Clinical trial NCT04891536: Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy
Official title: Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Cryotherapy
Recurrent Prostate Cancer
Keywords: PSMA/PET-CT
Lead sponsor: University Hospital Virgen de las Nieves
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Reina Sofia de Cordoba
First posted: 2021-05-18
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free rate
timeFrame: 1 year
measure: ADT-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Rate of incontinence
timeFrame: 1 year
measure: Rate of sexual disfunction
timeFrame: 1 year
measure: Effect on urinary symptoms
timeFrame: 1 year
measure: Biochemical free survival
timeFrame: 5 years
measure: Metastasis free survival
timeFrame: 5 years
measure: Performance of mpMRI and PET-CT for the detection of clinically significant recurrence.
timeFrame: 1 year
measure: Rate of metastasis detected by PET-CT
timeFrame: 1 year
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
state: Andalucía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
state: Andalucía
Study officials:
References: