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

Prostatic Cancer Clinical Trial

— Salvage HIFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421781
• Other study ID #: 20_086
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years to 86 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
France	Department of Urology and Transplantation Surgery, Edouard Herriot Hospital,	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oncological outcomes in the prostatic bed after S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT.	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)	December 31, 2019