Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy

Prostate Cancer Clinical Trial

— CRIOAND2021  

Official title:

Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04891536
• Other study ID #: CRIOAND 0325-N-21
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 1, 2026

Study information

• Verified date: May 2021
• Source: University Hospital Virgen de las Nieves
• Contact: Enrique Gómez-Gómez
• Phone: 958 56 76 65
• Email: enriquegomezgomez[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy
• Prostate Cancer
• Prostatic Neoplasms
• Recurrent Prostate Cancer

Intervention

Procedure:
• Salvage cryoablation of the prostate (SCAP)
Cryotherapy of the prostate through transperineal freeezing needles

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba	Andalucía
Spain	Hospital Universitario Virgen de las Nieves	Granada	Andalucía

Sponsors (2)

Lead Sponsor	Collaborator
Ignacio Puche Sanz	Hospital Universitario Reina Sofia de Cordoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free rate	absence of disease in follow-up biopsy AND PET/PSMA	1 year
Primary	ADT-free survival	Absence of androgen deprivation therapy need during follow-up	5 years
Secondary	Rate of incontinence	Measured by International Consultation on Incontienence Questionnaire short-form (ICIQ-SF)	1 year
Secondary	Rate of sexual disfunction	Measured by International Index Erectile Function (IIEF-25)	1 year
Secondary	Effect on urinary symptoms	Measured by International Prostate Symptoms Score (IPSS) and uroflowmetry	1 year
Secondary	Biochemical free survival	PSA	5 years
Secondary	Metastasis free survival	Metastasis detected in novel imaging modalities	5 years
Secondary	Performance of mpMRI and PET-CT for the detection of clinically significant recurrence.	Related to the histopathology observed	1 year
Secondary	Rate of metastasis detected by PET-CT	Metastais detected	1 year