Impact of F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
Sponsor study identifier
observational
60
1 country
1
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2017
Actual (reported)Study Completion
January 2018
Actual (reported)The purpose of this study is to demonstrate that realization of guided biopsies by multimodal imaging with 18F-fluorocholine PET / CT and MR Imaging/spectroscopy would allow to increase the rate of detection prostate cancer compared with the current approach and give an information about location and tumoral volume before surgery.:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
August 20, 2009
Actual (reported)August 21, 2009
Actual (reported)December 2017
Actual (reported)January 2018
Actual (reported)Sensitivity and specificity of FCH PET/CT, MR imaging, 3-D MR spectroscopy, and fusion PET/MR imaging for the intraprostatic localization of cancer in patients with radical prostatectomy as compared to histology as the gold standard
After prostatectomy (week 7-9 if Gleason score ≥ 8, week 7-15 if Gleason <8)
For prostate cancer patients with relapse: To determine the impact of FCH-PET imaging for localizing relapse patients in patients with biochemical failure as compared to the standard clinical workup
After PET/CT, week 1-2
To determine if imaging allows for a reliable estimation of tumor volume, as these limits imply a significantly different prognosis in elderly patients (insignificant disease = volume <0.5 cm3 vs. significant disease ≥0.5 cm3)
After prostatectomy (week 7-9 if Gleason score ≥ 8, week 7-15 if Gleason <8)
To determine the utility of dynamic PET imaging using 10 × 1 min acquisitions (0-9 min) as compared to a 5 min static acquisition starting 3 min and a delayed static whole-body acquisition (1 hour after radiotracer injection)
During PET/CT, week 1-2
To determine the impact of parametric PET/CT imaging based on dynamic PET acquisi¬tions with kinetic modeling
During PET/CT, week 1-2
Impact of image-guided biopsies in obtaining adequate tissue samples for histological examination as compared to TRUS-guided extended systematic 12-core biopsies
After TRUS biopsies (week 3)
For prostate cancer patients with relapse: To investigate the potential link between the overall accuracy of FCH and the serum androgen profile (total and free testosterone level) at the day of PET acquisition
After PET/CT, week 1-2
Patients referred with a suspicion of prostate cancer based on elevated PSA and rectal examination in whom a prostate biopsy is planned and radical prostatectomy is envisioned in the event of a positive biopsy finding
Patients previously treated for prostate cancer and being investigated for biochemical relapse, (mostly in the Urology and Radiation Therapy Department, but not exclusively), for whom surgical or radiation therapy is envisioned in the event of a positive FCH-PET finding
Primary prostate cancer: Patients referred with a suspicion of prostate cancer based on elevated PSA and rectal examination in whom a prostate biopsy is planned and radical prostatectomy is envisioned in the event of a positive biopsy finding Prostate cancer relapse: Patients previously treated for prostate cancer and being investigated for biochemical relapse for whom surgical or radiation therapy is envisioned in the event of a positive FCH-PET finding
Centre Hospitalier Universitaire Vaudois
Lausanne, CH, 1011, Switzerland
Surgical specimen for total prostatectomy
John O Prior, PhD MD
University of Lausanne Hospitals
60 participants (actual enrollment reported by the registry).
First Submitted
August 20, 2009
First Posted
August 21, 2009
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance
Contact the study team to confirm eligibility.
Primary Completion
December 2017
Actual (reported)Study Completion
January 2018
Actual (reported)Last Updated
July 26, 2021
Record last verified: 2021-07
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