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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

Prostate CancerRecurrent Prostate CancerCryotherapy

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

Inclusion Criteria5

  • 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 Criteria4

  • 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

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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