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

NCT00963755 | Completed

• 1 other identifier: 178/08
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.:

Conditions

Prostate Cancer

Keywords

Imaging; Positron emission tomography; F-18-FCH; Magnetic resonance imaging; Magnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (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

  After prostatectomy (week 7-9 if Gleason score ≥ 8, week 7-15 if Gleason <8)

• 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 Outcomes (5)

• 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)

• 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

• To determine the impact of parametric PET/CT imaging based on dynamic PET acquisi¬tions with kinetic modeling

  During 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

  After TRUS biopsies (week 3)

• 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

Study Arms (2)

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 Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Coexistence of another clinically-proven cancer
• Contraindications to surgery or radiation therapy treatment

Sponsors & Collaborators

• University of Lausanne Hospitals: lead
• Advanced Accelerator Applications: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, CH, 1011, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Surgical specimen for total prostatectomy

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John O Prior, PhD MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Department Head

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)