Clinical trial • Phase II|Phase IV • Oncology

18F-PSMA-1007 for Clinically significant prostate cancer

Phase II|Phase IV trial of 18F-PSMA-1007 for Clinically significant prostate cancer. None/Not specified-controlled. 167 participants.

Overview

None/Not specified-controlled Phase II|Phase IV trial across 1 site in Italy.

Recruits 167 No vulnerable populations selected; participants must be 18 years or older and able to provide informed consent..

Vulnerable Population: No vulnerable populations selected; participants must be 18 years or older and able to provide informed consent.

{"criterion_text":"- Patients 18 years of age or older, identified as suspects for clinically significant prostate cancer\n- Ability to undergo all protocol scrutiny\n- Ability to provide informed consent"}

{"criterion_text":"- Previous diagnosis of prostate cancer\n- Contraindications to perform the MRI examination (e.g. claustrophobia, pacemaker, estimated GFR less than or equal to 50mls/min)\n- Contraindications to perform the prostate biopsy"}

{"endpoint_text":"- Diagnostic accuracy measured by sensitivity, specificity, and positive and negative predictive values","definition_or_measurement_approach":"Diagnostic accuracy measured by sensitivity, specificity, and positive and negative predictive values"}

Planned Sample Size: 167
Recruitment Window Months: 26
Consent Approach: Adults (≥18) must provide informed consent; subject information and informed consent form documents for adults are listed (L1_ICF_adults_Redacted, L1_SIS_adults, L2_ICF Privacy statement_tc, L2 _Patient_card_CL_Redatto). No assent for minors (participants must be 18+). Languages of consent documents not specified.

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