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MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

Office Based MRI/Ultrasound Guided Prostate Cancer Ablation: Outcomes Registry

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "It aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer."
  • "CLINICAL REGISTRY OBSERVATION NATURE This serves as a registration trial evaluating short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer."
  • "ONCOLOGIC - In addition to primary aim, determine risk and rate of emergence of de-novo tumors (so called Outfield Recurrence) at the 1 year fusion biopsy mark and overtime."
  • "Moreover, the investigators will evaluate the impact of MRI in assessing tumor locations and of software registration guiding the location and extent of ablation of the laser ablation over fixed time intervals."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This serves as a registration trial. It aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. Outcomes will be categorized as: 1- Procedure Related, 2- Perioperative - Adverse Events that may occur within 90 days, 3-Oncologic: Recurrence of cancer in treatment area, de-novo tumors, conversion to radical surgery, radiation or cryoablation, emergence of metastasis, 4- Functional: Sexual and Urinary function following treatment

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Men between 50 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 sites (1)

FL