Ablación Láser Focal Guiada por Micro-ultrasonidos para el Cáncer de Próstata de Riesgo Intermedio: Seguridad y Eficacia (MicroUSgFLA)
Tratamiento con Ablación Láser Focal Guiada por Micro-ultrasonido (MicroUSgFLA) para el Manejo del Cáncer de Próstata de Riesgo Intermedio: Evaluación de Seguridad y Eficacia
This clinical research study is intended to show that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe procedure that can significantly postpone or eliminate the need for patients with intermediate-Risk prostate cancer (PCa) to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation Therapy) for their disease.
Descripción general del estudio
Estado
Descripción detallada
Prostate cancer is the most common cancer in men, and a large proportion of these diagnoses are of the low or intermediate risk type that are amenable to a minimally invasive approach to treatment such as Focal Therapy. If successful, this study will show that trans-perineal interstitial laser focal therapy of the prostate could be offered over a wider community setting than only at a major hospital as an Magnetic Resonance Imaging (MRI), to confidently locate the Index Lesion would not be required because MicroUS is showing the same potential to visualize the lesion. MicroUS-guided focal laser ablation would be a simpler treatment than the complexity required under MRI, it could be offered in communities that might not have local access to MRI facilities and could be offered to individuals who are contra-indicated for MRI for such reasons as having metallic implants or severe claustrophobia.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sangeet Ghai, MD
- Número de teléfono: 416-340-4656
- Correo electrónico: sangeet.ghai@uhn.ca
Copia de seguridad de contactos de estudio
- Nombre: Kateri Corr
- Número de teléfono: 5501 416-946-4501
- Correo electrónico: kateri.corr@uhn.ca
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 2M9
- Reclutamiento
- University Health Network - Princess Margaret Cancer Centre
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Sub-Investigador:
- Nathan Perlis, MD
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Contacto:
- Sangeet Ghai, MD
- Número de teléfono: 416-340-4656
- Correo electrónico: sangeet.ghai@uhn.ca
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Contacto:
- Kateri Corr
- Número de teléfono: 5501 416-946-4501
- Correo electrónico: kateri.corr@uhn.ca
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Investigador principal:
- Sangeet Ghai, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Men 40-80 years of age.
- Histologically-proven intermediate-risk PCa (Gleason score 7, primary grade ≤ 4).
- PCa clinical stage T1c or T2.
- MRI/MicroUS site suspicious for cancer or cancer mapped to one prostate lobe.
- Maximum dimension of MRI/MicroUS visible tumour ≤15mm.
- Suspicious site on Prostate MRI/MicroUS must coincide with sector positive for cancer on biopsy.
- Prostate specific antigen (PSA) level < 15 ng/mL.
- IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure.
- Life expectancy of greater than 10 years, based on co-morbidity not related to PCa.
Exclusion Criteria:
- Maximum dimension of MRI/MicroUS visible tumour > 15 mm.
- Patients medically unfit for focal therapy of the prostate.
- Patients who are unwilling or unable to give informed consent.
- Patients who have received androgen suppression therapy.
- Patients who have received or are receiving chemotherapy for prostate carcinoma.
- Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive) including HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment.
- Patients who have undergone radiation therapy for PCa or to the pelvis.
- Any condition or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies).
- Patients with a history of non-compliance with medical therapy and/or medical recommendations.
- Patients who are unwilling or unable to complete the patient self-assessment questionnaires.
- Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
- Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days.
- Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Single-Arm Prospective Clinical Trial
This is a single arm study where patients with intermediate risk MR visible locally confined prostate cancer will be treated with Micro-Ultrasound Guided Focal Laser Ablation. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months with PSA. |
x
Otros nombres:
Micro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS|Thermal Therapy
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Primary Outcome 1:
Periodo de tiempo: From enrollment to the end of treatment at 6 months.
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Number of Participants With Procedure-Related Adverse Events Time Frame: Up to 6 months after procedure Outcome Type: Safety Measure Description: Number and severity of procedure-related adverse events (AEs), graded according to CTCAE v5.0, to evaluate the safety profile of focal Micro-Ultrasound-Guided Focal Laser Ablation (MicroUS-gFLA) in patients with organ-confined intermediate-risk prostate cancer. Unit of Measure: Number of participants |
From enrollment to the end of treatment at 6 months.
