N/A
N=27
MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
Stage I Prostate Cancer · Stage II Prostate Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01792024 ↗Enrolled (actual)
27
Serious AEs
7.4%
Results posted
Mar 2018
Primary outcome: Primary: Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment — 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Visualase Thermal Therapy (Device); magnetic resonance imaging (Procedure)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- University of Chicago
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment |
26 | — |
| SECONDARY The Number of Patients With Biopsy Cancer of the Treatment Zone |
3 | — |
| SECONDARY The Total Number of Patients With Any Adverse Events Related to the Treatment |
20 | — |
| SECONDARY Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) |
10; 7; 10 | — |
| SECONDARY Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) |
19; 19; 21 | — |
Summary
This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer
Eligibility Criteria
Inclusion Criteria
- Clinical characteristics:
- Stage T1c or T2a
- Prostate-specific antigen (PSA) 20 ng/ml and clinical stage T1c
- Bone scan if PSA > 10 ng/ml and clinical stage T2
- Biopsy requirements:
- Gleason score 7 or less
- 25% or fewer biopsies with cancer
- At least 12 biopsy cores of the prostate
- Within 12 months of treatment
- Imaging requirements:
- Up to 2 visible magnetic resonance (MR) lesion(s) concordant with sextant of biopsy-detected cancer(s)
- MRI within 6 months of treatment
- Karnofsky performance status of at least 70
- General health is suitable to undergo the planned minimally invasive procedures
- Risks, benefits, and alternatives discussed with informed consent given
Exclusion Criteria
- Previous treatment of prostate cancer with luteinizing hormone releasing hormone (LHRH) agonist/antagonist, chemotherapy, surgery, or radiation
- Presence of 3 or more visible lesions on MRI
- High suspicion of seminal vesicle invasion or lymph node metastases on MRI
- Unable to tolerate MRI (medical device, foreign body, claustrophobia, body habitus, or other)
- Renal insufficiency with estimated glomerular filtration rate (eGFR) < 30 ml/min/body surface area (BSA) based on Modification in Diet Renal Disease equation; inability to safely receive gadolinium contrast for MRI
- History of prior pelvic surgery with surgical clips remaining in situ (e.g., bladder, bowel, internal pelvic organs) that compromise MRI image quality
- Other serious illnesses involving the cardiac, respiratory, central nervous system (CNS), 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
Data sourced from ClinicalTrials.gov (NCT01792024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.