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| Name | Class |
|---|---|
| Advanced Accelerator Applications | INDUSTRY |
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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.:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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PRIMARY PROSTATE CANCER
Inclusion Criteria:
Age ≤ 80 years
Karnofsky index ≥ 80
First prostate biopsy
Presence of at least one of the following:
Informed signed consent.
Exclusion Criteria:
PROSTATE CANCER RELAPSE
Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| John O Prior, PhD MD | University of Lausanne Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Surgical specimen for total prostatectomy
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |