WISER-P: Real-world testing of software for measuring bone disease on whole-body MRI in patients with prostate cancer

Institute of Cancer Research0 个研究点目标入组 126 人开始时间: 2023年10月12日最近更新: 2023年10月23日

适应症

试验速览

暂无简介。

•1. Age > = 18 years.
•2. Metastatic castration-resistant prostate cancer with bone-predominant disease confirmed on bone scan, CT, or limited (pelvic) MRI performed within 8 weeks prior to trial entry (bone-predominant disease confirmed on the CT component of PET-CT is permissible).
•3. Systemic therapy (any line) clinically indicated and planned for the treatment of disease progression, as defined and confirmed locally with potential definitions including but not limited to:
•3.1. Progression on a bone scan: > = 2 new documented bone lesions over the previous 6 months
•3.2. AND/OR increasing PSA level: 2 consecutive increases in PSA level documented over a previous reference value obtained at least one week apart. If the third PSA value is less than the second, an additional fourth test to confirm the rising PSA is required.
•4. Willing and able to comply with the protocol-defined imaging assessments.
•5. Fully informed about the study and provided written informed consent.

•1. Unsuitable for WBMRI (patient refusal and/or contraindicated)
•2. Patients with RECIST-measurable disease
•3. Any radiotherapy within 8 weeks prior to trial entry (chemotherapy or other anti-cancer therapy are permissible).

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