MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Urological Research Network, LLC
Study ID
NCT02381990
Status
Recruiting
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Conditions

  • Cancer of the Prostate
  • Neoplasms Prostate

Eligibility Criteria

Sex
MALE
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY — PROCEDURE
    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

Study Details

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.

Key Dates

Start date
Aug 31, 2013
Status verified
Jan 2023
Primary completion
Aug 31, 2023
Completion
Aug 31, 2033

Study Design

Enrollment
5,000 participants (estimated)

Primary Outcome Measure

Oncological Control [ Time Frame: 1 Year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Urological Research NetworkMiami LakesFlorida33016
CIELO D GUERRA, BS
[email protected]
305-515-9887
FERNANDO J BIANCO, MD (PRINCIPAL_INVESTIGATOR)
EDWARD L GHEILER, MD (SUB_INVESTIGATOR)
ARIEL M KAUFMAN, MD (SUB_INVESTIGATOR)
EUSEBIO J LUNA, MD (SUB_INVESTIGATOR)

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Urological Research Network· Miami Lakes, FL

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