Prostate Cancer
Conditions
Keywords
Focal laser ablation
Brief summary
Magnetic resonance imaging-guided focal laser ablation of prostate cancer.
Interventions
PROCEDUREFocal laser ablation
Focal laser ablation
Sponsors
Biolitec
Soteria Medical
Siemens Corporation, Corporate Technology
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-center, interventional treatment, non-randomized, open label, single arm, phase II study with a medical device.
Eligibility
Sex/Gender
MALE
Age
45 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging); * Maximum MRI visible lesion size is ≤ 15 mm large axis; * Life expectancy at inclusion of more 10 years; * Diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore MRI guided biopsies; * Criteria of low and intermediate risk of progression and eligibility for focal therapy (clinical stage of maximum T2c, maximum biopsy Gleason score of 4 + 3 on targeted biopsies, serum prostate specific antigen \< 15 ng/ml); * Patient accepting to be included in an active surveillance protocol at the end of the study, in accordance with the recommendations of good practice.
Exclusion criteria
* History of prostate surgery; * History of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis; * History of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer); * Severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score \> 18; * Tumor with MRI signs of extra-capsular extension or invasion of the seminal vesicles; * Maximum cancer core length \>3 mm and/or maximum Gleason score of 3+4 on systematic biopsies outside the visible tumor area on mpMRI; * Impossibility to obtain a valid informed consent; * Patients unable to undergo MR imaging, including those with contra-indications; * Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection); * Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging; * Patients with evidence for nodal or metastatic disease; * Patients with an estimated Glomerular Filtration Ratio (eGFR) \< 40 mL/min/1.73 m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine incontinence incontinence | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. International Prostate Symptom Score (IPSS) |
| Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF) | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF) |
| Local cancer control | At inclusion , 3 months, 6 months, 12 months and 24 months follow up. | To assess the safety outcome local cancer control achieved at the ablation site after FLA by multiparametric MR imaging and targeted prostate biopsies. |
| Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25 | At inclusion , 3 months, 6 months, 12 months and 24 months follow up. | To evaluate quality of life before and after FLA in men with prostate cancer by using a validated quality of life questionnaire (EORTC QLQ PR25). |
| Complication rate | At inclusion , 3 months, 6 months, 12 months and 24 months follow up. | To evaluate the complication rate related to the technique |
| International Consultation on Incontinence Questionnaire (ICIQ) | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. the International Consultation on Incontinence Questionnaire (ICIQ). |
Countries
Netherlands
Contacts
Primary ContactAnnemarijke van Luijtelaar, MD
Backup ContactJoyce Bomers, PhD
Outcome results
None listed