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MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

RECRUITINGSponsored by Urological Research Network, LLC
Actively Recruiting
SponsorUrological Research Network, LLC
Started2020-11-15
Est. completion2025-11
Eligibility
Age50 Years+
SexMALE
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Age: 50 Years+Sex: MALEHealthy volunteers accepted
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

Conditions3

CancerCancer of the ProstateNeoplasms Prostate

Locations1 site

Urological Research Network
Miami Lakes, Florida, 33016
CIELO D GUERRA, BS305-515-9887CIELO@BESTUROLOGY.NET

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