TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer

NCT05698576 | Recruiting DMC

• 2 other identifiers: URN-2022-002Pro00060491
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is set up as a phase I prospective, single center, device interventional pilot study carried in office setting under local anesthesia. It will assess the tolerance and safety of target fusion ablation of prostate cancer tumors using Laser Induced Thermal Therapy (TFA-LITT) guided by fusion imaging in men 50 to 80 years of age with low to intermediate risk prostate cancer Prostate Cancer is currently managed with in a discrete fashion where patients either enroll in active surveillance protocols (No intervention) or undergo full intervention via whole gland treatments - most commonly radical surgery or radiation. These treatments have not shown definitive gains in all cause survival and not uncommonly harbor undesirable adverse effects, most notably: impotency and incontinence. Such events elicit significant and noticeable changes on a male lifestyle and for most prostate cancer tumors are considered overtreatment. This study aims to evaluate the use of TFA-LITT in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk - focused on the organ sparing cancer lesion ablation, where organ function is preserved. The fundamental objective is to determine the tolerance and safety of TFA-LITT in men with low to intermediate risk prostate cancer, successful performed in the outpatient office-based setting under local anesthesia directed by fusion imaging. Secondary objectives include: 1-Biopsy proven cancer control of ablated areas 12 months after procedure; 2-Uroflowmetry and urinary function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 3- Sexual function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 4- MRI changes of ablated area one, three and 12 months after TFA-LITT; 5- Absence or presence of ejaculation after TFA-LITT.

Conditions

Prostate Cancer; Adverse Effects Surgery; MRI; Ultrasound; Sexual Function Disturbances; Urinary Incontinence; Urinary Function Disorders; Prostate Biopsy; Ablation

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of TRANBERG® TPF-LITT performed in the office setting under local anesthesia.

  Tolerability will be assessed during the execution of TFP-LITT at several phases of the treatment. An analog pain scale will be provided to the patient, whom will be asked to describe any pain scores at each of the following treatment successions: 1. superficial perineal block, 2. foley advancement, 3. deep perineal block, 4. fusion co-registration, 5. before and after each ablation, 6-Once the patient has recovered, he will be asked for an overall pain assessment. Safety will be evaluated by assessments of the 7-day, 30-day and 90-day AEs reported using the CTCAE scale, as perioperative assessments will be conducted at each of these milestones. A grade 3 or worse AEs based on the CTCAE v5.0 within 90 days post procedure will be considered severe. Any registered AEs will be labelled as follows: 1. Not related 2. Possible 3. Probable 4. Causal relationship

  90 days

Secondary Outcomes (10)

• Average Ablated area volume (in cc) measured by MRI immediately following the procedure

  24-72 hours after procedure

• Average Ablated area volume (in cc) measured by MRI 1-month following the procedure

  30 days

• Average Ablated area volume (in cc) measured by MRI 3-month following the procedure

  90 days

• Average Ablated area volume (in cc) measured by MRI 1-year following the procedure

  1 year

• Number of patients with a 75% decrease in Serum PSA levels (ng/ml) after procedure measured at fixed intervals

  1 year

Study Arms (1)

TPF-LITT ARM

EXPERIMENTAL

partial gland ablation of the prostate using laser device and imaging fusion

Device: TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT)

Interventions

TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) DEVICE

A perineal local anesthesia block is performed with patient on lithotomy. The ultrasound probe is advanced, secured to digital stepper. The live ultrasound image feed is visible on the FOCALYX® Fusion device. Image co-registration (MR/US) will be performed. The FOCALYX® Fusion device shows outline of the prostate on the MRI and the target area(s) in real-time. The urologist advances laser fiber introducer, temperature probes to indicated coordinates. Target treatment - applying TRANBERG® laser energy over the treatment area and controlling delivery with a pedal. Treatment is monitored using FOCALYX® Fusion device in real-time. One laser fiber will be used and a single or multiple applications may be required. The fiber will be relocated to other targets if present. Patient will be dismissed to the MRI center where a multiparametric MRI will be conducted. After this study is completed, the patient will be discharged home with instructions and contact information.

Also known as: Fusion Imaging Laser induced thermal therapy for prostate partial gland ablation.

TPF-LITT ARM

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to sign informed consent
• Subject is able and willing to complete all procedure and follow-up visits indicated in the protocol
• Absence of urinary retention
• Prostate volume: ≥ 18 and ≤ 100 cc, measured by transrectal ultrasound
• Serum creatinine levels \<2 ng/dl and GFR \> 45
• Serum PSA levels \< 20 ng/ml
• Multiparametric prostate MRI with piRADS scores 3-5
• Prostate volume: ≥ 18 and ≤ 100 cc, measured by MRI
• Presence of Intermediate risk prostate cancer with a volume that is less than 1/3 of the gland volume by MRI evaluation

You may not qualify if:

• Post-void residual (PVR): \> 250 mL or \> 50% of voided volume
• Previous prostate cancer intervention (Radiation therapy, brachytherapy, prostate cryoablation
• Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
• Evidence of neurogenic bladder determined by urodynamics studies
• Presence of Indwelling Foley catheter or on active regime of clean intermittent catheterization (CIC) in the prior 30 days
• Active urinary tract infection determined by urinary cultures
• SHIM score \<14
• IPSS score \>23
• Acute prostatitis
• Macroscopic hematuria without a known contributing factor
• History of colorectal carcinoma with anterior perineal resection of rectum
• History of pelvic radiation therapy or radical pelvic surgery
• History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date
• Bladder stones
• Medical contraindication for undergoing TPFLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery)

Sponsors & Collaborators

• Urological Research Network, LLC: lead

Study Sites (1)

Urology Specialist Group

Hialeah, Florida, 33016, United States

RECRUITING

Related Publications (12)

• Carter G, Clover K, Britton B, Mitchell AJ, White M, McLeod N, Denham J, Lambert SD. Wellbeing during Active Surveillance for localised prostate cancer: a systematic review of psychological morbidity and quality of life. Cancer Treat Rev. 2015 Jan;41(1):46-60. doi: 10.1016/j.ctrv.2014.11.001. Epub 2014 Nov 13.

  PMID: 25467109 BACKGROUND

• Cooperberg MR, Carroll PR, Klotz L. Active surveillance for prostate cancer: progress and promise. J Clin Oncol. 2011 Sep 20;29(27):3669-76. doi: 10.1200/JCO.2011.34.9738. Epub 2011 Aug 8.

  PMID: 21825257 BACKGROUND

• Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.

  PMID: 27626136 BACKGROUND

• Loeb S, Carter HB, Schwartz M, Fagerlin A, Braithwaite RS, Lepor H. Heterogeneity in active surveillance protocols worldwide. Rev Urol. 2014;16(4):202-3. No abstract available.

  PMID: 25548550 BACKGROUND

• Cooley LF, Emeka AA, Meyers TJ, Cooper PR, Lin DW, Finelli A, Eastham JA, Logothetis CJ, Marks LS, Vesprini D, Goldenberg SL, Higano CS, Pavlovich CP, Chan JM, Morgan TM, Klein EA, Barocas DA, Loeb S, Helfand BT, Scholtens DM, Witte JS, Catalona WJ; Collaborators. Factors Associated with Time to Conversion from Active Surveillance to Treatment for Prostate Cancer in a Multi-Institutional Cohort. J Urol. 2021 Nov;206(5):1147-1156. doi: 10.1097/JU.0000000000001937. Epub 2021 Sep 10.

  PMID: 34503355 BACKGROUND

• Al-Hakeem Y, Raz O, Gacs Z, Maclean F, Varol C. Magnetic resonance image-guided focal laser ablation in clinically localized prostate cancer: safety and efficacy. ANZ J Surg. 2019 Dec;89(12):1610-1614. doi: 10.1111/ans.15526. Epub 2019 Nov 3.

  PMID: 31679182 BACKGROUND

• Lee T, Mendhiratta N, Sperling D, Lepor H. Focal laser ablation for localized prostate cancer: principles, clinical trials, and our initial experience. Rev Urol. 2014;16(2):55-66.

  PMID: 25009445 BACKGROUND

• Walser E, Nance A, Ynalvez L, Yong S, Aoughsten JS, Eyzaguirre EJ, Williams SB. Focal Laser Ablation of Prostate Cancer: Results in 120 Patients with Low- to Intermediate-Risk Disease. J Vasc Interv Radiol. 2019 Mar;30(3):401-409.e2. doi: 10.1016/j.jvir.2018.09.016.

  PMID: 30819483 BACKGROUND

• Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.

  PMID: 29552975 BACKGROUND

• Simmons LAM, Kanthabalan A, Arya M, Briggs T, Barratt D, Charman SC, Freeman A, Gelister J, Hawkes D, Hu Y, Jameson C, McCartan N, Moore CM, Punwani S, Ramachandran N, van der Meulen J, Emberton M, Ahmed HU. The PICTURE study: diagnostic accuracy of multiparametric MRI in men requiring a repeat prostate biopsy. Br J Cancer. 2017 Apr 25;116(9):1159-1165. doi: 10.1038/bjc.2017.57. Epub 2017 Mar 28.

  PMID: 28350785 BACKGROUND

• Bianco FJ, Martinez-Salamanca JI. Focalyx Dx, Bx, Tx et Apps: A novel contemporary fusion paradigm for the management of prostate cancer. Arch Esp Urol. 2016 Jul;69(6):353-63.

  PMID: 27416639 BACKGROUND

• Hu Y, van den Boom R, Carter T, Taylor Z, Hawkes D, Ahmed HU, Emberton M, Allen C, Barratt D. A comparison of the accuracy of statistical models of prostate motion trained using data from biomechanical simulations. Prog Biophys Mol Biol. 2010 Dec;103(2-3):262-72. doi: 10.1016/j.pbiomolbio.2010.09.009. Epub 2010 Sep 30.

  PMID: 20869389 BACKGROUND

Related Links

• MRI/US FUSION GUIDED PROSTATE BIOPSY AND CRYOTHERAPY IN A CLINICAL OFFICE SETTING Fernando Bianco, Eusebio Luna, Luanda Perez, Lopez-Prieto, Edward Gheiler, Ariel Kaufman, Shafizadeh, Zachareas, Martinez-Salamanca, Egui

MeSH Terms

Conditions

Prostatic Neoplasms; Sexual Dysfunctions, Psychological; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando J Bianco, MD

  Urological Research Network

  PRINCIPAL INVESTIGATOR

• Isabel H Lopez, BS., MBA

  Urological Research Network

  STUDY DIRECTOR

Central Study Contacts

Cielo D Guerra, BS

CONTACT

786-431-2014; cielo@besturology.net

Luanda Perez, PA.C

CONTACT

305-822-7227; luanda@besturology.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Voluntary participation in a Prospective controlled cohort

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 26, 2023
• Study Start: March 16, 2022
• Primary Completion: January 27, 2023
• Study Completion (Estimated): January 30, 2033
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 3 years
• Access Criteria: formal request, institutional agreements

Locations

US (1)