Clinical trial · Observational
F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
Impact of F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer
NCT00963755CI-TRIAL-00052898completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Primary prostate cancer
- description
- 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
- label
- Prostate cancer relapse
- description
- 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
Primary outcomes (2)
- 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
- timeFrame
- After prostatectomy (week 7-9 if Gleason score ≥ 8, week 7-15 if Gleason <8)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.