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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00963755
• Date of registration: 20/08/2009
• Primary sponsor: University of Lausanne Hospitals
• Public title: Impact of F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
• Scientific title: Impact of F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
• Date of first enrolment: August 2009
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00963755
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

Switzerland

Contacts

• Name: John O Prior, PhD MD

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: 80 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Primary Outcome(s)

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 [Time Frame: After PET/CT, week 1-2]

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 [Time Frame: After prostatectomy (week 7-9 if Gleason score = 8, week 7-15 if Gleason <8)]

Secondary Outcome(s)

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 [Time Frame: 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 [Time Frame: After TRUS biopsies (week 3)]

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) [Time Frame: After prostatectomy (week 7-9 if Gleason score = 8, week 7-15 if Gleason <8)]

To determine the impact of parametric PET/CT imaging based on dynamic PET acquisi¬tions with kinetic modeling [Time Frame: During PET/CT, week 1-2]

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) [Time Frame: During PET/CT, week 1-2]

Secondary ID(s)

178/08

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Advanced Accelerator Applications

Centre d'Imagerie Biomédicale (CIBM), Lausanne, Switzerland