Prostate CancerPhase 1OncoACP-3NCT06840535
A Study to Evaluate the Safety and Dosimetry of 68Ga-OncoACP3 in Patients With Prostate Cancer
A Phase 1 study testing [68Ga]Ga-OncoACP3 in people with Prostate Cancer and Prostate Cancer Metastatic Disease, run by Philogen S.p.A. at 3 sites in Italy.
Trial summary
The aim of this study is to assess the safety and dosimetry of [68Ga]Ga-OncoACP3 in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic Disease, PSA Level Greater Than 0.2
- What is being tested?
- [68Ga]Ga-OncoACP3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesItaly
- Study dates
- 8 Apr 2025to 3 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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 confirmed diagnosis of prostate cancer.
- Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
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- Age ≥ 18
- ECOG ≤ 1
- Patient must not have any concomitant infections or active concomitant disease.
- 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. 5.0) Grade ≤ 1.
- Life expectancy of more than 12 weeks.
- Ability to undergo imaging study procedures.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with the scheduled visits, plan, laboratory tests and other study procedures.
Who cannot join
- Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 x ULN.
- Presence of active hepatitis.
- 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).
- 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.
- 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.
- Serious, non-healing wound, ulcer, or bone fracture.
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- Allergy to study medication or excipients in study medication.
- Any anti-cancer therapy (e.g., cytotoxic chemotherapy, immunotherapy, radiation, surgery, etc.) within 3 weeks before [68Ga]Ga-OncoACP3-PET/CT scan.
- 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.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
ASST Papa Giovanni XXIII
Bergamo, BG, 24127
IRCCS Ospedale San Raffaele
Milan, Milano, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milano, 20133
About this study
Official title: A Phase I Study to Evaluate the Safety and Dosimetry of 68Ga-OncoACP3 in Patients With Prostate Cancer
The aim of this study is to assess the safety and dosimetry of [68Ga]Ga-OncoACP3 in patients with prostate cancer.
Read the detailed description
The Acid Phosphatase 3 (ACP3) is expressed in primary and metastatic prostate cancer lesions. OncoACP3 is a new ligand for ACP3.
This is a phase I, multicenter clinical trial to evaluate the safety, dosimetry and biodistribution of [68Ga]Ga-OncoACP3 as a PET radiotracer for the diagnostic imaging of prostate cancer. In this trial, 68Ga-OncoACP3 is offered to prostate cancer patients who already received standard of care imaging and might therefore complement available modalities.
Eligible patients for this trial are prostate cancer patients, aged 18 years or more 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
All patients will undergo PET/CT imaging with [68Ga]Ga-OncoACP3.
Patients are divided into two cohorts:
- Cohort A: 5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.
- Cohort B: all patients who meet the eligibility criteria (up to 15 patients)
Both cohorts are recruited in parallel, and patients are assigned to the respective cohort based on their disease extent. Whenever possible, patients are enrolled in cohort A, unless they are unsuitable for cohort A, or the required number of patients has already been enrolled in cohort A.
All patients will receive a single intravenous bolus administration of [68Ga]Ga-OncoACP3 and biodistribution, PK, and dosimetry of [68Ga]Ga-OncoACP3 will be assessed based on a series of PET/CT scans, blood and urine sampling.
Full dosimetry evaluations will be performed for all patients in cohort A. Dosimetry in the other patients may be performed to the extent that it is possible based on their disease burden (i.e., only organs not affected by malignant lesions can be evaluated), as appropriate.
All patients will be assessed for safety. In addition, relative uptake to appropriate reference tissue of [68Ga]Ga-OncoACP3 as well as semiquantitative parameters such as SUVmax/SUVmean/SUVsd, are determined. The correlation of [68Ga]Ga-OncoACP3 uptake with immunopathology staining for ACP3 will be evaluated in patients undergoing surgery or tumor biopsy collection. For patients who undergo PSMA-PET/CT within 4 weeks before or after the [68Ga]Ga-OncoACP3-PET/CT scan, the lesion detection rate will be compared Full dosimetry evaluations will be performed for all patients in cohort A. Additional dosimetry in the other patients may be performed to the extent that it is possible based on their disease burden (i.e., only organs not affected by malignant lesions can be evaluated).
- Being tested
- [68Ga]Ga-OncoACP3
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-OncoACP3Drug
Single intravenous bolus injection.
| Study group | Role | What they receive |
|---|---|---|
| Coort A | Experimental | 5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs. |
| Coort B | Experimental | All patients who meet the eligibility criteria (up to 15 patients) Receives: Drug: [68Ga]Ga-OncoACP3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A: Dosimetry - Effective dose equivalent (mSv)
Whole-body effective dose (mSv) following administration of a single dose of [68Ga]Ga-OncoACP3.
Measured: Assessed on day 1
Cohort A: Dosimetry - Effective dose absorbed doses (mGy)
Absorbed doses (mGy) of normal organs following administration of a single dose of [68Ga]Ga-OncoACP3.
Measured: Assessed on day 1
All patients: Safety (AEs and SAEs)
Safety of administration of [68Ga]Ga-OncoACP3, assessed based on Common Toxicity Criteria (CTCAE version 5.0)
Measured: Throughout study, until a maximum of 7 days after the administration of the study drug.
