MR-guided Focal Laser Ablation of the Prostate

Radboud University Medical Center

Status

Completed

Conditions

MRI

Prostate Cancer

Focal Laser Ablation

Treatments

Device: MR-guided focal laser ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT02200809

2010/185

Details and patient eligibility

About

Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.

Enrollment

20 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Newly diagnosed and biopsy proven prostate cancer
Intermediate risk patients (PSA <= 20 ng/mL, Gleason ≤ 7, T2b)
No previous treatment for prostate cancer
Cancer lesion located at least 1 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)

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