MR Image Guided Therapy in Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01377753
First received: June 18, 2011
Last updated: May 14, 2014
Last verified: February 2014
  Purpose

Background:

- One way to treat prostate cancer is to use a laser to direct extreme heat to a small area of the prostate. The heat destroys tumor cells but does not affect healthy tissue. Doctors want to see if magnetic resonance imaging (MRI) can be used to improve this treatment. MRI will be used to help locate tumor cells and guide the laser during surgery. However, MRI-guided laser therapy has not been used to treat many people with prostate cancer. More studies are needed to see whether it can destroy tumor cells permanently.

Objectives:

- To test the safety and effectiveness of treating prostate tumors with laser therapy guided by magnetic resonance imaging.

Eligibility:

- Men at least 18 years of age who have prostate cancer that can be seen with an MRI and has not spread to other parts of the body.

Design:

  • Participants will be screened with a physical exam and medical history. They will also have blood tests and imaging studies, and will complete questionnaires about their health.
  • Participants will have the MRI-guided laser treatment in the hospital. The doctor will use the MRI to control how much energy is delivered by the laser and how much tissue is destroyed. The entire procedure usually takes from 1.5 to 3 hours.
  • After the treatment, participants will have a catheter put in to keep the bladder emptied. The catheter will stay in for 1 to 7 days. Drugs to prevent infection and bladder spasms will be given. Participants will leave the hospital once they are well enough to go home.
  • Participants will have followup visits 3, 6, 9, 12, 18, 24, and 36 months after the therapy. They will have physical exams, and blood and urine tests. They will also answer questionnaires. Participants will have MRI scans 6, 12, 24, and 36 months after the therapy. They will have a prostate biopsy to see if there is any tumor every 12 months for the first 2 years. Another biopsy may be done in the third year.

Condition Intervention Phase
Prostate Cancer
Prostatic Neoplasms
Device: Visualase Thermal Therapy System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MR Image Guided Focal Therapy in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To determine feasibility and safety of magnetic resonance image-guided focal laser ablation of biopsy confirmed and MR visible prostate cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate tolerability of treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine changes in imaging and biopsy characteristics after thermal ablation of localized prostate cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: May 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Visualase Thermal Therapy System
    N/A
Detailed Description:

Background:

  • Pilot study is designed to evaluate the safety and feasibility of thermal laser ablation of focal prostate tumors.
  • Prostate cancer is relatively slow growing, with doubling times for local tumors estimated at 2 to 4 years.
  • Some prostate cancers prove to be small, low grade, and noninvasive and they appear to pose little risk to the life or health of the host. Recent patient series suggest that 20% to 30% of men undergoing radical prostatectomy have pathologic features in the radical prostatectomy specimen consistent with an insignificant or indolent cancer which poses little threat to life or health.
  • We propose that patients with low volume and low grade disease can be best served with focal ablation of the visible prostate cancer without the side effects of urinary incontinence and erectile dysfunction associated with radiation therapy or radical surgery.

Objectives:

Primary Objective:

-To determine feasibility and safety of magnetic resonance image-guided focal laser ablation of biopsy confirmed and MR visible prostate cancer.

Secondary Objective:

  • To evaluate tolerability of treatment
  • To determine changes in imaging and biopsy characteristics after thermal ablation of localized prostate cancer
  • To obtain preliminary data, as a follow-up to this study, regarding the effect of thermal ablation using Visualase on short and long term complication rate.
  • To compare Visualase estimates of thermal damage to post contrast MRI images.
  • Determine outcome of laser ablation for treatment of prostate cancer using serial PSA, PSA density, changes in imaging, IPSS, and SHIM.

Eligibility:

  • Greater than 18 years of age
  • Organ confined prostate cancer, observed on MR, and confirmed by Transrectal biopsy
  • Preoperative workup as dictated by the NCCN.org prostate cancer guidelines
  • PSA < 15 ng or PSA density < 0.15 ng/ml in patients with a PSA > 15 ng

Design:

  • Pilot study, testing feasibility, safety and tolerability of thermal ablation of focal prostate cancer
  • It is anticipated that 15 patients will be accrued for this study
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Men greater than 18 years of age
  • Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging
  • Prostate cancer is diagnosed by transrectal ultrasound guided standard 12 core biopsy or MR image guided biopsies

    • Gleason Score less than or equal to 7 (3+4), less than or equal to 3 cores positive in a standard 12 core biopsy or less than or equal to 4 cores positive on MR image guided biopsy where in 2 cores are taken from each of the two MRI target lesions
    • If the standard biopsy cores are positive, they must be from the same location in the prostate as MR Lesion was biopsied and proven to be cancer. (Left / Right, Base, Mid Gland, Apex).
  • MRI obtained within 6 months of ablation
  • Metastatic Disease work up as per NCCN guidelines (www.nccn.org) Bone scan indicated to r/o metastatic disease if [clinical T1 and PSA > 20 or T2 and PSA > 10]
  • PSA less than or equal to 15 ng/ml or PSA density less than or equal to 0.15 ng/ml(2) in patients with a PSA > 15 ng/ml
  • The patient has given written informed consent after the nature of the study and alternative treatment options have been explained.
  • Patients who present with local recurrence or residual tumor after prostate cancer treatment which is visible on MRI.

EXCLUSION CRITERIA:

  • The presence of 3 or more MR Visible lesions positive on biopsy
  • The presence of extra capsular, seminal vesical invasion or metastatic disease.
  • Patient is unable to tolerate MRI (foreign body, i.e. pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc )
  • Patient with inability to follow up
  • Acute urinary tract infection
  • Lower urinary tract symptoms defined by a International Prostate symptom score (IPSS) > 20
  • Patients with renal insufficiency with an estimated glomerular filtration (EGF) < = 30 are excluded, due to they will not be able to undergo gadolinium enhance MRI.
  • Patients with Uncontrolled Coagulopathies who are at increased risk of bleeding.
  • Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes.
  • Other serious illnesses according to the PI: involving the cardiac, respiratory, CNS, renal or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study.
  • A Standard 12 core biopsy positive for cancer with no corresponding MR targeted lesion positive for cancer in the same general region of the prostate (Right Apex, Right Mid Gland, Right Base, Left Base, Left Mid Gland, Left Apex)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377753

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Peter A Pinto, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01377753     History of Changes
Other Study ID Numbers: 110158, 11-C-0158
Study First Received: June 18, 2011
Last Updated: May 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Toxicity
Thermal Ablation/Damage
Localized Prostate Cancer
Laser Ablation
PSA Levels
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 01, 2014