MR Image Guided Therapy in Prostate Cancer

NCT01377753 | Completed Phase 2 Results FDA Device

• 2 other identifiers: 11015811-C-0158
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Cancer; Prostatic Neoplasms

Keywords

Toxicity; Thermal Ablation/Damage; Localized Prostate Cancer; Laser Ablation; PSA Levels; Prostate Cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• 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

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

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

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

• 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

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

• 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

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

• 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

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

Other Outcomes (1)

• Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

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

Study Arms (1)

Arm 1/Magnetic Resonance (MR) Thermal Image Guided Laser Ablation

EXPERIMENTAL

Eligible 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.

Device: Visualase Thermal Therapy System

Interventions

Visualase Thermal Therapy System DEVICE

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.

Arm 1/Magnetic Resonance (MR) Thermal Image Guided Laser Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• 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.

  PMID: 19297565 BACKGROUND

• 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.

  PMID: 18422774 BACKGROUND

• 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.

  PMID: 19297566 RESULT

• 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.

  PMID: 34003127 RESULT

Related Links

• NIH Clinical Center Detailed Web Page

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

Results Point of Contact

• Title: Dr. Peter Pinto
• Organization: National Cancer Institute

pintop@mail.nih.gov

240-760-6249

Study Officials

• Peter A Pinto, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2011
• First Posted: June 21, 2011
• Study Start: August 12, 2011
• Primary Completion: January 1, 2017
• Study Completion: July 31, 2018
• Last Updated: February 1, 2022
• Results First Posted: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)