Primary: To evaluate local tumour control by using HIFU technology.Secondary: To evaluate treatment toxicity, disease progression and QoL.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints
Main study parameter
Local tumour control: Twelve month's after salvage HIFU treatment local tumour
control will be evaluated by performing MRI and taking prostate biopsies.
Secondary outcome
Biochemical and clinical progression: During 12 month*s PSA and health
condition will be controlled and complaint related examinations such as bone
scan or computer tomography (CT) will take place if necessary. Biochemical
progression is defined as PSA nadir plus 2 (Phoenix criteria).
Background summary
In radiation treated prostate cancer local recurrence rates remain
high and standard treatment consists of palliative medical androgen blockade.
Anti-hormonal treatment frequently fails to be curative and patients of any age
will end in castration resistant disease en suffer from disease progression.
Furthermore, side effects of androgen blockade worsen the QoL of these
patients.
Salvage-HIFU treatment of recurrent prostate cancer has shown to be
feasible and able to control local tumour progression with moderate side
effects.
The efficacy of the Focal One® device (EDAP TMS) using robot assistance
and MRI fusion during prostate treatment is investigated in patients with
radiation failure and locally recurrent prostate cancer.
Study objective
Primary: To evaluate local tumour control by using HIFU technology.
Secondary: To evaluate treatment toxicity, disease progression and QoL.
Study design
Prospective single arm national multicentre study.
Intervention
Local treatment of recurrent prostate cancer with high intensity focal
ultrasound using the Focal One® device (EDAP TMS).
Study burden and risks
Rectal fistula, urinairy infections, incontinency
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria
Histologically proven recurrent prostate cancer any Gleason score History of EBRT
PSA * 20
iPSA * 30 (PSA before EBRT)
Maximum prostate height * 54 mm
WHO performance status < 2
Written informed consent
Exclusion criteria
Anti-hormonal treatment within 12 month before study entry
Lymph node or bone metastasis (positive CT/bone scan or histologically proven) Low- or high-dose rate brachytherapy
Previous HIFU treatment
Inability to comply with the treatment protocol
Hip prosthesis, pacemaker / ICD (contraindication for MRI)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49290.098.14 |