Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Cryotherapy; Recurrent Prostate Cancer
• Interventions: Procedure: Salvage cryoablation of the prostate (SCAP)

• Registration Number: NCT04891536
• Lead Sponsor: Ignacio Puche Sanz

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.

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05-01
• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Study First Posted: 2021-05-18
• Last Update Posted: 2021-05-18
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with histologically confirmed recurrent prostate cancer after primary radiation therapy	Salvage cryoablation of the prostate (SCAP)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate of incontinence	1 year	Measured by International Consultation on Incontienence Questionnaire short-form (ICIQ-SF)
Rate of sexual disfunction	1 year	Measured by International Index Erectile Function (IIEF-25)
Biochemical free survival	5 years	PSA
Effect on urinary symptoms	1 year	Measured by International Prostate Symptoms Score (IPSS) and uroflowmetry
Metastasis free survival	5 years	Metastasis detected in novel imaging modalities
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

Trial Locations

Locations (2)

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Andalucía, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Andalucía, Spain