MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

Prostatic Neoplasms Clinical Trial

— FuncProst  

Official title:

MRI for Assessment of Hypoxia-Induced Prostate Cancer Aggressiveness

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01464216
• Other study ID #: REK-2010/1656
• Status: Active, not recruiting
• Start date: October 2011
• Est. completion date: December 2030

Study information

• Verified date: June 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2030
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients suitable for surgery with confirmed prostate cancer, Gleason grade = 3

• Patient has received no prior treatment for prostate cancer.

• Patient has adequate renal function: Estimated creatinine clearance = 60 ml/minute.

• Patient must sign written informed consent according to the protocol approved by the Regional Ethics Committee.

Exclusion Criteria:

• Patient with contraindication to MR or MR contrast media according to clinical practice.

• Patients who want to withdraw for any reason during the study.

• Patients previously undergone pelvic surgery or radiation therapy

Related Conditions & MeSH terms

• Aggression
• Genital Neoplasms, Male
• Hypoxia
• Neoplasms
• Prostatic Diseases
• Prostatic Neoplasms

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Radboud University Medical Center

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		2030