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Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy

RECRUITINGN/ASponsored by Ignacio Puche Sanz
Actively Recruiting
PhaseN/A
SponsorIgnacio Puche Sanz
Started2021-05-01
Est. completion2025-05-01
Eligibility
Age18 Years – 90 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04891536

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).

Eligibility

Age: 18 Years – 90 YearsSex: MALEHealthy volunteers accepted
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

Conditions4

CancerCryotherapyProstate CancerRecurrent Prostate Cancer

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