Clinical trial · Observational
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
- 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 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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cryotherapy | — | UNRESOLVED | — |
| High Intensity Focused Ultrasounds | — | UNRESOLVED | — |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local treatment of the prostate (SCAP or HIFU) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- SCAP
- description
- Patients with recurrent prostate cancer undergoing SCAP
- interventionNames
- Procedure: Local treatment of the prostate (SCAP or HIFU)
- label
- HIFU
- description
- Patients with recurrent prostate cancer undergoing HIFU
- interventionNames
- Procedure: Local treatment of the prostate (SCAP or HIFU)
Primary outcomes (3)
- measure
- DFS-histology
- timeFrame
- 1 year
- description
- Disease free survival (confirmed by follow-up biopsy)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available