MRI/Ultrasound Fusion Guided Prostate Cryotherapy

ConditionsNeoplasms Prostate Cancer of the Prostate

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age55+

SponsorUrological Research Network, LLC

About this trial

Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and <50% positive core rate by prostate lobe

Men older than 65 years of age with clinical diagnosis of prostate cancer <50% positive core rate by prostate lobe

Absence of extra-capsular extension

Absence of seminal vesicle invasion

Disqualifiers

Prior treatment of prostate cancer in the form of surgery.

Performance status greater than 0 based on ECOG criteria

Mental status impairment

Trial population

As written in Initial Section

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY
Procedure/Surgery
Biopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic "cryoprobes/devices" are employed to freeze and all "circuled or noted" cancer lesions. Two freeze 8 min/ thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Oncological Control

Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy

Time frame

1 Year

Secondary outcomes

Oncological Control

Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy

Time frame

1 Year

Oncological Control

Lack of prostate cancer presence in gland measured by MP-MRI

Time frame

Yearly, up to 10 years

Urinary Functional Outcomes

Evaluation of urinary function outcomes when compared to baseline using expanded prostate composite index and AUA symptoms scores. Urinary function also by objective measurements - uroflow and post void residuals

Time frame

Every 3 months up to 24 months

Perioperative Outcomes

Procedure tolerance, need for hospital admission or ER consultation, incidence of urinary tract infection, urinary retention, any significant side effect that may occur and perioperative survivel

Time frame

30 days

Other outcomes

Secondary Treatment Requirement

Type of treatments required after initial intervention over time

Time frame

Yearly, up to 10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Urological Research Network, LLC

Lead sponsor

Source ClinicalTrials.gov

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