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

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.

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Key information

Conditions

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

Age range

60 year–86 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Urology and Transplantation Surgery, Edouard Herriot Hospital,

Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Oncological outcomes in the prostatic bed after S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT.

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: Salvage HIFU

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jun 9, 2020
Registry last updated: Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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