Trial Outcomes & Findings for MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer (NCT NCT01792024)

NCT ID: NCT01792024

Last Updated: 2018-03-13

Results Overview

The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: At 3 months after ablation
• Results posted on: 2018-03-13

Participant Flow

Participant milestones

Measure	Treatment (LITT) Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer

Baseline characteristics by cohort

Measure	Treatment (LITT) n=27 Participants Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 3 months after ablation

The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.

Outcome measures

Measure	Treatment (LITT) n=27 Participants Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT
Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment	26 Participants

SECONDARY outcome

Timeframe: At 12 months

A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.

Outcome measures

Measure	Treatment (LITT) n=27 Participants Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT
The Number of Patients With Biopsy Cancer of the Treatment Zone	3 Participants

SECONDARY outcome

Timeframe: 1,3, and 12 month after treatment and up to 12 months

Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Outcome measures

Measure	Treatment (LITT) n=27 Participants Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT
The Total Number of Patients With Any Adverse Events Related to the Treatment	20 Participants

SECONDARY outcome

Timeframe: At 1,3 and 12 months

International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.

Outcome measures

Measure	Treatment (LITT) n=27 Participants Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) At 1 month	10 units on a scale Interval 1.0 to 21.0
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) At 3 month	7 units on a scale Interval 0.0 to 25.0
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) At 12 month	10 units on a scale Interval 1.0 to 26.0

SECONDARY outcome

Timeframe: At 1,3 and 12 months

Sexual Health Inventory Score in Men (SHIM) measures sexual health and erectile function and it ranged 1 to 25. Lower values are considered better outcome.

Outcome measures

Measure	Treatment (LITT) n=27 Participants Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) At 12 month	21 units on a scale Interval 3.0 to 25.0
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) At 1 month	19 units on a scale Interval 1.0 to 25.0
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) At 3 month	19 units on a scale Interval 1.0 to 25.0

Adverse Events

Treatment (LITT)

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (LITT) n=27 participants at risk Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT
Injury, poisoning and procedural complications Bleeding per rectum	3.7% 1/27 • 1,3 and 12 months after treatment
General disorders Fever	3.7% 1/27 • 1,3 and 12 months after treatment

Other adverse events

Measure	Treatment (LITT) n=27 participants at risk Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT
Immune system disorders Allergic reaction	7.4% 2/27 • 1,3 and 12 months after treatment
Reproductive system and breast disorders Erectile dysfunction	18.5% 5/27 • 1,3 and 12 months after treatment
Renal and urinary disorders Hematuria	33.3% 9/27 • 1,3 and 12 months after treatment
Renal and urinary disorders Renal and urinary disorders - Other, specify	11.1% 3/27 • 1,3 and 12 months after treatment
Reproductive system and breast disorders Scrotal pain	7.4% 2/27 • 1,3 and 12 months after treatment
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	22.2% 6/27 • 1,3 and 12 months after treatment
Renal and urinary disorders Urinary frequency	7.4% 2/27 • 1,3 and 12 months after treatment
Renal and urinary disorders urinary incontinence	7.4% 2/27 • 1,3 and 12 months after treatment
Renal and urinary disorders Urinary retention	14.8% 4/27 • 1,3 and 12 months after treatment

Additional Information

Dr. Aytekin Oto

University of Chicago

Phone: 773-834-7424

Email: aoto@radiology.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place