Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy
| Registry | NCT05044754, acronym SALVPROST |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 50 (Estimated) |
| Sponsor | University Hospital Virgen de las Nieves (Other); collaborators: Hospital Universitario Reina Sofia de Cordoba, Hospitales Universitarios Virgen del Rocío, Institut Universitaire du Cancer de Toulouse |
| Conditions | Cryotherapy, High Intensity Focused Ultrasounds, Recurrent Prostate Cancer |
| Interventions | Local treatment of the prostate (SCAP or HIFU) (Procedure) |
| Dates | start 2021-10-01 (estimated), primary completion 2023-10-01 (estimated), completion 2024-10-01 (estimated), first posted 2021-09-16, last updated 2021-09-16 |
| Locations | 4 sites in France, Spain |
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All trials for Cryotherapy All trials for High Intensity Focused Ultrasounds All trials of Local treatment of the prostate (SCAP or HIFU)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SCAP | Procedure: Local treatment of the prostate (SCAP or HIFU) | Patients with recurrent prostate cancer undergoing SCAP | |
| HIFU | Procedure: Local treatment of the prostate (SCAP or HIFU) | Patients with recurrent prostate cancer undergoing HIFU |
Sex: Male, ages: 18 Years to 90 Years
Inclusion Criteria: * Patients with local recurrence (with histological confirmation) after treatment with radiotherapy or brachytherapy without evidence of distant involvement evaluated preferably with PET/PSMA (if not available then Fluciclovine PET/CT or choline PET/CT must be performed). * Life expectancy >10 years * Prostate volume < 100cc * PSA<10 ng/mL * mpMRI + fusion/systematic biopsy (template suppl 1) o mpMRI ≤cT3a without affecting the bladder neck or the membranous urethra so that the continence mechanisms of the sphincter are not compromised. Exclusion Criteria: * Patients with clinically confirmed distant metastasis * Any previous major rectal surgery * Clinically significant lower urinary tract or rectal anomalies * Existing urethral, rectal, or bladder fistulae
| Facility | City | Country | Status |
|---|---|---|---|
| Institut Universitaire du Cancer | Toulouse | France | Recruiting |
| Hospital Universitario Reina Sofía | Córdoba, Andalusia | Spain | Recruiting |
| Hospital Universitario Virgen de las Nieves | Granada, Andalusia | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio | Seville | Spain | Recruiting |