MR-guided Focal Laser Ablation of the Prostate

Prostate Cancer Clinical Trial

Official title:

MR-guided Focal Laser Ablation of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200809
• Other study ID #: 2010/185
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Focal Laser Ablation
• MRI
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• MR-guided focal laser ablation

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Hengelo	Overijssel
Netherlands	Canisius Wilhelmina Hospital	Nijmegen	Gelderland
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	Canisius-Wilhelmina Hospital, Ziekenhuisgroep Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.	36 months.