Oslo University Hospital
Oslo, 0310, Norway
NCT Number: NCT01464216
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.
This study is active but is not currently recruiting participants.
Male
Observational
Oslo, 0310, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2030
Oslo University Hospital
Other
Acronym: FuncProst
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06706921
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Los Angeles, California, United States
View Trial DetailsNCT05413850
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Miami, Florida, United States
View Trial DetailsNCT00853710
Genital Diseases, Genital Diseases, Male
Saint-Cloud, France
View Trial DetailsNCT05574647
Adenocarcinoma, Carcinoma
Southend-on-Sea, Essex, United Kingdom
View Trial Details