Your health is closely watched at all times. Taking part is completely voluntary, and you have the right to withdraw from the trial at any point without your standard NHS care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is the main goal of a Phase 1 trial?

A Phase 1 trial is the first step in testing a new medicine in people. Its main goal is to find a safe dose and learn what side effects the drug might cause.

What does 'neoadjuvant therapy' mean?

'Neoadjuvant' simply means giving a treatment, such as a medicine, before the main treatment, which in this case is your prostate operation.

Will taking this medicine delay my prostate surgery?

The trial is planned carefully around your surgical timeline. Your doctor will make sure your surgery takes place safely and promptly after the study treatment.

Can I leave the study if I change my mind?

Yes. You can leave the study at any time, for any reason. Doing so will not affect the standard of care you receive from your doctors.

Does taking part cost anything?

No. The trial medicine and all extra tests are free of charge. In many cases, help with travel expenses to and from the hospital is also available.