Secondary outcomes (5)
Pharmacokinetics (PK) - Blood
Pharmacokinetics (PK) of [68Ga]Ga-OncoACP3 based on measurement on blood of residual radioactivity over time [kBq/mL]
Measured: Assessed on day 1
Excretion - Urine
Excretion of [68Ga]Ga-OncoACP3 based on measurement of residual radioactivity in the urine over time [kBq]
Measured: Assessed on day 1
Biodistribution profile: SUVmax
Uptake of [68Ga]Ga-OncoACP3 in tumor lesions and healthy organs in terms of SUVmax
Measured: Assessed on day 1
Biodistribution profile: SUVmean
Uptake of [68Ga]Ga-OncoACP3 in tumor lesions and healthy organs in terms of SUVmean
Measured: Assessed on day 1
Biodistribution profile: SUVsd
Uptake of [68Ga]Ga-OncoACP3 in tumor lesions and healthy organs in terms of SUVsd
Measured: Assessed on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start8 Apr 2025
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients are divided into two cohorts: * Cohort A: 5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs. * Cohort B: all patients who meet the eligibility criteria (up to 15 patients)
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840535
- Sponsor's protocol ID
- PH-ACP3GA-01/24
- Other IDs
- 2024-515608-38-00
- Acronym
- OncoACP-3
- Status last verified
- Jan 2026
- First submitted
- 17 Feb 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Dosimetry of 68Ga-OncoACP3 in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT06840535
- Acronym / sponsor ID
- OncoACP-3 / PH-ACP3GA-01/24
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the safety and dosimetry of [68Ga]Ga-OncoACP3 in patients with prostate cancer.
Detailed description
The Acid Phosphatase 3 (ACP3) is expressed in primary and metastatic prostate cancer lesions. OncoACP3 is a new ligand for ACP3.
This is a phase I, multicenter clinical trial to evaluate the safety, dosimetry and biodistribution of [68Ga]Ga-OncoACP3 as a PET radiotracer for the diagnostic imaging of prostate cancer. In this trial, 68Ga-OncoACP3 is offered to prostate cancer patients who already received standard of care imaging and might therefore complement available modalities.
Eligible patients for this trial are prostate cancer patients, aged 18 years or more 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
All patients will undergo PET/CT imaging with [68Ga]Ga-OncoACP3.
Patients are divided into two cohorts:
- Cohort A: 5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.
- Cohort B: all patients who meet the eligibility criteria (up to 15 patients)
Both cohorts are recruited in parallel, and patients are assigned to the respective cohort based on their disease extent. Whenever possible, patients are enrolled in cohort A, unless they are unsuitable for cohort A, or the required number of patients has already been enrolled in cohort A.
All patients will receive a single intravenous bolus administration of [68Ga]Ga-OncoACP3 and biodistribution, PK, and dosimetry of [68Ga]Ga-OncoACP3 will be assessed based on a series of PET/CT scans, blood and urine sampling.
Full dosimetry evaluations will be performed for all patients in cohort A. Dosimetry in the other patients may be performed to the extent that it is possible based on their disease burden (i.e., only organs not affected by malignant lesions can be evaluated), as appropriate.
All patients will be assessed for safety. In addition, relative uptake to appropriate reference tissue of [68Ga]Ga-OncoACP3 as well as semiquantitative parameters such as SUVmax/SUVmean/SUVsd, are determined. The correlation of [68Ga]Ga-OncoACP3 uptake with immunopathology staining for ACP3 will be evaluated in patients undergoing surgery or tumor biopsy collection. For patients who undergo PSMA-PET/CT within 4 weeks before or after the [68Ga]Ga-OncoACP3-PET/CT scan, the lesion detection rate will be compared Full dosimetry evaluations will be performed for all patients in cohort A. Additional dosimetry in the other patients may be performed to the extent that it is possible based on their disease burden (i.e., only organs not affected by malignant lesions can be evaluated).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are divided into two cohorts: * Cohort A: 5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs. * Cohort B: all patients who meet the eligibility criteria (up to 15 patients)
| Arm | Type | Receives |
|---|---|---|
| Coort A | Experimental | –5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs. |
| Coort B | Experimental | Drug: [68Ga]Ga-OncoACP3All patients who meet the eligibility criteria (up to 15 patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Prostate cancer patients with:
- 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 confirmed diagnosis of prostate cancer.
- Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
- Age ≥ 18
- ECOG ≤ 1
Key exclusion criteria (9 listed)
- Chronically impaired renal function as expressed by creatinine clearance < 60 mL/min or serum creatinine > 1.5 x ULN.
- Presence of active hepatitis.
- 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).
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-OncoACP3Single intravenous bolus injection. | Drug | Coort B |
Primary outcome
Cohort A: Dosimetry - Effective dose equivalent (mSv)
Time frame: Assessed on day 1
Whole-body effective dose (mSv) following administration of a single dose of [68Ga]Ga-OncoACP3.
Cohort A: Dosimetry - Effective dose absorbed doses (mGy)
Time frame: Assessed on day 1
Absorbed doses (mGy) of normal organs following administration of a single dose of [68Ga]Ga-OncoACP3.
All patients: Safety (AEs and SAEs)
Time frame: Throughout study, until a maximum of 7 days after the administration of the study drug.
Safety of administration of [68Ga]Ga-OncoACP3, assessed based on Common Toxicity Criteria (CTCAE version 5.0)
5 secondary outcomes
Pharmacokinetics (PK) - Blood
Time frame: Assessed on day 1
Excretion - Urine
Time frame: Assessed on day 1
Biodistribution profile: SUVmax
Time frame: Assessed on day 1
Biodistribution profile: SUVmean
Time frame: Assessed on day 1
Biodistribution profile: SUVsd
Time frame: Assessed on day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [68Ga]Ga-OncoACP3 in people with Prostate Cancer and Prostate Cancer Metastatic Disease, run by Philogen S.p.A. at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort A: Dosimetry - Effective dose equivalent (mSv) (time frame: Assessed on day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.