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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963755
• Other study ID #: 178/08
• Status: Completed
• Start date: August 2009
• Est. completion date: January 2018

Study information

• Verified date: July 2021
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 80 Years

Eligibility

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-a 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	CH

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	Advanced Accelerator Applications

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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
Secondary	To determine the impact of parametric PET/CT imaging based on dynamic PET acquisi¬tions with kinetic modeling		During PET/CT, week 1-2
Secondary	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)
Secondary	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