Focal Laser Ablation of Prostate Cancer Tumors

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliKuajiri

Wadhamini

Mayo Clinic

JARIBIO LA KLINIKI: NCT02600156

BioSeek: nct02600156

Maneno muhimu

saratani

Kikemikali

The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.

Maelezo

The study is being done to evaluate the safety and effectiveness of Magnetic Resonance Imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low-risk prostate cancer tumors. Unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy.

Tarehe

Imethibitishwa Mwisho:	04/30/2020
Iliyowasilishwa Kwanza:	09/03/2015
Uandikishaji uliokadiriwa Uliwasilishwa:	11/04/2015
Iliyotumwa Kwanza:	11/08/2015
Sasisho la Mwisho Liliwasilishwa:	05/25/2020
Sasisho la Mwisho Lilichapishwa:	05/26/2020
Tarehe halisi ya kuanza kwa masomo:	08/31/2015
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	11/30/2020
Tarehe ya Kukamilisha Utafiti:	11/30/2022

Hali au ugonjwa

Prostate Cancer

Uingiliaji / matibabu

Procedure: Single arm study

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: Single arm study MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.	Procedure: Single arm study MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	45 Years Kwa 45 Years
Jinsia Inastahiki Kujifunza	Male
Hupokea Wajitolea wa Afya	Ndio
Vigezo	Inclusion Criteria - Male, 45 years of age or older. - Diagnosis of prostate adenocarcinoma. - Clinical stage T1c or T2a. - Gleason score of 7 (3+4 or 4+3) or Intermediate risk Gleason 6 - PSA less than or equal to 20 ng/mL - Three or fewer biopsy locations with prostate cancer which correlate with MRI findings. - No lesion > or = 2cm - One, two, or three tumor suspicious regions identified on multiparametric MRI - No definite radiographic indication of extra-capsular extension. - Estimated survival of 5 years or greater, as determined by treating physician. - Tolerance for anesthesia/sedation. - Ability to give informed consent. Exclusion Criteria - Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI. - History of other primary non-skin malignancy within previous three years.

Matokeo

Hatua za Matokeo ya Msingi

1. Success rate [3 years]

To evaluate the procedural success rate of using the MR-guided laser ablation to target, access, thermally monitor, and focally ablate MR-visible prostate cancer lesions.

2. Incidence of treatment emergent adverse events [3 years]

To evaluate patient-related safety by monitoring short and long-term complications related to the procedure such as but not limited to incontinence, impotence, and urethral fistulas.

Hatua za Matokeo ya Sekondari

1. Short- and mid-term ablative success [3 years]

To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas.