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MRI-guided Focal Laser Ablation (Unicorn)

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Focal laser ablation

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Focal laser ablation

Eligibility Criteria

45 Years - 76 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

RadboudumcRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low or intermediate grade prostate cancer

Arm Description

Outcomes

Primary Outcome Measures

Urine incontinence incontinence

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 Outcome Measures

Local cancer control

To assess the safety outcome local cancer control achieved at the ablation site after FLA by multiparametric MR imaging and targeted prostate biopsies.

International Prostate Symptom Score (IPSS)

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)

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)

International Consultation on Incontinence Questionnaire (ICIQ)

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).

Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25

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

To evaluate the complication rate related to the technique

Full Information

NCT ID

NCT04379362

First Posted

April 23, 2020

Last Updated

September 21, 2021

Sponsor

Radboud University Medical Center

Collaborators

Biolitec, Soteria Medical, Siemens Corporation, Corporate Technology

1. Study Identification

Unique Protocol Identification Number

NCT04379362

Brief Title

MRI-guided Focal Laser Ablation

Acronym

Unicorn

Official Title

Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 14, 2018 (Actual)

Primary Completion Date

July 1, 2022 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

Collaborators

Biolitec, Soteria Medical, Siemens Corporation, Corporate Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Magnetic resonance imaging-guided focal laser ablation of prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Focal laser ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Single-center, interventional treatment, non-randomized, open label, single arm, phase II study with a medical device.

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low or intermediate grade prostate cancer

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Focal laser ablation

Intervention Description

Focal laser ablation

Primary Outcome Measure Information:

Title

Urine incontinence incontinence

Description

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).

Time Frame

At inclusion, 3 months, 6 months, 12 months and 24 months follow up.

Secondary Outcome Measure Information:

Title

Local cancer control

Description

To assess the safety outcome local cancer control achieved at the ablation site after FLA by multiparametric MR imaging and targeted prostate biopsies.

Time Frame

At inclusion , 3 months, 6 months, 12 months and 24 months follow up.

Title

International Prostate Symptom Score (IPSS)

Description

Time Frame

At inclusion, 3 months, 6 months, 12 months and 24 months follow up.

Title

Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)

Description

Time Frame

At inclusion, 3 months, 6 months, 12 months and 24 months follow up.

Title

International Consultation on Incontinence Questionnaire (ICIQ)

Description

Time Frame

At inclusion, 3 months, 6 months, 12 months and 24 months follow up.

Title

Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25

Description

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).

Time Frame

At inclusion , 3 months, 6 months, 12 months and 24 months follow up.

Title

Complication rate

Description

To evaluate the complication rate related to the technique

Time Frame

At inclusion , 3 months, 6 months, 12 months and 24 months follow up.

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Gender identity

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

76 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Annemarijke van Luijtelaar, MD

Phone

+31 (0)24 365 22 79

Annemarijke.vanLuijtelaar@radboudumc.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Joyce Bomers, PhD

Phone

+31 (0)24 365 22 79

Joyce.Bomers@radboudumc.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jurgen Fütterer, MD, PhD

Organizational Affiliation

Radboudumc Nijmegen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michiel Sedelaar, MD, PhD

Organizational Affiliation

Radboudumc Nijmegen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radboudumc

City

Nijmegen

ZIP/Postal Code

6500 HB

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Annemarijke van Luijtelaar, MD

Phone

+31 (0)24 365 22 79

Annemarijke.vanLuijtelaar@radboudumc.nl

First Name & Middle Initial & Last Name & Degree

Joyce Bomers, PhD

Phone

+31 (0)24 365 22 79

Joyce.Bomers@radboudumc.nl

First Name & Middle Initial & Last Name & Degree

Jurgen Fütterer, MD, PhD

First Name & Middle Initial & Last Name & Degree

Michiel Sedelaar, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The investigators will be author of submitted manuscripts in case they fulfill criteria for authorship according to regulations of scientific journals. After scientific publication of the results the study protocol, relevant data and findings will be made publically available for other centers to implement (parts) of this research into their standard clinical practice if they wish to do so.

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MRI-guided Focal Laser Ablation

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