Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy
CRIOAND2021
1 other identifier
interventional
100
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started May 2021
Typical duration for not_applicable prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 9, 2021
CompletedFirst Posted
Study publicly available on registry
May 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMay 18, 2021
May 1, 2021
4 years
May 9, 2021
May 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
Rate of incontinence
1 year
Rate of sexual disfunction
1 year
Effect on urinary symptoms
1 year
Biochemical free survival
5 years
Metastasis free survival
5 years
- +2 more secondary outcomes
Study Arms (1)
Patients with histologically confirmed recurrent prostate cancer after primary radiation therapy
EXPERIMENTALInterventions
Cryotherapy of the prostate through transperineal freeezing needles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ignacio Puche Sanzlead
- Hospital Universitario Reina Sofia de Cordobacollaborator
Study Sites (2)
Hospital Universitario Reina Sofía
Córdoba, Andalusia, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
May 9, 2021
First Posted
May 18, 2021
Study Start
May 1, 2021
Primary Completion
May 1, 2025
Study Completion
May 1, 2026
Last Updated
May 18, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share