MRI-guided Focused Ultrasound Ablation for Localized Intermediate-Risk Prostate Cancer: Early Results of a Phase II Trial.


Journal

Radiology
ISSN: 1527-1315
Titre abrégé: Radiology
Pays: United States
ID NLM: 0401260

Informations de publication

Date de publication:
03 2021
Historique:
pubmed: 3 2 2021
medline: 12 10 2021
entrez: 2 2 2021
Statut: ppublish

Résumé

Background To reduce adverse effects of whole-gland therapy, participants with localized clinically significant prostate cancer can undergo MRI-guided focal therapy. Purpose To explore safety and early oncologic and functional outcomes of targeted focal high-intensity focused ultrasound performed under MRI-guided focused ultrasound for intermediate-risk clinically significant prostate cancer. Materials and Methods In this prospective phase II trial, between February 2016 and July 2019, men with unifocal clinically significant prostate cancer visible at MRI were treated with transrectal MRI-guided focused ultrasound. The primary end point was the 5-month biopsy (last recorded in December 2019) with continuation to the 24-month follow-up projected to December 2021. Real-time ablation monitoring was performed with MR thermography. Nonperfused volume was measured at treatment completion. Periprocedural complications were recorded. Follow-up included International Prostate Symptom Score (IPSS) and International Index of Erectile Function-15 (IIEF-15) score at 6 weeks and 5 months, and multiparametric MRI and targeted biopsy of the treated area at 5 months. The generalized estimating equation model was used for statistical analysis, and the Holm method was used to adjust

Identifiants

pubmed: 33529137
doi: 10.1148/radiol.2021202717
doi:

Types de publication

Clinical Trial, Phase II Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

695-703

Commentaires et corrections

Type : CommentIn
Type : ErratumIn
Type : CommentIn

Auteurs

Sangeet Ghai (S)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Antonio Finelli (A)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Kateri Corr (K)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Rosanna Chan (R)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Sarah Jokhu (S)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Xuan Li (X)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Stuart McCluskey (S)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Anna Konukhova (A)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Eugen Hlasny (E)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Theodorus H van der Kwast (TH)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Peter F Incze (PF)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Alexandre R Zlotta (AR)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Robert J Hamilton (RJ)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Masoom A Haider (MA)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Walter Kucharczyk (W)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

Nathan Perlis (N)

From the Joint Department of Medical Imaging (S.G., R.C., E.H., M.A.H., W.K.), Division of Urology, Department of Surgical Oncology (A.F., K.C., S.J., A.K., A.R.Z., R.J.H., N.P.), Biostatistics Department, Princess Margaret Cancer Centre (X.L.), Department of Anaesthesia (S.M.), and Department of Pathology, Laboratory Medicine Program (T.H.v.d.K.), University Health Network-Mount Sinai Hospital-Women's, College Hospital, University of Toronto, 585 University Ave, Toronto, ON, Canada M5G 2N2; and Department of Urology, Oakville Trafalgar Memorial Hospital, Toronto, Canada (P.F.I.).

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