Recruiting

Cryotherapy

Sponsor:

Urological Research Network, LLC

Code:

NCT02381990

Conditions

Neoplasms Prostate

Cancer of the Prostate

Eligibility Criteria

Sex: Male

Age: 55+

Healthy Volunteers: Not accepted

Interventions

FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

Study Details

Brief summary:

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.

Conditions

Neoplasms Prostate

Cancer of the Prostate

Study ID

NCT02381990

Start date

Aug, 2013

Status verified date

Jan, 2023

Completion date

Aug, 2033

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Absence of regional or distant metastatic disease
  • Multiparametric MRI of the prostate performed either before the biopsy or >10 weeks after prostate biopsy
  • Treated with Cryotherapy of the prostate
  • Treatment based on co-registration between MP-MRI and Prostate Ultrasound

Exclusion Criteria:

  • Prior treatment of prostate cancer in the form of surgery.
  • Performance status greater than 0 based on ECOG criteria
  • Mental status impairment

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Interventions

FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

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

Primary outcome measure

  • Oncological Control [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

CIELO D GUERRA, BS

305-515-9887CIELO@BESTUROLOGY.NET

LUANDA SIANO, PA

305-822-7227LUANDA@BESTUROLOGY.NET

Locations

Urological Research Network

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

CIELO D GUERRA, BS

305-515-9887CIELO@BESTUROLOGY.NET

Principal Investigator:

FERNANDO J BIANCO, MD

More Information

Sponsor

Urological Research Network, LLC

Last update posted

Jan 26, 2023

Last verified

Jan, 2023

Keywords

  • Prostate
  • PSA
  • FUSION
  • Ultrasound
  • MRI
  • Cancer
  • Cryotherapy
  • Outcomes
  • Recurrence
  • QOL, Quality of Life
  • Urinary function
  • Sexual Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Urological Research Network, LLC on 2023-01-26.