Focal Laser Ablation of Prostate Cancer Tumors
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 04/30/2020 |
| Pirmasis pateikimas: | 09/03/2015 |
| Numatytas registravimas pateiktas: | 11/04/2015 |
| Pirmas paskelbtas: | 11/08/2015 |
| Paskutinis atnaujinimas pateiktas: | 05/25/2020 |
| Paskutinis atnaujinimas paskelbtas: | 05/26/2020 |
| Faktinė studijų pradžios data: | 08/31/2015 |
| Numatoma pirminio užbaigimo data: | 11/30/2020 |
| Numatoma studijų užbaigimo data: | 11/30/2022 |
Būklė ar liga
Intervencija / gydymas
Procedure: Single arm study
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| 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. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 45 Years Į 45 Years |
| Tinkamos studijoms lytys | Male |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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. |
Rezultatas
Pirminės rezultatų priemonės
1. Success rate [3 years]
2. Incidence of treatment emergent adverse events [3 years]
Antrinės rezultatų priemonės
1. Short- and mid-term ablative success [3 years]
