MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

Cancer of the Prostate Clinical Trial

— MRFLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05241236
• Other study ID #: URN-20-014
• Status: Recruiting
• Start date: November 15, 2020
• Est. completion date: November 2038

Study information

• Verified date: January 2023
• Source: Urological Research Network, LLC
• Contact: CIELO D GUERRA, BS
• Phone: 305-515-9887
• Email: CIELO[@]BESTUROLOGY.NET
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: November 2038
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Prostate
• Neoplasms Prostate
• Prostatic Neoplasms

Intervention

Device:
• Image Fusion (MR/US) Software Registration Guided Laser Ablation of Prostate Cancer
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

Locations

Country	Name	City	State
United States	Urological Research Network	Miami Lakes	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Urological Research Network, LLC

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Conversion to Whole gland treatment - Salvage Treatment	Conversion to radical surgery or radiation or cryoablation	10 years
Other	Rate of development of metastasis	Detection of metastatic disease	10 years
Primary	Primary Oncological Control	Negative CANCER Rate in treated area after fusion biopsy	1 Year
Secondary	Perioperative Outcomes	Rate of Adverse Events and Serious Adverse Events following CTCAE v5 classification	90 days
Secondary	Urinary Function	Rate of AUA symptoms score less than 7 (Scale 0-35).	5 years
Secondary	Sexual Function	Rate of Sexual Inventory for men scores above 15 (Scale 1-25)	5 years
Secondary	Radiological Cancer Control	Rate of Detection of discrete lesions following multi-parametric prostate MRI	5 Years