An observational study in Prostatic Neoplasms, Genital Neoplasms, Male and Prostatic Diseases, sponsored by Oslo University Hospital. Active, not recruiting at 1 site in Norway. Open to male participants. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Oslo University Hospital · Observational
The purpose of the study is to combine and correlate data from morphological and functional MRI, molecular signatures of tumor hypoxia, the presence of micrometastases and tumor hypoxia with the goal being predicting of prostate cancer aggressiveness.
A prospective study including 180 consecutive patients with PCa referred to Oslo University Hospital, Radiumhospitalet, for surgical treatment. In vivo functional MRI examination will be performed within a few days prior to robot-assisted radical prostatectomy (RALP). For a subgroup of patients FACBC PET will also be acquired prior to prostatectomy. A subgroup of intermediate and high-risk patients (D'Amico risk classification) will prior to surgery receive an intravenous infusion of the hypoxia-marker pimonidazole (Hypoxyprobe™-1)*. During surgery, bone marrow aspiration and blood collection will be performed for assessment of disseminated and circulating tumor cells. High-risk patients will undergo intraoperative lymph node dissection. Tumor tissue for molecular analyses will be sampled from prostate specimen prior to fixation. Prostate specimen and regional lymph nodes will be histopathologically examined for T- and N-classification, Gleason grade, presence of micrometastasis and areas of hypoxia. Histological and molecular findings will be correlated to MRI and PET findings and clinical data. Patients will be longitudinally followed to assess long-time clinical outcome (recurrence, metastatic disease, death).
*From 2013 oral administration is used.
Prostate cancer patients referred for surgical treatment.
Exclusion Criteria:
Death
Time frame: 2030
This study is active, not recruiting, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital