Status:
COMPLETED
F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
Lead Sponsor:
University of Lausanne Hospitals
Collaborating Sponsors:
Advanced Accelerator Applications
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 80 years
Brief Summary
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 de...
Detailed Description
1. To evaluate the utility of F-18-FCH-PET/CT and MR imaging with 3-D MR spectroscopy in detecting, localizing, and estimating the volume of initial primary prostate cancer as compared to the current ...
Eligibility Criteria
Inclusion
- PRIMARY PROSTATE CANCER
- Age ≤ 80 years
- Karnofsky index ≥ 80
- First prostate biopsy
- Presence of at least one of the following:
- Total PSA 10 ng/mL
- Total PSA 2.5-10 ng/mL with free-PSA \<20% and/or PSA velocity 0.75 ng/mL/year
- Suspicious hypoechoic lesion at TRUS and/or suspicious finding at digital rec¬tal examination
- Informed signed consent.
Exclusion
- Impaired capacity to consent
- Coexistence of clinically-proven prostate cancer
- Neoadjuvant hormonal treatment (including 5-α reductase inhibitors)
- Contraindications to surgery
- Contraindications to MR Imaging (see below)
- PROSTATE CANCER RELAPSE
- Inclusion Criteria:
- Age ≤ 90 years
- Karnofsky index ≥ 80
- Previous treatment for prostate cancer
- No clinical recurrence based on standard work-up (abdominal / pelvic CT, MRI, and bone scintigraphy)
- Biochemically proven relapse of prostate cancer (PSA \> 0.2 ng/mL after prostatectomy, nadir PSA+2 ng/mL (Phoenix definition) or ≤ 3 successive rising PSA levels (ASTRO definition) after curative radiotherapy).
- Informed signed consent.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00963755
Start Date
August 1 2009
End Date
January 1 2018
Last Update
July 26 2021
Active Locations (1)
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1
Centre Hospitalier Universitaire Vaudois
Lausanne, CH, Switzerland, 1011