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Completed

NCT Number: NCT00963755

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

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.:

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Key information

Age range

Up to 80 year

Sex eligibility

Male

Study type

Observational

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH, 1011, Switzerland

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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)

  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

  3. 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

  4. 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)

  5. 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

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Collaborators

  • Advanced Accelerator Applications

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2017
Study completion
2018
First posted
Aug 21, 2009
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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