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Radioactive 'Smart Bomb' targets Hard-to-Treat prostate cancer

NCT ID NCT07660211

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new drug called 177Lu-PSMA-VG01 in men with a specific type of advanced prostate cancer (PSMA-positive mCRPC) that has spread and stopped responding to hormone therapy. The drug is designed to deliver radiation directly to cancer cells, aiming to shrink tumors while limiting damage to healthy tissue. The study focuses on safety, how the drug moves through the body, and whether it shows any signs of fighting the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
177Lu-PSMA-VG01 (a radioactive molecule that targets prostate cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for men with advanced prostate cancer that has spread and no longer responds to standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 10 participants, so safety and effectiveness are not yet established. The radioactive drug may cause side effects like damage to healthy organs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male participants aged 18 years (inclusive) to 80 years (exclusive) at the time of signing the informed consent. 2. Histologically or cytologically confirmed prostate cancer with no standard treatment options available, or failure/intolerance to standard therapies, or inability to access standard treatment. 3. During the screening period, imaging examinations (within 4 weeks before administration) showed the presence of ≥1 metastatic lesion. 4. ECOG Performance Status score: 0 to 2. 5. Expected survival time exceeds 6 months. 6. All clinically significant toxicities related to prior anti-tumor therapy (e.g., chemotherapy, radiotherapy, etc., excluding Luteinizing Hormone-Releasing Hormone (LHRH) analog therapy) must have resolved to ≤ Grade 1, except for toxicities deemed safe and manageable by the investigator, such as alopecia, peripheral neuropathy ≤ Grade 2, etc. (CTCAE V6.0). 7. The participant must be fully informed about the study and voluntarily provide written informed consent prior to participation. 8. The participant must be capable of understanding and complying with the requirements of the trial protocol. 9. The participant must use a condom during sexual activity throughout the study period and for 14 weeks after the last dose of study treatment to prevent pregnancy in partners and potential exposure of partners to the investigational product g via semen. Additionally, the participant should refrain from sperm donation during the specified timeframe above. Exclusion Criteria: 1. Having received anti-tumor therapies such as chemotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose of the investigational product, or planning to receive such therapies during the study period. 2. Having received systemic or local radionuclide therapy within 3 months prior to the first dose. 3. Having received other investigational product treatments not yet approved within 4 weeks prior to the first dose of the investigational product, or within five half-lives of that. 4. Having undergone major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dose of the investigational product, or requiring elective surgery during the trial period. 5. Having been diagnosed with other malignancies within the past 2 years (participants with a prior history of malignancy who have received adequate treatment and have remained disease- and treatment-free for over 3 years prior to enrollment are eligible, as are patients with adequately treated non-melanoma skin cancer or superficial bladder cancer). 6. Having symptomatic spinal cord compression or clinical/imaging findings suggestive of impending spinal cord compression. 7. Known allergy to structural analogs of this product or other excipients. 8. Having a history of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; a history of severe autoimmune diseases deemed unsuitable for enrollment by the investigator; or requiring immunosuppressive therapy for allogeneic organ transplantation. 9. Having severe infections (requiring intravenous antibiotics, antifungals, or antivirals according to clinical practice guidelines), active hepatitis A, active hepatitis B (HBV DNA ≥2000 IU/mL or 10\^4 copies/mL; prophylactic antiviral therapy other than interferon is allowed), active hepatitis C (anti-HCV positive and HCV-RNA above the lower limit of detection), or active syphilis infection. 10. Having uncontrolled third-space fluid accumulations (such as significant pleural effusion, ascites or pericardial effusion) deemed unsuitable for enrollment by the investigator. 11. Having a clear history of neurological or psychiatric disorders, including epilepsy or dementia. 12. Other reasons considered by the investigator to make the participant unsuitable for participation in this clinical study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zhong Shan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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