Cryotherapy, Prostate Cancer, Recurrent Prostate Cancer
Conditions
Keywords
PSMA/PET-CT
Brief summary
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
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.
Interventions
PROCEDURESalvage cryoablation of the prostate (SCAP)
Cryotherapy of the prostate through transperineal freeezing needles
Sponsors
Hospital Universitario Reina Sofia de Cordoba
Ignacio Puche Sanz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free rate | 1 year | absence of disease in follow-up biopsy AND PET/PSMA |
| ADT-free survival | 5 years | Absence of androgen deprivation therapy need during follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on urinary symptoms | 1 year | Measured by International Prostate Symptoms Score (IPSS) and uroflowmetry |
| Biochemical free survival | 5 years | PSA |
| Rate of incontinence | 1 year | Measured by International Consultation on Incontienence Questionnaire short-form (ICIQ-SF) |
| Performance of mpMRI and PET-CT for the detection of clinically significant recurrence. | 1 year | Related to the histopathology observed |
| Rate of metastasis detected by PET-CT | 1 year | Metastais detected |
| Metastasis free survival | 5 years | Metastasis detected in novel imaging modalities |
| Rate of sexual disfunction | 1 year | Measured by International Index Erectile Function (IIEF-25) |
Countries
Spain
Contacts
Primary ContactEnrique Gómez-Gómez
Outcome results
None listed