MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

NCT05241236 | Recruiting DMC FDA Device

• 1 other identifier: URN-20-014
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neoplasms Prostate; Cancer of the Prostate

Keywords

Prostate; PSA; FUSION; Ultrasound; MRI; Cancer; Laser; Outcomes; Recurrence; QOL, Quality of Life; Urinary function; Sexual Function

Outcome Measures

Primary Outcomes (1)

• Primary Oncological Control

  Negative CANCER Rate in treated area after fusion biopsy

  1 Year

Secondary Outcomes (4)

• Perioperative Outcomes

  90 days

• Urinary Function

  5 years

• Sexual Function

  5 years

• Radiological Cancer Control

  5 Years

Other Outcomes (2)

• Rate of Conversion to Whole gland treatment - Salvage Treatment

  10 years

• Rate of development of metastasis

  10 years

Interventions

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

Also known as: Intervention of Interest: Prostate Cancer Laser Ablation

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As written in Initial Section

You may qualify if:

• 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

You may not qualify if:

• Prior treatment of prostate cancer in the form of surgery.
• Performance status greater than 0 based on ECOG criteria
• Mental status impairment

Sponsors & Collaborators

• Urological Research Network, LLC: lead

Study Sites (1)

Urological Research Network

Miami Lakes, Florida, 33016, United States

RECRUITING

Related Publications (18)

• Moore CM, Kasivisvanathan V, Eggener S, Emberton M, Futterer JJ, Gill IS, Grubb Iii RL, Hadaschik B, Klotz L, Margolis DJ, Marks LS, Melamed J, Oto A, Palmer SL, Pinto P, Puech P, Punwani S, Rosenkrantz AB, Schoots IG, Simon R, Taneja SS, Turkbey B, Ukimura O, van der Meulen J, Villers A, Watanabe Y; START Consortium. Standards of reporting for MRI-targeted biopsy studies (START) of the prostate: recommendations from an International Working Group. Eur Urol. 2013 Oct;64(4):544-52. doi: 10.1016/j.eururo.2013.03.030. Epub 2013 Mar 20.

  PMID: 23537686 BACKGROUND

• Costa DN, Pedrosa I, Donato F Jr, Roehrborn CG, Rofsky NM. MR Imaging-Transrectal US Fusion for Targeted Prostate Biopsies: Implications for Diagnosis and Clinical Management. Radiographics. 2015 May-Jun;35(3):696-708. doi: 10.1148/rg.2015140058. Epub 2015 Mar 18.

  PMID: 25786055 BACKGROUND

• Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10.

  PMID: 22322308 BACKGROUND

• Eldred-Evans D, Neves JB, Simmons LAM, Kanthabalan A, McCartan N, Shah TT, Arya M, Charman SC, Freeman A, Moore CM, Punwani S, Emberton M, Ahmed HU. Added value of diffusion-weighted images and dynamic contrast enhancement in multiparametric magnetic resonance imaging for the detection of clinically significant prostate cancer in the PICTURE trial. BJU Int. 2020 Mar;125(3):391-398. doi: 10.1111/bju.14953. Epub 2019 Dec 11.

  PMID: 31733173 BACKGROUND

• Simmons LAM, Kanthabalan A, Arya M, Briggs T, Barratt D, Charman SC, Freeman A, Hawkes D, Hu Y, Jameson C, McCartan N, Moore CM, Punwani S, van der Muelen J, Emberton M, Ahmed HU. Accuracy of Transperineal Targeted Prostate Biopsies, Visual Estimation and Image Fusion in Men Needing Repeat Biopsy in the PICTURE Trial. J Urol. 2018 Dec;200(6):1227-1234. doi: 10.1016/j.juro.2018.07.001. Epub 2018 Jul 11.

  PMID: 30017964 BACKGROUND

• Hamid S, Donaldson IA, Hu Y, Rodell R, Villarini B, Bonmati E, Tranter P, Punwani S, Sidhu HS, Willis S, van der Meulen J, Hawkes D, McCartan N, Potyka I, Williams NR, Brew-Graves C, Freeman A, Moore CM, Barratt D, Emberton M, Ahmed HU. The SmartTarget Biopsy Trial: A Prospective, Within-person Randomised, Blinded Trial Comparing the Accuracy of Visual-registration and Magnetic Resonance Imaging/Ultrasound Image-fusion Targeted Biopsies for Prostate Cancer Risk Stratification. Eur Urol. 2019 May;75(5):733-740. doi: 10.1016/j.eururo.2018.08.007. Epub 2018 Dec 6.

