Assessment of disease control, and genito-urinary and rectal side effects, in patients with localized prostate cancer, 24 months after focal IRE therapy.
ID
Source
Brief title
Condition
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Assessment of urinary incontinence in patients with localized PCa, 24 months
after focal IRE therapy, measured by EPIC-26 questionnaire.
Secondary outcome
- Assessment of genito-urinary and rectal side effects in patients with
localized PCa after focal IRE therapy, measured by IPSS-QoL, EPIC-26, IIEF-15,
EQ-5D, EORTC-QLQ-C30&PR25, SHIM, HADS, ICIQ and WAI.
- Assessment of disease control in patients with localized PCa after focal IRE
therapy, measured by mp-MRI 12 months after IRE therapy, by re-biopsy after 12
months, and by periodic PSA testing.
- Assessment of the utilization of mp-MRI in patients with localized PCa after
focal IRE therapy, to evaluate ablation zone periodically, by mpMRI after 12
months.
- Assessment of complications in patients with localized PCa after focal IRE
therapy, measured by the Clavien-Dindo classification of surgical
complications.
Background summary
Yearly, 11.000 men are diagnosed with prostate cancer (PCa) in the Netherlands.
Mostly, men are diagnosed with localized disease. Focal therapy is a novel
alternative to current, widely-used, radical whole-gland therapies (radical
prostatectomy or radiotherapy). Radical therapy significantly reduces long-term
functional outcomes, leading to detrimental results on quality of life.
Irreversible electroporation (IRE) therapy is an emerging focal therapy,
relying on a non-thermal mechanism to induce cell-death. Early clinical outcome
in literature shows low impact on continence and potency. Oncological outcomes
on short-term are good, but long-term follow up has yet to be evaluated.
Study objective
Assessment of disease control, and genito-urinary and rectal side effects, in
patients with localized prostate cancer, 24 months after focal IRE therapy.
Study design
Prospective, single-arm intervention study.
Intervention
Patients will undergo IRE as focal treatment for PCa.
Study burden and risks
The nature and extent of burden associated with participation consists of 3-4
extra visits to the hospital.
- Patients will firstly visit extra for inclusion. Patients will fill out
questionnaires a total of six times.
- If not performed yet, before IRE treatment, patients will have to undergo
Transperineal Template-guided biopsies (TTMB) of the prostate for adequate
tumour localisation.
- Subsequently, patients will undergo focal IRE ablation therapy, planned as an
overnight-stay procedure, under general anaesthetics.
- In concordance with the Active Surveillance protocol, after 12 months,
patients will undergo another mpMRI and after 12 months another prostate biopsy
session, to guarantee adequate disease control.
Lifelong periodic control, including PSA measurement, will be performed for PCa
regardless of the study.
Potential benefits for the patients are better long-term functional outcome
results and equal oncological outcome results compared to whole-gland radical
therapy of PCa. Earlier described risks of participation and IRE treatment are
transient haematuria, urinary tract infection/urosepsis, (worsening of)
erectile dysfunction, (worsening of) lower urinary tract symptoms, urinary
retention, perineal hematoma, or urethra damage or rectal damage. When PCa is
not properly treated with focal therapy, patients might undergo an additional
IRE procedure or a radical treatment eventually. Based on the currently
available publications on IRE therapy and target biopsy of the prostate the
risk of complications is estimated to be low.
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following
criteria:
- Signed written informed consent
- Age >40 years, and life expectancy of *10 years.
- Serum PSA <15ng/mL.
- Histologically proven low- to intermediate-risk PCa (i.e. Gleason *7 with max 3+4<=7).
- Localized disease (i.e. no extracapsular extension, vesiculae seminalis invasion or suspected metastasis).
- Stage radiological *T2cN0M0 on mp-MRI, with *1 visible and histology proven lesion(s) in the prostate (PI-RADS 3-5). Co-existing MRI-unvisible Gleason 6 disease is no exclusion
- Prostatic lesion visible on mp-MRI, accessible for IRE with a maximum diameter of 20mm in the transversal plane.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation
in this study:
- Patients who are unwilling to sign written informed consent
- Patients with ASA *4
- Patients with evidence of lesions in contact with the prostatic capsule on mpMRI.
- Patients with evidence of metastatic or nodal disease outside the prostate on mpMRI.
- Patients with GS >7.
- Patient with capsular contact of tumour *6mm in the prostate.
- Patients with previous treatment for PCa.
- Patients with a history of radiotherapy to the pelvis.
- Patients with a history of androgen suppression/hormonal therapy.
- Patients unable to undergo a TRUS.
- Patients who meet exclusion criteria for MRI following the protocol of the radiology department of the St. Antonius Hospital.
- Patients fulfilling the exclusion criteria for the Gadovist gadolinium (Glomerular Filtration Rate (GFR) of < 30 mL/min/1.73m2.
- Patients who underwent a transurethral resection of the prostate (TURP) or stenting of the prostate.
- Patients with bleeding disorders or the inability to stop anticoagulant or antiplatelet therapy.
- Patients with heart arrhythmia or an ICD or Pacemaker.
Design
Recruitment
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 | NL64381.100.17 |