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

Ignacio Puche Sanz

Status: Enrolling

Conditions: Cryotherapy; Recurrent Prostate Cancer; Prostate Cancer

Treatments: Procedure: Salvage cryoablation of the prostate (SCAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04891536

CRIOAND 0325-N-21

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Patients with histologically confirmed recurrent prostate cancer after primary radiation therapy

Experimental group

Treatment:

Procedure: Salvage cryoablation of the prostate (SCAP)