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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT04421781
Collaborator
(none)
22
1
3
7.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Design

Study Type:
Observational
Actual Enrollment :
22 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Salvage HIFU for Local Recurrence in the Prostatic Bed After Prostatectomy and External Beam Radiation Therapy : Preliminary Results
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 86 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Exclusion Criteria:
  • patients who do not meet the inclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Urology and Transplantation Surgery, Edouard Herriot Hospital, Lyon France

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04421781
Other Study ID Numbers:
  • 20_086
First Posted:
Jun 9, 2020
Last Update Posted:
Jun 9, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2020