MR Image Guided Therapy in Prostate Cancer

Phase 2

Completed

Conditions: Prostate Cancer
Prostatic Neoplasms

Interventions: Device: Visualase Thermal Therapy System

Registration Number: NCT01377753

Lead Sponsor: National Cancer Institute (NCI)

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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1/Magnetic Resonance (MR) Thermal Image Guided Laser Ablation	Visualase Thermal Therapy System	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One Grade 1 Adverse Event, More Than One Grade 1 Adverse Event, and One Grade 2 Adverse Event	For all participants enrolled over the time frame of the study including follow up time is approximately 65 months	Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild and Grade 2 is moderate.

Secondary Outcome Measures

Name	Time	Method
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.	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).
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.	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.
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.	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.
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.	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).
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.	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.