Phase II Laser Focal Therapy of Prostate Cancer

NCT02243033 | Active Not Recruiting

• 2 other identifiers: DMI-Laser-001WIRB Pr. No.: 20140945
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Target recruitment: 1000 subjects. The purpose of this research study is to continue to investigate the safety and effectiveness of using MR (magnetic resonance) guided laser focal therapy for prostate cancer and to evaluate oncologic control over 20 years. We hypothesize that laser focal therapy can be used to achieve oncologic control in carefully selected patients. MR uses large magnets to produce pictures of areas/organs inside the body. The laser uses light to heat a target area to try to destroy cancerous cells. The laser system that will be used is called the Visualase® Thermal Therapy System. This system has been used for the treatment of brain, bone (spine), thyroid, and liver cancers. However; this study is the first time this system has been studied for use in the treatment of prostate cancer with a trans-rectal approach. MR-guided biopsies and laser applicator placement will be performed using the Invivo DynaTRIM trans-rectal biopsy guidance system. This system is cleared (approved) by the U.S. Food and Drug Administration (FDA) for such uses.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Focal therapy; Laser therapy; Transrectal; MRI-guided

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events

  Number of subjects reporting serious adverse events.

  1 yr. post treatment

Secondary Outcomes (1)

• Efficacy of treatment

  1 yr. post treatment

Other Outcomes (3)

• Time to biochemical recurrence

  Up to 20 years

• Time to metastasis

  Up to 20 years

• Cause of death

  Up to 20 years

Study Arms (1)

Visualase

MR-guided laser focal therapy

Device: MR-guided laser focal therapy

Interventions

MR-guided laser focal therapy DEVICE

Placement of laser applicator under MRI guidance and real-time MR thermal imaging of tissue necrosis.

Also known as: Visualase, Tranberg

Visualase

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with prostate cancer

You may qualify if:

• Treatment Naïve patients:
• 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 less.
• Three or fewer biopsy cores with prostate cancer.
• PSA density not exceeding 0.375.
• One, two, or three tumor suspicious regions identified on multiparametric MRI.
• Negative radiographic indication of extra-capsular extent.
• Karnofsky performance status of at least 70.
• Estimated survival of 5 years or greater, as determined by treating physician.
• Tolerance for anesthesia/sedation.
• Ability to give informed consent.
• At least 6 weeks since any previous prostate biopsy.
• MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less.

You may not qualify if:

• Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
• Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
• History of other primary non-skin malignancy within previous three years.
• Diabetes
• Smoker

Sponsors & Collaborators

• HALO Diagnostics: lead

Study Sites (1)

Desert Medical Imaging

Indian Wells, California, 92210, United States

Location

Related Publications (4)

• Greenwood, B. et al.: Transrectal interventional MRI: initial prostate biopsy experience. SPIE Proceedings, 2010.

  BACKGROUND

• Hakimi AA, Feder M, Ghavamian R. Minimally invasive approaches to prostate cancer: a review of the current literature. Urol J. 2007 Summer;4(3):130-7.

  PMID: 17987573 BACKGROUND

• Menon M, Tewari A, Peabody JO, Shrivastava A, Kaul S, Bhandari A, Hemal AK. Vattikuti Institute prostatectomy, a technique of robotic radical prostatectomy for management of localized carcinoma of the prostate: experience of over 1100 cases. Urol Clin North Am. 2004 Nov;31(4):701-17. doi: 10.1016/j.ucl.2004.06.011.

  PMID: 15474597 BACKGROUND

• Valerio M, Emberton M, Ahmed HU. Focal therapy will become a standard option for selected men with localized prostate cancer. J Clin Oncol. 2014 Nov 10;32(32):3680-1. doi: 10.1200/JCO.2014.56.7792. Epub 2014 Aug 18. No abstract available.

  PMID: 25135989 BACKGROUND

Related Links

• HALODx

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John F. Feller, MD

  HALO Diagnostics

  PRINCIPAL INVESTIGATOR

• Bernadette M. Greenwood, MSc

  HALO Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 17, 2014
• Study Start: May 1, 2016
• Primary Completion (Estimated): May 1, 2036
• Study Completion (Estimated): November 1, 2036
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Bi-annaually at the meetings of the International Laser Network until study closure.
• Access Criteria: Scientists and physicians studying or performing laser focal therapy.

Locations

US (1)