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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Cryotherapy of the prostate through transperineal freeezing needles
Hospital Universitario Reina Sofía
Córdoba, Andalusia, Spain
RECRUITINGHospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
RECRUITINGDisease-free rate
absence of disease in follow-up biopsy AND PET/PSMA
Time frame: 1 year
ADT-free survival
Absence of androgen deprivation therapy need during follow-up
Time frame: 5 years
Rate of incontinence
Measured by International Consultation on Incontienence Questionnaire short-form (ICIQ-SF)
Time frame: 1 year
Rate of sexual disfunction
Measured by International Index Erectile Function (IIEF-25)
Time frame: 1 year
Effect on urinary symptoms
Measured by International Prostate Symptoms Score (IPSS) and uroflowmetry
Time frame: 1 year
Biochemical free survival
PSA
Time frame: 5 years
Metastasis free survival
Metastasis detected in novel imaging modalities
Time frame: 5 years
Performance of mpMRI and PET-CT for the detection of clinically significant recurrence.
Related to the histopathology observed
Time frame: 1 year
Rate of metastasis detected by PET-CT
Metastais detected
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Time frame: 1 year