SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Cryotherapy, High Intensity Focused Ultrasounds, Recurrent Prostate Cancer

Intervention / Treatment
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* Procedure: Local treatment of the prostate (SCAP or HIFU)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SCAP<br>Patients with recurrent prostate cancer undergoing SCAP | Procedure: Local treatment of the prostate (SCAP or HIFU)<br>* Once the local involvement of the recurrent prostate cancer is confirmed, patient will undergo local treatment of the prostate (SCAP or HIFU)<br>|
| HIFU<br>Patients with recurrent prostate cancer undergoing HIFU | Procedure: Local treatment of the prostate (SCAP or HIFU)<br>* Once the local involvement of the recurrent prostate cancer is confirmed, patient will undergo local treatment of the prostate (SCAP or HIFU)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |