MR-guided Focal Laser Ablation of the Prostate | NCT02200809

Studies
MR-guided Focal Laser Ablation of the Prostate

NCT02200809

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Apr 24, 2020Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Prostate Cancer
MRI
Focal Laser Ablation

Interventions

MR-guided focal laser ablation

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014Actual

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Jul 21, 2014

First Submission Date that Met QC Criteria

Jul 24, 2014

First Posted Date

Jul 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2020

Last Update Posted Date

Apr 24, 2020Actual

Name	Class
Canisius-Wilhelmina Hospital	OTHER
Ziekenhuisgroep Twente	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
MR-guided focal laser ablation	Experimental		Device: MR-guided focal laser ablation

Name	Type	Description	Arm Group Labels	Other Names
MR-guided focal laser ablation	Device		MR-guided focal laser ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jurgen Futterer, MD, PhD	Radboud University Nijmegen Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboud University Medical Center		Nijmegen	Gelderland	6500 HB	Netherlands
Canisius Wilhelmina Hospital

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided