Clinical trial • Phase III • Oncology

18F-PSMA-1007 for Prostate cancer

Phase III trial of 18F-PSMA-1007 for Prostate cancer. 20 participants.

Overview

Phase III trial in Sweden.

Recruits 20 No vulnerable populations selected. Participants are adults (>18 years) and must provide written consent to participate in the trial..

Vulnerable Population: No vulnerable populations selected. Participants are adults (>18 years) and must provide written consent to participate in the trial.

{"criterion_text":"-Histologically confirmed high-risk prostate cancer planned to be treated with radical prostatectomy"}
{"criterion_text":"-PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer"}
{"criterion_text":"-≥4 weeks since last biopsy of the prostate"}
{"criterion_text":"-One or more of the following criteria: a) cT3, or high suspicion of extra prostatic growth on mpMRI b) Gleason score ≥8 c) PSA 20-49 ng/ml"}
{"criterion_text":"->18 years"}
{"criterion_text":"-Given a written consent to participate in the trial"}

{"criterion_text":"-Non-MR-safe implants or another contraindication to MRI or PET"}
{"criterion_text":"-Tinnitus or severe hearing loss"}
{"criterion_text":"-Claustrophobia"}
{"criterion_text":"-Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain"}
{"criterion_text":"-WHO PS >1"}
{"criterion_text":"-Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration such or anti-androgens)"}
{"criterion_text":"-TUR-P within 6 months"}
{"criterion_text":"-Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis."}
{"criterion_text":"-Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumor."}
{"criterion_text":"-Creatinine clearance < 30ml/min"}

{"endpoint_text":"-The primary endpoint is spatially defined aggressive PC lesions, or subparts of lesions, identified and defined using PSMA-PET and/or mpMRI compared to histopathology","definition_or_measurement_approach":"Identification and delineation of most clinically relevant intra-prostatic lesions or sub-regions using PSMA-PET and/or mpMRI with histopathology as the reference standard."}

{"endpoint_text":"-The secondary endpoints are biochemical disease-free survival, time to relapse, overall survivor and surgical margins.","definition_or_measurement_approach":"Clinical outcomes including biochemical disease-free survival, time to relapse, overall survival and assessment of surgical margins (measurement methods not otherwise specified)."}
{"endpoint_text":"-The secondary endpoint is to the assess the radiological extracapsular extension and seminal vesicle involvement in comparison to histopathological evaluation.","definition_or_measurement_approach":"Radiological assessment of extracapsular extension and seminal vesicle involvement compared to histopathology as reference."}
{"endpoint_text":"-The exploratory endpoint of the study is also the spatially defined most aggressive PC lesions, or subparts of lesions.","definition_or_measurement_approach":"Exploratory spatial definition of most aggressive prostate cancer lesions or subparts; compared to histopathology."}
{"endpoint_text":"-The safety endpoint is subject-reported adverse events up to one week after treatment.","definition_or_measurement_approach":"Collection of subject-reported adverse events within one week after treatment."}

Planned Sample Size: 20
Recruitment Window Months: 94
Consent Approach: Written informed consent is required from participants. Participants must be adults (>18 years). No information provided on assent, age-specific documents, or languages available.

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