Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy

Study Overview
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Brief Summary
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The main objective of this project is to establish a shared comprehensive and systematic protocol for a multicenter prospective registry of patients undergoing salvage cryoablation of the prostate (SCAP). Our study hypothesis is that SCAP constitutes an effective and safe approach to treat local prostate cancer recurrence after brachytherapy or external beam radiation therapy (EBRT).

Detailed Description
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Salvage cryoablation of the prostate has been proposed as an alternative to salvage radical prostatectomy, as it has a potentially lower risk of morbidity and equal efficacy. A recent systematic review assessed a total of 32 studies of SCAP (5.513 patients). The overwhelming majority of patients (93%) received whole-gland SCAP. The adjusted pooled analysis for 2-year BCR-free survival for SCAP was 67.49% (95% CI: 61.68-72.81%), and for 5-year BCR-free survival was 50.25% (95% CI: 44.10-56.40%). Nevertheless, the evidence base relating to the use of SCAP is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when these studies 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 only refer to biochemical-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. Due to this lack of evidence, the EAU 2021 Guidelines recommend that SCAP should only be performed in selected patients in experienced centres as part of a clinical trial or well-designed prospective cohort study.

Official Title
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Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy

Conditions
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Cryotherapy, Prostate Cancer, Recurrent Prostate Cancer

Intervention / Treatment
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* Procedure: Salvage cryoablation of the prostate (SCAP)


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 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 ≤cT3a without affecting the bladder neck or the membranous urethra 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with histologically confirmed recurrent prostate cancer after primary radiation therapy<br> | Procedure: Salvage cryoablation of the prostate (SCAP)<br>* Cryotherapy of the prostate through transperineal freeezing needles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free rate | absence of disease in follow-up biopsy AND PET/PSMA | 1 year | 
| ADT-free survival | Absence of androgen deprivation therapy need during follow-up | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of incontinence | Measured by International Consultation on Incontienence Questionnaire short-form (ICIQ-SF) | 1 year | 
| Rate of sexual disfunction | Measured by International Index Erectile Function (IIEF-25) | 1 year | 
| Effect on urinary symptoms | Measured by International Prostate Symptoms Score (IPSS) and uroflowmetry | 1 year | 
| Biochemical free survival | PSA | 5 years | 
| Metastasis free survival | Metastasis detected in novel imaging modalities | 5 years | 
| Performance of mpMRI and PET-CT for the detection of clinically significant recurrence. | Related to the histopathology observed | 1 year | 
| Rate of metastasis detected by PET-CT | Metastais detected | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSMA/PET-CT