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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Lausanne Hospitals.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Advanced Accelerator Applications
Centre d'Imagerie Biomédicale (CIBM), Lausanne, Switzerland
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00963755
First received: August 20, 2009
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

The purpose of this study is:

  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.

Condition
Prostate Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

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 [ Time Frame: After prostatectomy (week 7-9 if Gleason score ≥ 8, week 7-15 if Gleason <8) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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) [ Time Frame: After prostatectomy (week 7-9 if Gleason score ≥ 8, week 7-15 if Gleason <8) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Surgical specimen for total prostatectomy


Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963755

Contacts
Contact: John O Prior, PhD MD +41 21 314 4348 john.prior@chuv.ch
Contact: Jean-Yves Meuwly, MD +41 21 314 4395 jean-yves.meuwly@chuv.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, CH, Switzerland, 1011
Principal Investigator: John O Prior, PhD MD         
Sponsors and Collaborators
University of Lausanne Hospitals
Advanced Accelerator Applications
Centre d'Imagerie Biomédicale (CIBM), Lausanne, Switzerland
  More Information

No publications provided

Responsible Party: John O. Prior, Professor and Department Head, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00963755     History of Changes
Other Study ID Numbers: 178/08
Study First Received: August 20, 2009
Last Updated: April 16, 2012
Health Authority: Switzerland: Federal Office of Public Health
Switzerland: Swissmedic

Keywords provided by University of Lausanne Hospitals:
Imaging
Positron emission tomography
F-18-FCH
Magnetic resonance imaging
Magnetic resonance spectroscopy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014