MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

ConditionsNeoplasms Prostate Cancer of the Prostate

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age50+

SponsorUrological Research Network, LLC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Image Fusion (MR/US) Software Registration Guided Laser Ablation of Prostate Cancer
Device
Subjects diagnosed by a transperineal fusion or random transperineal or random transrectal prostate biopsy. Laser treatment plan generated by biopsy results +/- MRI is uploaded into the device. In procedure suite, a transperineal anesthetic block is conducted following by Bianco - USPTO PCT/US18/24404. On lithotomy a transrectal ultrasound probe is advanced, the prostate scanned. The images are acquired by fusion device. Co-registration is performed by surgeon delimiting boundaries of prostate. Medical device delivers real-time fusion guidance outlining prostate contours, ablation goals and laser introduce location. Surgeon executes plan or adjust as needed. Surgeon activates laser device, performs ablation monitored by medical device in real-time. The fusion device will deliver great perspective between the ablation areas and critical anatomical landmarks such as: NVB, membranous urethra, etc. Patient is dismissed to the recovery room and discharged afterwards

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Primary Oncological Control

Negative CANCER Rate in treated area after fusion biopsy

Time frame

1 Year

Secondary outcomes

Perioperative Outcomes

Rate of Adverse Events and Serious Adverse Events following CTCAE v5 classification

Time frame

90 days

Urinary Function

Rate of AUA symptoms score less than 7 (Scale 0-35).

Time frame

5 years

Sexual Function

Rate of Sexual Inventory for men scores above 15 (Scale 1-25)

Time frame

5 years

Radiological Cancer Control

Rate of Detection of discrete lesions following multi-parametric prostate MRI

Time frame

5 Years

Other outcomes

Rate of Conversion to Whole gland treatment - Salvage Treatment

Conversion to radical surgery or radiation or cryoablation

Time frame

10 years

Rate of development of metastasis

Detection of metastatic disease

Time frame

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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