Clinical trial · Interventional
Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy
Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy
NCT04891536CI-TRIAL-00051853CRIOAND2021unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cryotherapy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Salvage cryoablation of the prostate (SCAP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with histologically confirmed recurrent prostate cancer after primary radiation therapy
- interventionNames
- Procedure: Salvage cryoablation of the prostate (SCAP)
Primary outcomes (2)
- measure
- Disease-free rate
- timeFrame
- 1 year
- description
- absence of disease in follow-up biopsy AND PET/PSMA
- measure
- ADT-free survival
- timeFrame
- 5 years
- description
- Absence of androgen deprivation therapy need during follow-up
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.