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Primary Outcome 2: Technical Success Rate of MicroUS-gFLA
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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Primary Outcome 2: Technical Success Rate of MicroUS-gFLA Time Frame: At completion of procedure; confirmed during follow-up up to 6 months Outcome Type: Feasibility Measure Description: Proportion of procedures achieving technical success, defined as: successful visualization and MicroUS-guided trocar insertion into the target lesion, and completion of focal laser ablation exactly as planned, as confirmed by intra-procedural imaging and follow-up mpMRI and/or biopsy. Unit of Measure: Percentage of procedures |
From enrollment to the end of treatment at 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Secondary Outcome 1 - Change in PSA Level From Baseline
Periodo de tiempo: From enrollment to the end of treatment at 6 months.
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Secondary Outcome 1 - Change in PSA Level From Baseline Time Frame: Baseline to 6 months Outcome Type: Efficacy Measure Description: Change in serum prostate-specific antigen (PSA) level from baseline prior to ablation to 6-month follow-up. Unit of Measure: Change in PSA (ng/mL) |
From enrollment to the end of treatment at 6 months.
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Secondary Outcome 2: Change in Urinary Function (IPSS Score)
Periodo de tiempo: From enrollment to the end of the treatment at 6 months
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Secondary Outcome 2: Change in Urinary Function (IPSS Score) Time Frame: Baseline, 3 months, and 6 months Outcome Type: Functional Measure Description: Change in urinary function measured using the International Prostate Symptom Score (IPSS). Unit of Measure: Change in score (IPSS scale) |
From enrollment to the end of the treatment at 6 months
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Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score)
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score) Time Frame: Baseline, 3 months, and 6 months Outcome Type: Functional Measure Description: Change in erectile function measured using the International Index of Erectile Function-15 (IIEF-15) questionnaire. Unit of Measure: Change in score (IIEF-15 scale) |
From enrollment to the end of treatment at 6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sangeet Ghai, MD, The Princess Margaret Cancer Foundation
Publicaciones y enlaces útiles
Publicaciones Generales
- Lindner U, Weersink RA, Haider MA, Gertner MR, Davidson SR, Atri M, Wilson BC, Fenster A, Trachtenberg J. Image guided photothermal focal therapy for localized prostate cancer: phase I trial. J Urol. 2009 Oct;182(4):1371-7. doi: 10.1016/j.juro.2009.06.035. Epub 2009 Aug 14.
- Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1.
- Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, Lieber MM, Cespedes RD, Atkins JN, Lippman SM, Carlin SM, Ryan A, Szczepanek CM, Crowley JJ, Coltman CA Jr. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003 Jul 17;349(3):215-24. doi: 10.1056/NEJMoa030660. Epub 2003 Jun 24.
- Potosky AL, Davis WW, Hoffman RM, Stanford JL, Stephenson RA, Penson DF, Harlan LC. Five-year outcomes after prostatectomy or radiotherapy for prostate cancer: the prostate cancer outcomes study. J Natl Cancer Inst. 2004 Sep 15;96(18):1358-67. doi: 10.1093/jnci/djh259.
- Ghai S, Eure G, Fradet V, Hyndman ME, McGrath T, Wodlinger B, Pavlovich CP. Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J Urol. 2016 Aug;196(2):562-9. doi: 10.1016/j.juro.2015.12.093. Epub 2016 Jan 12.
- Guillaumier S, Peters M, Arya M, Afzal N, Charman S, Dudderidge T, Hosking-Jervis F, Hindley RG, Lewi H, McCartan N, Moore CM, Nigam R, Ogden C, Persad R, Shah K, van der Meulen J, Virdi J, Winkler M, Emberton M, Ahmed HU. A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer. Eur Urol. 2018 Oct;74(4):422-429. doi: 10.1016/j.eururo.2018.06.006. Epub 2018 Jun 28.
- Thompson IM, Pauler DK, Goodman PJ, Tangen CM, Lucia MS, Parnes HL, Minasian LM, Ford LG, Lippman SM, Crawford ED, Crowley JJ, Coltman CA Jr. Prevalence of prostate cancer among men with a prostate-specific antigen level < or =4.0 ng per milliliter. N Engl J Med. 2004 May 27;350(22):2239-46. doi: 10.1056/NEJMoa031918.
- Lindner U, Lawrentschuk N, Weersink RA, Davidson SR, Raz O, Hlasny E, Langer DL, Gertner MR, Van der Kwast T, Haider MA, Trachtenberg J. Focal laser ablation for prostate cancer followed by radical prostatectomy: validation of focal therapy and imaging accuracy. Eur Urol. 2010 Jun;57(6):1111-4. doi: 10.1016/j.eururo.2010.03.008. Epub 2010 Mar 12.
