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

NCT04421781 | Completed

• 1 other identifier: 20_086
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

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 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.

Salvage HIFU for local recurrence after prostatectomy and EBRT

Eligibility Criteria

• Age: 60 Years - 86 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 radical prostatectomy and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence were retrospectively reviewed.

You may qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Department of Urology and Transplantation Surgery, Edouard Herriot Hospital,

Lyon, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: March 1, 2020
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

FR (1)