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

NCT ID: NCT00963755

Last Updated: 2021-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2018-01-31

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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.

• 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

• 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

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

• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Advanced Accelerator Applications

INDUSTRY

Sponsor Role: collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

John O. Prior

Professor and Department Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John O Prior, PhD MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, CH, Switzerland

Countries

Switzerland

Other Identifiers

178/08

Identifier Type: -

Identifier Source: org_study_id