NCT05044754

SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy

Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University Hospital Virgen de las Nieves · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cryotherapy
• High Intensity Focused Ultrasounds
• Recurrent Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Local treatment of the prostate (SCAP or HIFU)	Once the local involvement of the recurrent prostate cancer is confirmed, patient will undergo local treatment of the prostate (SCAP or HIFU)

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-10-01
• Completion: 2024-10-01
• First posted: 2021-09-16
• Last updated: 2021-09-16

Locations

4 sites across 2 countries: France, Spain