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AzTrials

Prostate CancerPhase 2NCT01377753

MR Image Guided Therapy in Prostate Cancer

A Phase 2 study testing Visualase Thermal Therapy System in people with Prostate Cancer and Prostatic Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Prostatic Neoplasms
What is being tested?
Visualase Thermal Therapy System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
12 Aug 2011to 31 Jul 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men greater than 18 years of age
  • Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on magnetic resonance (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 magnetic resonance imaging (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
Show all 10Show fewer
  • Metastatic Disease work up as per National Comprehensive Cancer Network (NCCN) guidelines (www.nccn.org). Bone scan indicated to r/o metastatic disease if [clinical T1 and prostate-specific antigen (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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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 Principal Investigator (PI): involving the cardiac, respiratory, central nervous system (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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: MR Image Guided Focal Therapy in Prostate Cancer

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.
Read more

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 follow-up 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.
Read the 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 magnetic resonance (MR) visible prostate cancer.

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 National Comprehensive Cancer Network (NCCN).org prostate cancer guidelines
  • Prostate-specific antigen (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
Being tested
Visualase Thermal Therapy System
Keywords
Toxicity, Thermal Ablation/Damage, Localized Prostate Cancer, Laser Ablation, PSA Levels, Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visualase Thermal Therapy SystemDevice

    Used for performing Laser Induced Thermal Therapy to destroy malignant or unwanted tissue by delivering laser energy sufficient to cause coagulation and necrosis of the tissue.

Study groups in NCT01377753
Study groupRoleWhat they receive
Arm 1/Magnetic Resonance (MR) Thermal Image Guided Laser AblationExperimentalEligible subjects will undergo MR thermal image guided laser ablation of all biopsy proven areas of prostate cancer using one or multiple laser probes during a single procedure lasting approximately two hours in duration.
Receives: Device: Visualase Thermal Therapy System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With One Grade 1 Adverse Event, More Than One Grade 1 Adverse Event, and One Grade 2 Adverse Event

    Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild and Grade 2 is moderate.

    Measured: For all participants enrolled over the time frame of the study including follow up time is approximately 65 months

Secondary outcomes (5)

  1. Mean Change in Prostate Specific Antigen (PSA) From Baseline Prior to Salvage Treatment or at the Conclusion of the Study Time Frame if There Was No Salvage Treatment

    A single difference was calculated between the PSA value measured at baseline and either (1) the PSA value measured just prior to a salvage treatment or (2) the PSA value measured at the conclusion of the study time frame (if no salvage treatment was necessary).

    Measured: From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.

  2. Mean Change in Prostate Specific Antigen Density (PSAD) From Baseline During Study Time Frame

    A single difference was calculated between the PSA density at baseline and either (1) the PSA density just prior to a salvage treatment or (2) the PSA density at the conclusion of the study time frame (if no salvage treatment was necessary).

    Measured: From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.

  3. Mean Change in Quality of Life (QoL) From Baseline Prior to Salvage Treatment or at the Conclusion of the Study Time Frame if There Was No Salvage Treatment

    The outcome of laser ablation for treatment of prostate cancer for each participant was assessed by Quality of Life (QoL) questionnaire at clinic appointments. Specifically, patients are asked "How would you feel if you had to live with your urinary condition the way it is now, no better, no worse, for the rest of your life?" A score is then provided on a scale of 0 (delighted) to 5 (unhappy). The change in QoL from baseline was determined by calculating the difference between the baseline score and either the score just prior to a salvage treatment or the last measurement obtained at the conclusion of the study time frame.

    Measured: From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.

  4. Mean Change in International Prostate Symptom Score (IPSS) From Baseline Over Follow-Up Visits Prior to Salvage Treatment or Across All Follow-up Visits During Study Time Frame if There Was No Salvage Treatment

    The outcome of laser ablation for treatment of prostate cancer for each participant was assessed by International Prostate Symptom Score (IPSS) questionnaire at clinic appointments. Specifically, patients are asked about seven domains of lower urinary tract symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) and provide scores for each domain from 0 (not at all) to 5 (almost always) to describe how often they experience each symptom. Therefore, each domain is scored from 0 to 5. The scores are then totaled (summed). Therefore, the total score could range from 0 to 35. For both individual domain scores and the total score, a higher score indicates more severe symptoms. The change in IPSS from baseline was determined by calculating the difference between the baseline score and either the score just prior to a salvage treatment or the last measurement obtained at the conclusion of the study time frame.

