RecruitingNot ApplicableNCT04891536

Salvage Cryotherapy for Recurrent Prostate Cancer After Radiation Therapy

Salvage Cryotherapy for Recurrent Prostate Cancer After Brachytherapy or Radiotherapy


Sponsor

Ignacio Puche Sanz

Enrollment

100 participants

Start Date

May 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating cryotherapy (freezing the prostate) as a salvage treatment for men whose prostate cancer has come back in the prostate after they previously received radiation therapy or brachytherapy (internal radiation seeds). **You may be eligible if...** - Your prostate cancer has come back locally (confirmed by biopsy) after radiation or brachytherapy - Imaging (PET/PSMA scan) shows no signs of cancer spread to other parts of the body - Your PSA level is below 10 ng/mL - Your prostate volume is under 100 cc - Your expected survival is more than 10 years - Your cancer on MRI is staged no higher than cT3a and does not involve the bladder neck or urethra **You may NOT be eligible if...** - You have confirmed cancer spread to distant areas - You have had major rectal surgery - You have significant problems with the lower urinary tract or rectum - You already have a fistula (abnormal connection) between the urethra, rectum, or bladder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESalvage cryoablation of the prostate (SCAP)

Cryotherapy of the prostate through transperineal freeezing needles


Locations(2)

Hospital Universitario Reina Sofía

Córdoba, Andalusia, Spain

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, Spain

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NCT04891536


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