- Peters RD, Chan E, Trachtenberg J, Jothy S, Kapusta L, Kucharczyk W, Henkelman RM. Magnetic resonance thermometry for predicting thermal damage: an application of interstitial laser coagulation in an in vivo canine prostate model. Magn Reson Med. 2000 Dec;44(6):873-83. doi: 10.1002/1522-2594(200012)44:63.0.co;2-x.
- Alibhai SM, Naglie G, Nam R, Trachtenberg J, Krahn MD. Do older men benefit from curative therapy of localized prostate cancer? J Clin Oncol. 2003 Sep 1;21(17):3318-27. doi: 10.1200/JCO.2003.09.034.
- Reddy D, Bedi N, Dudderidge T. Focal therapy, time to join the multi-disciplinary team discussion? Transl Androl Urol. 2020 Jun;9(3):1526-1534. doi: 10.21037/tau.2019.09.30.
- Langer DL, van der Kwast TH, Evans AJ, Sun L, Yaffe MJ, Trachtenberg J, Haider MA. Intermixed normal tissue within prostate cancer: effect on MR imaging measurements of apparent diffusion coefficient and T2--sparse versus dense cancers. Radiology. 2008 Dec;249(3):900-8. doi: 10.1148/radiol.2493080236.
- Eure G, Fanney D, Lin J, Wodlinger B, Ghai S. Comparison of conventional transrectal ultrasound, magnetic resonance imaging, and micro-ultrasound for visualizing prostate cancer in an active surveillance population: A feasibility study. Can Urol Assoc J. 2019 Mar;13(3):E70-E77. doi: 10.5489/cuaj.5361. Epub 2018 Aug 30.
- Johansson JE, Andren O, Andersson SO, Dickman PW, Holmberg L, Magnuson A, Adami HO. Natural history of early, localized prostate cancer. JAMA. 2004 Jun 9;291(22):2713-9. doi: 10.1001/jama.291.22.2713.
- McLeod DG, Iversen P, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Bicalutamide 150 mg plus standard care vs standard care alone for early prostate cancer. BJU Int. 2006 Feb;97(2):247-54. doi: 10.1111/j.1464-410X.2005.06051.x.
- Ramirez AG, Trapido EJ. Advancing the Science of Cancer in Latinos. 2022 Nov 15. In: Ramirez AG, Trapido EJ, editors. Advancing the Science of Cancer in Latinos: Building Collaboration for Action [Internet]. Cham (CH): Springer; 2023. Chapter 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK595808/
- Wenger H, Yousuf A, Oto A, Eggener S. Laser ablation as focal therapy for prostate cancer. Curr Opin Urol. 2014 May;24(3):236-40. doi: 10.1097/MOU.0000000000000044.
- Klotz L, Lughezzani G, Maffei D, Sanchez A, Pereira JG, Staerman F, Cash H, Luger F, Lopez L, Sanchez-Salas R, Abouassaly R, Shore ND, Eure G, Paciotti M, Astobieta A, Wiemer L, Hofbauer S, Heckmann R, Gusenleitner A, Kaar J, Mayr C, Loidl W, Rouffilange J, Gaston R, Cathelineau X, Klein E. Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: A multicenter, prospective analysis. Can Urol Assoc J. 2021 Jan;15(1):E11-E16. doi: 10.5489/cuaj.6712.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias Genitales Masculinas
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades Genitales Masculinas
- Enfermedades prostáticas
- Enfermedades urogenitales masculinas
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Carcinoma
- Neoplasias prostáticas
- Adenocarcinoma
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Estudios epidemiológicos
- Características del estudio epidemiológico
- Estudios de cohorte
- Estudios longitudinales
Otros números de identificación del estudio
- 21-6189
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified individual participant data that relate to the results reported in the primary publication (e.g., baseline demographics, imaging findings, treatment parameters, outcomes, and adverse events).
Marco de tiempo para compartir IPD
Beginning 6 months after publication of the primary results for up to 5 years thereafter.
Criterios de acceso compartido de IPD
Data will be available to investigators with methodologically sound research proposals for use in projects related to prostate imaging, focal therapy, or outcomes research. All requestors will be required to sign a data use agreement to ensure participant confidentiality.
Data requests should be submitted to the study principal investigator. Approved proposals will be granted access via a secure institutional data-sharing platform.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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