Salvage HIFU for Local Recurrence in the Prostatic Bed After Prostatectomy and External Beam Radiation Therapy : Preliminary Results

Completed

• Conditions: Prostatic Cancer
• Interventions: Other: Retrospectively review of medical data in patients treated by Salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT

• Registration Number: NCT04421781
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Retrospective monocentric analysis performed on patients treated with salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence will be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-04-01
• Status Verified: 2020-06
• Study Completion: 2020-06-01
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Last Update Submitted: 2020-06-04
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

• patient treated by S-HIFU for a single recurrence within the prostatic bed after an initial RP with curative intent with or without lymphadenectomy followed by salvage or adjuvant EBRT (with or without pelvic lymph node irradiation) combined or not with ADT;

  • life expectancy of ≥10 years;
  • histological local recurrence (positive biopsy),
  • negative metastatic evaluation (All patients underwent multiparametric MRI (mpMRI) to confirm the relapse in the prostatic bed and Choline PET/CT to exclude metastasis (lymph node, visceral or bone metastasis).
  • the use of ADT at BF after S-EBRT was not an exclusion criterion (ADT was introduced by the centre referring the patient).
  • no limits were placed on prostate cancer characteristics, PSA (value, doubling time (PSA-DT)), Gleason score and location of suspected recurrence in relation to the sphincter.

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Exclusion Criteria

• patients who do not meet the inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Salvage HIFU for local recurrence after prostatectomy and EBRT	Retrospectively review of medical data in patients treated by Salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT	Between July 2005 and November 2018, at Edouard Herriot Hospital (Lyon, France), 22 consecutive patients were treated with S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence were retrospectively reviewed.

Primary Outcome Measures

Name	Time	Method
Oncological outcomes in the prostatic bed after S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT.	December 31, 2019	Oncological outcomes: * Treatment failure-free survival: absence of: * recurrent prostate cancer in the prostatic bed and/or; * metastasis and/or; * introduction of systemic treatment; * Progression-free survival: absence of: * metastasis and/or; * introduction of systemic treatment; * decrease in PSA value: any drop in PSA after S-HIFU, regardless of whether there was subsequent PSA progression; * BCR-free survival following S-HIFU defined as an absence of two rises in PSA ≥0.2 ng/mL above nadir; Functional outcomes: * complications (Clavien classification); * Urinary incontinence (Ingelman-Sundberg score)

Trial Locations

Locations (1)

Department of Urology and Transplantation Surgery, Edouard Herriot Hospital,; 🇫🇷 Lyon, France