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

NCT ID: NCT04421781

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-06-01

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.

Conditions

Prostatic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Salvage HIFU for local recurrence after prostatectomy and 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.

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

Intervention Type: OTHER

Patients were treated using dedicated post-EBRT parameters (5-s pulse, 5-s waiting period, 90% of the acoustic power). 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.

Interventions

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

Patients were treated using dedicated post-EBRT parameters (5-s pulse, 5-s waiting period, 90% of the acoustic power). 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Urology and Transplantation Surgery, Edouard Herriot Hospital,

Lyon, , France

Countries

France

Other Identifiers

20_086

Identifier Type: -

Identifier Source: org_study_id