Status:
RECRUITING
Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy
Lead Sponsor:
Ignacio Puche Sanz
Collaborating Sponsors:
Hospital Universitario Reina Sofia de Cordoba
Conditions:
Prostate Cancer
Cryotherapy
Eligibility:
MALE
18-90 years
Phase:
NA
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 (SC...
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 revie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04891536
Start Date
May 1 2021
End Date
May 1 2026
Last Update
May 18 2021
Active Locations (2)
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1
Hospital Universitario Reina Sofía
Córdoba, Andalusia, Spain
2
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain