A prospective, Phase 3, multi-center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA-7.3 (18F) PET ligand in men with newly diagnosed prostate cancer

Blue Earth Diagnostics Ireland Ltd.0 个研究点目标入组 375 人开始时间: 2020年3月12日最近更新: 2022年4月4日

适应症

试验速览

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•1. Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible.
•2. Patient is male and aged >18 years old.
•3. Histologically confirmed adenocarcinoma of the prostate.
•4. Candidate for RP with PLND and scheduled to undergo the surgical procedure.
•5. Patient with either:
•a) Unfavorable intermediate risk (disease, defined as:
•- Any Gleason Grade Grouping [GGG] 3, or
•- GGG 2 with =50% of biopsy cores positive for PCa and/or >1 Intermediate Risk Factor [T2b; T2c; PSA 10-20] or
•b) High risk or very high risk disease (per NCCN Guidelines Version 1.2020; PROS 2).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 225
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•1. Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements.
•2. Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
•3. Patients currently receiving, or with a prior history of, androgen deprivation therapy (ADT; defined as surgical orchidectomy; luteinizing hormone-releasing hormone [LHRH] agonist alone [continuous or intermittent]; LHRH antagonist alone [continuous or intermittent]; administration or use of a first generation or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
•4. Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to administration of rhPSMA-7.3 (18F).
•5. Patients with known hypersensitivity to the active substance or to any of the excipients of the IP.

发起方

Blue Earth Diagnostics Ireland Ltd.