New scan could spot hidden prostate cancer
NCT ID NCT07600554
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests a new radioactive imaging agent called 68Ga-OncoACP3 in 20 men with prostate cancer. The goal is to see if it is safe and can help detect cancer that has spread or come back. Participants receive one injection and then undergo PET scans to measure radiation doses and check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 68Ga-OncoACP3 (a radioactive imaging agent)
- What this could lead to
- If successful, this could provide a new way to detect prostate cancer spread or recurrence using PET scans, potentially guiding treatment decisions.
- What could go wrong
- This is a very early phase 1 study with only 20 participants, focused on safety and dosing, not on effectiveness. The imaging agent may not work as hoped or could have unexpected side effects.
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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2027
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 years and older
- 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. Prostate cancer patients with: * suspected metastasis who are candidates for initial definitive therapy * suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level \> 0.2 ng/mL) * metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands. (Note: patients with a negative PSMA-PET/CT or discordant PSMA-PET and FDG-PET findings are eligible for this study, providing that they have a histologically confirmed diagnosis of prostate cancer) 2. Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration. 3. Age ≥ 18 4. ECOG ≤ 1 5. Patient must not have any concomitant infections or active concomitant disease. 6. All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 6.0) Grade ≤ 1. 7. Life expectancy of more than 12 weeks. 8. Ability to undergo imaging study procedures. 9. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 10. Willingness and ability to comply with the scheduled visits, plan, laboratory tests and other study procedures. Exclusion Criteria: 1. Chronically impaired renal function as expressed by creatinine clearance \< 60 mL/min or serum creatinine \> 1.5 x ULN. Note: it is sufficient to evaluate either creatinine clearance or serum creatinine 2. Presence of active hepatitis. 3. Presence of significant cardiac disorders (congestive heart failure, NYHA class III-IV, myocardial infarction within one year prior to study entry, uncontrolled hypertension, or arrhythmia). 4. Any concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol. 5. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of the study drug. Minimally invasive procedures such as biopsies are not considered as exclusion criteria. 6. Serious, non-healing wound, ulcer, or bone fracture. 7. Allergy to study medication or excipients in study medication. 8. Any anti-cancer therapy (e.g., cytotoxic chemotherapy, immunotherapy, radiation, surgery, etc.) within 3 weeks before \[68Ga\]Ga-OncoACP3-PET/CT scan. 9. Subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from one month before \[68Ga\]Ga-OncoACP3 injection to end of study participation.
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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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. 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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
RECRUITINGBergamo, Bergamo, 24127, Italy
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Ospedale San Raffaele S.r.l.
RECRUITINGMilan, Milano, 20132, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains