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


N/A
N/A
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome 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

Outcome Time Frame:

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

Safety Issue:

No

Authority:

Switzerland: Federal Office of Public Health

Study ID:

178/08

NCT ID:

NCT00963755

Start Date:

August 2009

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Imaging
  • Positron emission tomography
  • F-18-FCH
  • Magnetic resonance imaging
  • Magnetic resonance spectroscopy
  • Prostatic Neoplasms

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