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New treatment option for Prostate Cancer
Official title MRI Guided Focal Laser Ablation of Prostate Cancer
ClinicalTrials.gov ID: NCT03650595
What this study is testing
- What it's testing
- This clinical research study is designed to determine the ability of in bore MRI guided Focal Laser Ablation (MRgFLA) in patients with early stage carcinoma of prostate. The results will be evaluated by repeated MRI and prostate biopsy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80, men only
You may be able to join if
- Men 40-80 years of age
- Histologically proven low-intermediate risk prostate carcinoma; (Gleason score ≤ 7, primary grade ≤ 4;)
- Prostate cancer clinical stage T1c and T2
- MR site suspicious for cancer or cancer mapped to one lobe of the prostate using the 3D hybrid TRUS device
- Size of MR visible tumor \<20mm
You likely can't join if
- Medically unfit for focal therapy of the prostate
- Patients who are unwilling or unable to give informed consent;
- Patients who have received androgen suppression therapy
- Patients who have received or are receiving chemotherapy for prostate carcinoma;
- Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including HIFU, TUNA, RITA, microwave...
- Patients who have undergone radiation therapy for prostate cancer or to the pelvis
See the full eligibility criteria
- Men 40-80 years of age
- Histologically proven low-intermediate risk prostate carcinoma; (Gleason score ≤ 7, primary grade ≤ 4;)
- Prostate cancer clinical stage T1c and T2
- MR site suspicious for cancer or cancer mapped to one lobe of the prostate using the 3D hybrid TRUS device
- Size of MR visible tumor \<20mm
- Suspicious site on Prostate MRI must coincide with sector positive for cancer on biopsy
- Prostate specific antigen (PSA) level \<15 ng/mL
- IPSS, ICIQ-UI-SF, IIEF complete prior to procedure
- Life expectancy of greater than 10 years, based on co-morbidity not related to prostate cancer.
- Medically unfit for focal therapy of the prostate
- Patients who are unwilling or unable to give informed consent;
- Patients who have received androgen suppression therapy
- Patients who have received or are receiving chemotherapy for prostate carcinoma;
- Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment
- Patients who have undergone radiation therapy for prostate cancer or to the pelvis
- Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or...
- Patients with a history of noncompliance with medical therapy and/or medical recommendations;
- Patients who are unwilling or unable to complete the patient self-assessment questionnaires;
- Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
- Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days;
- Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
- Any condition, or history of illness that, in the opinion of the investigator will confound or increase the patient risk during the study
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.