CRIOAND2021: Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy

• Sponsor: Ignacio Puche Sanz (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04891536
• Collaborator: Hospital Universitario Reina Sofia de Cordoba (Other)
• Enrollment: 100
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 60
• Patients Per Site: 50
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Cryotherapy; Recurrent Prostate Cancer	Procedure: Salvage cryoablation of the prostate (SCAP)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Disease-free rate [1 year]

   absence of disease in follow-up biopsy AND PET/PSMA

2. ADT-free survival [5 years]

   Absence of androgen deprivation therapy need during follow-up

Secondary Outcome Measures

1. Rate of incontinence [1 year]

   Measured by International Consultation on Incontienence Questionnaire short-form (ICIQ-SF)

2. Rate of sexual disfunction [1 year]

   Measured by International Index Erectile Function (IIEF-25)

3. Effect on urinary symptoms [1 year]

   Measured by International Prostate Symptoms Score (IPSS) and uroflowmetry

4. Biochemical free survival [5 years]

   PSA

5. Metastasis free survival [5 years]

   Metastasis detected in novel imaging modalities

6. Performance of mpMRI and PET-CT for the detection of clinically significant recurrence. [1 year]

   Related to the histopathology observed

7. Rate of metastasis detected by PET-CT [1 year]

   Metastais detected

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Reina Sofía	Córdoba	Andalucía	Spain
2	Hospital Universitario Virgen de las Nieves	Granada	Andalucía	Spain

Sponsors and Collaborators

• Ignacio Puche Sanz
• Hospital Universitario Reina Sofia de Cordoba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ignacio Puche Sanz, MD PhD, University Hospital Virgen de las Nieves
• ClinicalTrials.gov Identifier: NCT04891536
• Other Study ID Numbers: CRIOAND 0325-N-21
• First Posted: May 18, 2021
• Last Update Posted: May 18, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Ignacio Puche Sanz, MD PhD, University Hospital Virgen de las Nieves: PSMA/PET-CT
• Additional relevant MeSH terms: Prostatic Neoplasms; Recurrence

Study Results

No Results Posted as of May 18, 2021