Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy

Clalit Health Services

Status: Unknown

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03982706

0316-16-RMC

Details and patient eligibility

About

The main objective of this study is to determine whether focal-driven therapies for diagnosis and treatment of prostate cancer are preferable over current clinical methods. Different focal procedures will be examined, including magnetic resonance imaging (MRI)-target biopsy, and focal treatment as High Intensity Focused Ultrasound (HIFU), cryoablation and Nano-Knife.

Full description

Men who are scheduled to undergo a focal therapy will be given patient information sheet, which explains the study in lay terms. Fully informed consent, written or verbal (by phone) will be sought and documented before collecting any research data.

The following information will be collected for all patients:

• Demographic data: date of birth, age, gender, ethnicity, Height, weight.
• Medical History: number and results of previous biopsies, previous Protein Specific Antigen (PSA) tests.

For patients who have undergone or are scheduled to undergo MRI-US FUSION biopsy, the following information will be collected:

• MRI: MRI protocol, MRI results: suspected lesions, apparent diffusion coefficient (ADC) values.
• Biopsy procedure details and results: duration and success of procedure, number of cores taken, pathological results, following treatment (if applicable).

For patients who have undergone or are scheduled to undergo HIFU or Nano-Knife or Cryotherapy the following data will be collected:

• Procedure details.
• Evaluation of success: results of following PSA test, MRI and/or prostate biopsy.

Patients undergoing HIFU, Nano-Knife or Cryotherapy will also be asked to complete two questionnaires: IPSS, a validated lower urinary tract symptom questionnaire, and IIEF, a validated erectile function questionnaire.

Enrollment: 1,000 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men who have underwent, or are scheduled to undergo a focal therapy treatment at Ramat Aviv Medical Center or Rabin Medical Center
2. Age 18-90.

Exclusion criteria

None.

Trial design

1,000 participants in 2 patient groups

MRI-US Fusion

Description:

patients undergoing MRI targeted prostate biopsy

Focal

Description:

patients undergoing focal treatment for localized prostate cancer (HIFU, NanoKnife, Cryotherapy)