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 - 301 LIGHTHOUSE

Blue Earth Diagnostics0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月23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 scheduled to undergo the surgical procedure.
•5. Unfavorable intermediate risk (Gleason Grade Grouping [GGG] 2 with >=50% of
•biopsy cores positive for PCa and/or >1 Intermediate Risk Factor [T2b; T2c; PSA
•10-20] or Any GGG 3) or high risk or very high risk disease (per NCCN
•Guidelines Version 2.2019; PROS-2).

•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).

发起方