NCT07600554 A Phase I Study to Evaluate the Safety and Dosimetry of Imaging With 68Ga-OncoACP3 in Prostate Cancer
| NCT ID | NCT07600554 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Philogen S.p.A. |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-27 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-05-27 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to assess the safety and dosimetry of imaging with \[68Ga\]Ga-OncoACP3 in patients with prostate cancer.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07600554 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07600554 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07600554 currently recruiting?
Yes, NCT07600554 is actively recruiting participants. Contact the research team at regulatory@philogen.com for enrollment information.
Where is the NCT07600554 trial being conducted?
This trial is being conducted at Bergamo, Italy, Milan, Italy.
Who is sponsoring the NCT07600554 clinical trial?
NCT07600554 is sponsored by Philogen S.p.A.. The trial plans to enroll 20 participants.
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