Trials Sponsors Conditions Drugs Pricing

Conditions

Prostate CancerPatients with prostate cancer 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Keywords

Prostate CancerPET/CT imagingACP3PSMA

Outcome Measures

Primary Outcomes (2)

Adverse events (AEs) and Serious Adverse Events (SAEs)
Adverse events (AEs) and Serious Adverse Events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v.6.0.
Throughout study, until a maximum of 7 days after the administration of the study drug.
Effective dose equivalent (mSv) and absorbed doses (mGy)
Effective dose equivalent (mSv) and absorbed doses (mGy) of normal organs following administration of a single dose of \[68Ga\]Ga-OncoACP3.
Assessed on day 1

Study Arms (2)

Cohort A

EXPERIMENTAL

5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.

Drug: [68Ga]Ga-OncoACP3

Cohort B

EXPERIMENTAL

All patients who meet the eligibility criteria (up to 15 patients).

Drug: [68Ga]Ga-OncoACP3

Interventions

[68Ga]Ga-OncoACP3Drug

Single intravenous bolus injection.

Cohort ACohort B

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Prostate cancer patients with:
suspected metastasis who are candidates for initial definitive therapy

Sponsors & Collaborators

Philogen S.p.A.
Industrylead

Study Sites (2)

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, Bergamo, 24127, Italy

Ospedale San Raffaele S.r.l.

Milan, Milano, 20132, Italy

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 20, 2026

Study Start

May 27, 2026

A Phase I Study to Evaluate the Safety and Dosimetry of Imaging With 68Ga-OncoACP3 in Prostate Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Cohort A

Cohort B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Cohort A

Cohort B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations