F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00963755
• Lead Sponsor: University of Lausanne Hospitals

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 detection prostate cancer compared with the current approach and give an information about location and tumoral volume before surgery.:

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 standard work-up using TRUS-guided biopsy. All imaging findings will be correlated with "gold standard" step slice histological examination. The hypothesis is that the combination of noninvasive imaging will improve the preoperative work-up as compared to the current approach.

2. To evaluate FCH-PET for the restaging of prostate cancer after biochemical relapse in a large patient cohort. This will run in parallel to the work-up of primary prostate cancer, as the FCH radiopharmaceutical will be available during the time of study at absolutely no cost to patients or CHUV. A number of studies have demonstrated the benefits of F-18-FCH-PET/CT for these patients and this indication is currently not reimbursed by Swiss obligatory health insurance providers.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Primary Completion: 2017-12
• Study Completion: 2018-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• 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 Criteria

• 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.

Exclusion Criteria:

• Coexistence of another clinically-proven cancer
• Contraindications to surgery or radiation therapy treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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
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)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, CH, Switzerland