    Measured: From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.

  5. Mean Change in Sexual Health Inventory for Men (SHIM) From Baseline Over Follow-Up Visits Prior to Salvage Treatment or Across All Follow-up Visits During Study Time Frame if There Was No Salvage Treatment

    The outcome of laser ablation for treatment of prostate cancer for each participant was assessed by Sexual Health Inventory for Men (SHIM) questionnaire at clinic appointments. Specifically, patients are asked six questions about sexual health and erectile function and provide scores for each question from 0 (not at all) to 5 (almost always) to describe how often they experience each symptom. Therefore, each question is scored from 0 to 5. The scores are then totaled (summed). Therefore, the total score could range from 0 to 30. For both individual question scores and the total score a lower score indicates more severe symptoms. The mean change in SHIM from baseline was determined by calculating the difference between the baseline score and either the score just prior to a salvage treatment or the last measurement obtained at the conclusion of the study time frame.

    Measured: From date participant is enrolled to completion of post-ablation monitoring, approximately 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2011 (estimated)
  2. Study start12 Aug 2011
  3. Primary completion1 Jan 2017
  4. Study completion31 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01377753
Sponsor's protocol ID
110158
Other IDs
11-C-0158
Status last verified
Jan 2022
First submitted
18 Jun 2011
Last updated
1 Feb 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Andriole GL, Crawford ED, Grubb RL 3rd, Buys SS, Chia D, Church TR, Fouad MN, Gelmann EP, Kvale PA, Reding DJ, Weissfeld JL, Yokochi LA, O'Brien B, Clapp JD, Rathmell JM, Riley TL, Hayes RB, Kramer BS, Izmirlian G, Miller AB, Pinsky PF, Prorok PC, Gohagan JK, Berg CD; PLCO Project Team. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009 Mar 26;360(13):1310-9. doi: 10.1056/NEJMoa0810696. Epub 2009 Mar 18.

    PubMed 19297565

  • Adolfsson J. Watchful waiting and active surveillance: the current position. BJU Int. 2008 Jul;102(1):10-4. doi: 10.1111/j.1464-410X.2008.07585.x. Epub 2008 Apr 14. No abstract available.

    PubMed 18422774

  • Schroder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, Kwiatkowski M, Lujan M, Lilja H, Zappa M, Denis LJ, Recker F, Berenguer A, Maattanen L, Bangma CH, Aus G, Villers A, Rebillard X, van der Kwast T, Blijenberg BG, Moss SM, de Koning HJ, Auvinen A; ERSPC Investigators. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009 Mar 26;360(13):1320-8. doi: 10.1056/NEJMoa0810084. Epub 2009 Mar 18.

    PubMed 19297566

  • Mehralivand S, George AK, Hoang AN, Rais-Bahrami S, Rastinehad AR, Lebastchi AH, Ahdoot M, Siddiqui MM, Bloom J, Sidana A, Merino MJ, Choyke PL, Shih JH, Turkbey B, Wood BJ, Pinto PA. MRI-guided focal laser ablation of prostate cancer: a prospective single-arm, single-center trial with 3 years of follow-up. Diagn Interv Radiol. 2021 May;27(3):394-400. doi: 10.5152/dir.2021.20095.

    PubMed 34003127

  • Esengur OT, Gelikman DG, Law YM, Yilmaz EC, Harmon SA, Merino MJ, Gurram S, Choyke PL, Wood BJ, Pinto PA, Turkbey B. Comparison of Transatlantic Recommendations for Prostate Gland Evaluation with MRI after Focal Therapy (TARGET) and Prostate Imaging after Focal Ablation (PI-FAB) for Detecting Recurrent Prostate Cancer at Prostate MRI. Acad Radiol. 2025 Feb;32(2):855-863. doi: 10.1016/j.acra.2024.09.051. Epub 2024 Oct 19.

    PubMed 39426916

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Visualase Thermal Therapy System in people with Prostate Cancer and Prostatic Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One Grade 1 Adverse Event, More Than One Grade 1 Adverse Event, and One Grade 2 Adverse Event (time frame: For all participants enrolled over the time frame of the study including follow up time is approximately 65 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01377753, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.

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MR Image Guided Therapy in Prostate Cancer | AzTrials