  PMID: 30527787 BACKGROUND

• Bonmati E, Hu Y, Villarini B, Rodell R, Martin P, Han L, Donaldson I, Ahmed HU, Moore CM, Emberton M, Barratt DC. Technical Note: Error metrics for estimating the accuracy of needle/instrument placement during transperineal magnetic resonance/ultrasound-guided prostate interventions. Med Phys. 2018 Apr;45(4):1408-1414. doi: 10.1002/mp.12814. Epub 2018 Mar 9.

  PMID: 29443386 BACKGROUND

• Orczyk C, Barratt D, Brew-Graves C, Peng Hu Y, Freeman A, McCartan N, Potyka I, Ramachandran N, Rodell R, Williams NR, Emberton M, Ahmed HU. Prostate Radiofrequency Focal Ablation (ProRAFT) Trial: A Prospective Development Study Evaluating a Bipolar Radiofrequency Device to Treat Prostate Cancer. J Urol. 2021 Apr;205(4):1090-1099. doi: 10.1097/JU.0000000000001567. Epub 2020 Dec 14.

  PMID: 33315505 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

• Linares-Espinos E, Carneiro A, Martinez-Salamanca JI, Bianco F, Castro-Alfaro A, Cathelineau X, Valerio M, Sanchez-Salas R. New technologies and techniques for prostate cancer focal therapy. Minerva Urol Nefrol. 2018 Jun;70(3):252-263. doi: 10.23736/S0393-2249.18.03094-1. Epub 2018 Apr 16.

  PMID: 29664243 BACKGROUND

• Gross MD, Sedrakyan A, Bianco FJ, Carroll PR, Daskivich TJ, Eggener SE, Ehdaie B, Fisher B, Gorin MA, Hunt B, Jiang H, Klein EA, Marinac-Dabic D, Montgomery JS, Polascik TJ, Priester AM, Rastinehad AR, Viviano CJ, Wysock JS, Hu JC. SPARED Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer. J Urol. 2019 Nov;202(5):952-958. doi: 10.1097/JU.0000000000000357. Epub 2019 Oct 9.

  PMID: 31144591 BACKGROUND

• Reis LO, Andrade DL, Bianco FJ Jr. Super active surveillance for low-risk prostate cancer | Opinion: Yes. Int Braz J Urol. 2019 Mar-Apr;45(2):210-214. doi: 10.1590/S1677-5538.IBJU.2019.02.02. No abstract available.

  PMID: 31021584 BACKGROUND

• Ahdoot M, Lebastchi AH, Turkbey B, Wood B, Pinto PA. Contemporary treatments in prostate cancer focal therapy. Curr Opin Oncol. 2019 May;31(3):200-206. doi: 10.1097/CCO.0000000000000515.

  PMID: 30865133 BACKGROUND

• Lodeizen O, de Bruin M, Eggener S, Crouzet S, Ghai S, Varkarakis I, Katz A, Dominguez-Escrig JL, Pahernik S, de Reijke T, de la Rosette J. Ablation energies for focal treatment of prostate cancer. World J Urol. 2019 Mar;37(3):409-418. doi: 10.1007/s00345-018-2364-x. Epub 2018 Jun 25.

  PMID: 29943219 BACKGROUND

• Lindner U, Lawrentschuk N, Trachtenberg J. Focal laser ablation for localized prostate cancer. J Endourol. 2010 May;24(5):791-7. doi: 10.1089/end.2009.0440.

  PMID: 20477544 BACKGROUND

• Chao B, Llukani E, Lepor H. Two-year Outcomes Following Focal Laser Ablation of Localized Prostate Cancer. Eur Urol Oncol. 2018 Jun;1(2):129-133. doi: 10.1016/j.euo.2018.03.011. Epub 2018 May 15.

  PMID: 31100236 BACKGROUND

• Oto A, Sethi I, Karczmar G, McNichols R, Ivancevic MK, Stadler WM, Watson S, Eggener S. MR imaging-guided focal laser ablation for prostate cancer: phase I trial. Radiology. 2013 Jun;267(3):932-40. doi: 10.1148/radiol.13121652. Epub 2013 Feb 25.

  PMID: 23440319 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• FERNANDO J BIANCO, MD

  UROLOGICAL RESEARCH NETWORK

  PRINCIPAL INVESTIGATOR

• EUSEBIO LUNA, MD

  UROLOGICAL RESEARCH NETWORK

  STUDY DIRECTOR

• Isabel H Lopez, MD

  UROLOGICAL RESEARCH NETWORK

  STUDY DIRECTOR

Central Study Contacts

CIELO D GUERRA, BS

CONTACT

305-515-9887; CIELO@BESTUROLOGY.NET

LUANDA SIANO, PA

CONTACT

305-822-7227; LUANDA@BESTUROLOGY.NET

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: February 15, 2022
• Study Start: November 15, 2020
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2038
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 years
• Access Criteria: institutional agreement, HIPPA compliance

Locations

US (1)