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Recruiting

NCT Number: NCT05241236

MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

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

Recruiting

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Key information

Conditions

Neoplasms Prostate Cancer of the Prostate Disease Attributes Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Urological Research Network

Miami Lakes, Florida, 33016, United States

Location status: Recruiting

Location contact

ALBERTO LOPEZ-PRIETO, MD

SUB_INVESTIGATOR

ARIEL M KAUFMAN, MD

SUB_INVESTIGATOR

CIELO D GUERRA, BS

CONTACT

[email protected]

305-515-9887

DAYRON RODRIGUEZ, MD

SUB_INVESTIGATOR

EDWARD L GHEILER, MD

SUB_INVESTIGATOR

EUSEBIO J LUNA, MD

SUB_INVESTIGATOR

FERNANDO J BIANCO, MD

PRINCIPAL_INVESTIGATOR

JUAN I MARTINEZ-SALAMANCA, MD

SUB_INVESTIGATOR

SIMON PAZ, MD

SUB_INVESTIGATOR

About this study

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. The primary outcome measure is 1-year oncological control of the targeted ablated area. The following secondary aims are sought: PROCEDURE RELATED: tolerability, feasibility, pain during this office-based procedure. PERIOPERATIVE: Adverse Events (AEs) and Series AEs profile during the initial 90 days after the procedure. 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. Will also observe rate of progression locally and systemically. Conversion to whole gland treatment - surgery extraction, radiation or whole gland cryoablation is of particular interest as is the initiation of androgen suppression (castration). 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. Finally, incidence of metastatic disease - non castrate and castrate - as well as cancer specific and overall survival at 5, 10 and 15 years post procedure. FUNCTIONAL OUTCOMES - determine urinary function and sexual function including incidence of ejaculation, and climacturia at months 3, 6 and 12. These outcomes will then measured yearly for the extent of the study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Intervention of Interest: Prostate Cancer Laser Ablation

Primary outcomes

  1. Primary Oncological Control

    Time frame: 1 Year

    Negative CANCER Rate in treated area after fusion biopsy

Secondary outcomes

  1. Perioperative Outcomes

    Time frame: 90 days

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

  2. Urinary Function

    Time frame: 5 years

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

  3. Sexual Function

    Time frame: 5 years

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

  4. Radiological Cancer Control

    Time frame: 5 Years

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

Other outcomes

  1. Rate of Conversion to Whole gland treatment - Salvage Treatment

    Time frame: 10 years

    Conversion to radical surgery or radiation or cryoablation

  2. Rate of development of metastasis

    Time frame: 10 years

    Detection of metastatic disease

Study contacts

Contact information is provided by the study sponsor or research team.

CIELO D GUERRA, BS

CONTACT

[email protected]

305-515-9887

LUANDA SIANO, PA

CONTACT

[email protected]

305-822-7227

Sponsors and collaborators

Lead sponsor

Urological Research Network, LLC

Other

Registry information

Official study title

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

Acronym: MRFLA

Important dates

Study start
2020
Primary completion
2025
Study completion
2038
First posted
Feb 15, 2022
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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