MR Image Guided Therapy in Prostate Cancer

• ClinicalTrials.gov Identifier: NCT01377753
• Recruitment Status: Completed
• First Posted: June 21, 2011
• Last Update Posted: March 24, 2021
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description

Brief 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. 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 or disease	Intervention/treatment	Phase
Prostate Cancer; Prostatic Neoplasms	Device: Visualase Thermal Therapy System	Phase 2

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MR Image Guided Focal Therapy in Prostate Cancer
• Actual Study Start Date: August 12, 2011
• Actual Primary Completion Date: January 1, 2017
• Actual Study Completion Date: July 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Eligible subjects will undergo MRthermal 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.	Device: Visualase Thermal Therapy System; 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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Decrease of enhancement on MP MRI at various timepoints,Follow up systematic core biopsy of the prostate at 1, 2, and 3 (optional) years showing no evidence of invasive prostate cancer in the region of laser ablation.Follow up DRE and physical exam at 3, 6, 12, 18, 24 months and yearly for 3 years. This should show no palpable disease, if disease is detected then further workup with one of the above mentioned tests will be performed,PSADT

Secondary Outcome Measures :

1. tolerability of treatment [ Time Frame: 3 years ]
   evaluate tolerability of treatment
2. outcome of laser ablation [ Time Frame: 3 years ]
   Determine outcome of laser ablation for treatment of prostate cancer using serial PSA, PSA density, changes in imaging, IPSS, and SHIM

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

Locations

United States, Maryland

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Peter A Pinto, M.D.; National Cancer Institute (NCI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

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. Erratum in: N Engl J Med. 2009 Apr 23;360(17):1797.

Schröder 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, Määttänen 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.

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. Review.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT01377753
• Other Study ID Numbers: 110158; 11-C-0158
• First Posted: June 21, 2011
• Last Update Posted: March 24, 2021
• Last Verified: September 8, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

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; Prostatic Diseases