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| Name | Class |
|---|---|
| Hospital Universitario Reina Sofia de Cordoba | OTHER_GOV |
| Hospitales Universitarios Virgen del Rocío | OTHER |
| Institut Universitaire du Cancer de Toulouse | OTHER |
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The evidence base relating to the use of SCAP and HIFU is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when the few studies reported are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy. The vast majority of studies refer only to BCR-free survival as end point, thus limiting interpretation of real oncological performance of this technique. Furthermore, side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting.
Another important hot issue in this scenario is the potential benefit that new imaging and diagnosis techniques (MRI, targeted biopsy, PSMA) may add for a more accurate indication. This could provide the possibility of better results for SCAP. The clinical value of this new diagnostic tools is unknown in this scenario and needs to be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCAP | Patients with recurrent prostate cancer undergoing SCAP |
| |
| HIFU | Patients with recurrent prostate cancer undergoing HIFU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local treatment of the prostate (SCAP or HIFU) | Procedure | Once the local involvement of the recurrent prostate cancer is confirmed, patient will undergo local treatment of the prostate (SCAP or HIFU) |
| Measure | Description | Time Frame |
|---|---|---|
| DFS-histology | Disease free survival (confirmed by follow-up biopsy) | 1 year |
| DFS-image | Disease free survival (confirmed by follow-up PET-CT ) | 1 year |
| ADT-FS | Androgen deprivation therapy free survival. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| BCR free survival | Time free of biochemical recurrence (PSA) | 5 years |
| MFS-PET | Metastasis free survival. rate of patients without any metastasis detected on PET-CT. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering local recurrence of prostate cancer after primary treatment with radiation therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ignacio Puche Sanz, MD PhD | Contact | 0034 958 02 00 00 | nacho.puchesanz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ignacio Puche-Sanz, MD, PhD | University Hospital Virgen de las Nieves | Principal Investigator |
| Enrique Gomez-Gomez, MD | Hospital Universitario Reina Sofia de Cordoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire du Cancer | Recruiting | Toulouse | France |
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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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| ID | Term |
|---|---|
| C102196 | SREBP cleavage-activating protein |
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| 5 years f-u |
| Complications rate | Rate of early and long-term complications | 1 year |
| Continence | Change in continence scores (ICIQ-SF q) | 1 year |
| Sexual function | Changes in sexual function (IIEF questionanaire) | 1 year |
| Low urinary tract function | Changes in IPSS questionnaire | 1 year |
| Hospital Universitario Reina Sofía | Recruiting | Córdoba | Andalusia | Spain |
|
| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | Andalusia | Spain |
|
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | Spain |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |