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

Sponsor

University of Lausanne Hospitals (Other)

Overall Status

Completed

CT.gov ID

NCT00963755

Collaborator

Advanced Accelerator Applications (Industry)

Enrollment

Location

101

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.:

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer

Detailed Description

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.
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 Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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, (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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

PRIMARY PROSTATE CANCER

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.