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Trial record 2 of 6 for:    focal ablation | Recruiting Studies | Prostate Cancer | United States

Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

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ClinicalTrials.gov Identifier: NCT02600156
Recruitment Status : Recruiting
First Posted : November 9, 2015
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
David A. Woodrum, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Focal laser ablation of the prostate Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
Study Start Date : September 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Single arm study
MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.
Procedure: Focal laser ablation of the prostate
MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.
Other Name: Visualase Laser Ablation




Primary Outcome Measures :
  1. Success rate [ Time Frame: 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 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Short- and mid-term ablative success [ Time Frame: 3 years ]
    To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600156


Contacts
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Contact: Jennifer Murphy 507-538-0540 Murphy.Jennifer@mayo.edu
Contact: Desirae Howe-Clayton 507-255-0111 Howe.Desirae@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Murphy    507-538-0540    Murphy.Jennifer@mayo.edu   
Principal Investigator: David A. Woodrum, M.D., Ph.D         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: David Woodrum, MD, PhD Mayo Clinic
Additional Information:
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Responsible Party: David A. Woodrum, David A. Woodrum, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02600156    
Other Study ID Numbers: 14-005500
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases