NL-OMON36226
Recruiting
Phase 2
MR-guided focal laser ablation of the prostate: a pilot study - MR-guided focal laser ablation
niversitair Medisch Centrum Sint Radboud0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- prostate cancer
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria counting for both groups:
- •Newly diagnosed and biopsy proven prostate cancer
- •Low risk patients (PSA \<\= 10 ng/mL, Gleason 3\+3, cT1c \- T2a)
- •No previous treatment for prostate cancer
- •Cancer lesion located at least 2 cm away from the neurovascular bundle
- •according to Multimodality MR images
- •Signed informed consent by patient
- •Age 18 years or older
- •Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia);Additional inclusion criterion for patients in group A:
- •Patients must be scheduled for a radical prostatectomy with a lesion of max 4 cm
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
Phase 2
MRI-guided Focal Laser AblationProstate CancerNCT04379362Radboud University Medical Center53
Recruiting
Not Applicable
MRI Guided Stereotactic Focal Ablation of Prostate CancerProstate CancerCancer - ProstateACTRN12623000902695Austin Health25
Withdrawn
Not Applicable
MR-guided focal cryosurgery of the prostate: a pilot study*Prostate cancerProstate carcinoma100385971003695810025506NL-OMON34160niversitair Medisch Centrum Sint Radboud30
Completed
Not Applicable
MR-guided Focal Laser Ablation of the ProstateProstate CancerMRIFocal Laser AblationNCT02200809Radboud University Medical Center20
Completed
Not Applicable
Transperineal Laser Ablation for Focal Prostate Cancer: Safety and Ablative Efficacy evaluation using post-radical Prostatectomy Histological AnalysisNL-OMON48033Academisch Medisch Centrum15