Radioactive 'Smart Bomb' targets Hard-to-Treat prostate cancer
NCT ID NCT07660211
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Zhong Shan Hospital Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Can a Cancer-Targeting drug slow advanced prostate cancer?
- Can a smart radiation drug hunt down prostate cancer cells?
- Can a new daily pill slow advanced prostate cancer?