Clinical trial • Phase I • Oncology
68Ga-OncoACP3 for Prostate cancer|Recurrent prostate cancer|Metastatic prostate cancer
Phase I trial of 68Ga-OncoACP3 for Prostate cancer|Recurrent prostate cancer|Metastatic prostate cancer. 20 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Prostate cancer|Recurrent prostate cancer|Metastatic prostate cancer
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 22-12-2025
- First CTIS Authorization Date
- 22-04-2026
Trial design
Phase I trial across 2 sites in Italy.
- Target Sample Size
- 20
Eligibility
Recruits 20 Vulnerable population not selected; no specific consent or assent handling details provided..
- Vulnerable Population
- Vulnerable population not selected; no specific consent or assent handling details provided.
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 10
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 20
Italy
- Earliest CTIS Part Ii Submission Date
- 01-04-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 21
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Nuclear Medicine
- Contact Person Name
- Arturo Chiti
- Contact Person Email
- chiti.arturo@hsr.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- SC Nuclear Medicine
- Contact Person Name
- Paola Anna Erba
- Contact Person Email
- perba@asst-pg23.it
Sponsor
Primary sponsor
- Full Name
- Philogen S.p.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- 68Ga-OncoACP3
- Active Substance
- 68Ga-OncoACP3
- Modality
- Radiopharmaceutical
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