Clinical trial NCT00963755: F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
Official title: Impact of F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Imaging
Positron emission tomography
F-18-FCH
Magnetic resonance imaging
Magnetic resonance spectroscopy
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Advanced Accelerator Applications
First posted: 2009-08-21
Enrollment: 60
Sex: MALE
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 for whom surgical or radiation therapy is envisioned in the event of a positive FCH-PET finding

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.

Eligibility 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-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

Primary outcomes:
measure: 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
timeFrame: After prostatectomy (week 7-9 if Gleason score ≥ 8, week 7-15 if Gleason <8)
measure: 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
timeFrame: After PET/CT, week 1-2
Secondary outcomes:
measure: 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)
timeFrame: After prostatectomy (week 7-9 if Gleason score ≥ 8, week 7-15 if Gleason <8)
measure: 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)
timeFrame: During PET/CT, week 1-2
measure: To determine the impact of parametric PET/CT imaging based on dynamic PET acquisi¬tions with kinetic modeling
timeFrame: During PET/CT, week 1-2
measure: Impact of image-guided biopsies in obtaining adequate tissue samples for histological examination as compared to TRUS-guided extended systematic 12-core biopsies
timeFrame: After TRUS biopsies (week 3)
measure: 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
timeFrame: After PET/CT, week 1-2
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: CH
Study officials:
affiliation: University of Lausanne Hospitals
name: John O Prior, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: