MRI Guided Prostate Cancer Focal Laser Ablation
Raktažodžiai
Santrauka
apibūdinimas
Prostate cancer should be viewed as a spectrum of diseases ranging from a very indolent low-risk process to an aggressive high-risk potentially fatal disease. Active surveillance has been introduced as an alternative treatment to patients with low- risk prostate cancers.Focal therapy techniques have been introduced in prostate cancer to destroy the tumor itself with adequate safety margin with the advantage of preserving the surrounding non-cancerous tissue. Thus maintaining disease control at acceptable levels, while minimizing complications.
With the advent of multiparametric MRI (Mp-MRI), it is now possible to identify suspicious prostate gland focal lesions, determining their extent and targeting them for biopsy and focal ablation. Laser interstitial thermal therapy (LITT) is well suited for MRI environment. Laser fibers are flexible so they can fit into the MRI gantry. Laser has been shown to produce homogenous tissue necrosis that can be monitored by real time temperature maps, a feature that facilitates effective and safe ablation.
20 subjects with localized low and intermediate risk prostate cancer that meet the inclusion and exclusion criteria will be enrolled. During baseline evaluation, subjects will undergo lab tests, MR imaging, and will complete QOL questionnaires. Subsequently, subjects will undergo the Magnetic Resonance Imaging (MRI) Guided Focal Laser Interstitial Thermal Ablation procedure. Subjects will be followed immediately after the procedure, at 3 weeks, 3 months, 6 months, one year and two years after procedure for adverse events and recurrence of prostate cancer
Datos
| Paskutinį kartą patikrinta: | 02/29/2020 |
| Pirmasis pateikimas: | 07/18/2018 |
| Numatytas registravimas pateiktas: | 08/14/2018 |
| Pirmas paskelbtas: | 08/15/2018 |
| Paskutinis atnaujinimas pateiktas: | 03/08/2020 |
| Paskutinis atnaujinimas paskelbtas: | 03/22/2020 |
| Pirmųjų rezultatų pateikimo data: | 03/08/2020 |
| Pirmojo QC rezultatų pateikimo data: | 03/08/2020 |
| Pirmųjų paskelbtų rezultatų data: | 03/22/2020 |
| Faktinė studijų pradžios data: | 05/31/2018 |
| Numatoma pirminio užbaigimo data: | 03/14/2019 |
| Numatoma studijų užbaigimo data: | 03/14/2019 |
Būklė ar liga
Intervencija / gydymas
Device: MRI-guided focal laser ablation
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: MRI-guided focal laser ablation Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer. | Device: MRI-guided focal laser ablation The procedure is done under general anesthesia. Laser fiber placement will be performed by one of two approaches (Trans gluteal or trans rectal) based on the target location within the prostate gland. When the needle position is deemed satisfactory, a 1.5-cm-active tip diode laser fiber will be introduced within an internally cooled catheter through the introducing sheath.
The catheter tip location will be confirmed on Turbo Spin-Echo (TSE) T2-weighted images in the axial and sagittal oblique planes.The introducer sheath will be withdrawn to allow contact of the active laser tip with the lesion. A laser test dose will be done at 9 Watts for about 30 seconds to confirm the site of fiber placement with the subsequent delivery of full dose ablation at 12-27 Watts. Ablation duration is determined based on real time feedback of response using real time temperature and damage estimate maps. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | Male |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - Age ≥18 years - Patients with primary organ confined prostate cancer (≤T2c) and Gleason score ≤4+3=7 - Lesions visible on multiparametric MRI and subsequently diagnosed by targeted MRI guided biopsy Exclusion Criteria: - Multifocal intra-prostatic disease, defined as the presence the presence of ≥ 3 non- contiguous pathologically proven foci of cancer. - Gleason score >4+3=7. - Extracapsular spread. - Nodal or distant metastasis - Contraindications to MRI or general anesthesia. - Uncorrectable Coagulopathy. - Refusal of participation. - Lesions not visualized on the multiparametric MRI |
Rezultatas
Pirminės rezultatų priemonės
1. Number of Recurrences of Prostate Cancer at the End of 1 Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation [Up to 12 months]
2. Percentage of Grade 3 or Higher Complications as Defined as National Cancer Institute's Common Toxicity Criteria Version 4 Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation [Up to 24 months]
3. Number of Subjects Experienced Change in Erectile Function [3 weeks follow up]
4. Number of Subjects Experienced Change in Urinary Function [3 weeks follow up]
Antrinės rezultatų priemonės
1. Number of Recurrences of Prostate Cancer at the End of 2nd Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation [Up to 24 months]
