Trial Outcomes & Findings for MR Image Guided Therapy in Prostate Cancer (NCT NCT01377753)

MR Image Guided Therapy in Prostate Cancer

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

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).

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).

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.

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.

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.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.