Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy (CRIOAND2021)

Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy

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).

Study Overview

• Status: Recruiting
• Conditions: Recurrent Prostate Cancer; Prostate Cancer; Cryotherapy
• Intervention / Treatment: Procedure: Salvage cryoablation of the prostate (SCAP)

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enrique Gómez-Gómez; Phone Number: 958 56 76 65; Email: enriquegomezgomez@yahoo.es

Study Locations

• Spain
  • Andalucía
    • Córdoba, Andalucía, Spain
      • Recruiting
      • Hospital Universitario Reina Sofía
      • Contact: Enrique Gómez-Gómez; Phone Number: 958 56 76 65; Email: enriquegomezgomez@yahoo.es
      • Principal Investigator: Enrique Gómez-Gómez
    • Granada, Andalucía, Spain
      • Recruiting
      • Hospital Universitario Virgen de las Nieves
      • Contact: Ignacio Puche-Sanz; Phone Number: 958 67 56 37; Email: nacho.puchesanz@gmail.com
      • Principal Investigator: Ignacio Puche-Sanz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ignacio Puche Sanz
• Collaborators: Hospital Universitario Reina Sofia de Cordoba

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: PSMA/PET-CT
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: CRIOAND 0325-N-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No