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 suspected prostate cancer recurrence based on elevated PSA following prior therapy - 302 SPOTLIGHT

Blue Earth Diagnostics0 个研究点目标入组 15 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. Patient with a history of localized adenocarcinoma of the prostate with
•prior curative intent treatment, experiencing BCR of PCa potentially eligible
•for salvage therapy with curative intent, following prior treatment with one or
•more of the following: a) RP, b) RP plus adjuvant RT, c) RP plus adjuvant
•androgen deprivation therapy (ADT), d) external beam radiation therapy or e)
•focal gland therapies (e.g. brachytherapy, high-intensity focused ultrasound
•- At least 6 weeks must have elapsed after RP.
•- If previously taking ADT, it should have been discontinued at least 16 weeks
•prior to screening.
•- In the case of focal gland therapies (e.g. HIFU) and RT, the treatment will
•have occurred at least 1 year prior to screening.
•4. An elevated PSA, clinically suspicious for biochemically recurrent disease:
•- Following RP: initial PSA >=0.2 ng/mL followed by a subsequent confirmatory
•PSA value >=0.2 ng/mL.
•- Following RT (e.g. radical radiotherapy or brachytherapy): nadir +2 ng/mL.
•- Following focal gland therapies (e.g. HIFU): nadir +2 ng/mL
•5. Patient willing to undergo biopsy for histological confirmation of
•rhPSMA-7.3 (18F) PET findings, where safe and feasible.

•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 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).

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