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New treatment option for Prostate Cancer
Official title Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
ClinicalTrials.gov ID: NCT04808427
What this study is testing
- What it's testing
- Background: The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- people must have prostate cancer amenable for ultrasound ablation defined as:
- diagnosed by transrectal ultrasound-guided prostate biopsy via standard 12 core biopsy and targeted biopsy of any MRI-visible or tracked lesions...
- Gleason Score \<= 7;
- MRI-visible or MRI-tracked prostate cancer. This includes prostate cancer found on targeted biopsy of MRI-visible or MRI-tracked lesion...
- organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI. Note: Participants after prostate cancer treatment with local...
You likely can't join if
- Targeted lesion ablation length from apex to base of \>5 cm or lesion extending \>3 cm from the urethra.
- Target ablation volume greater than 100 ml.
- Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target.
- Participants are unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil...
- Acute urinary tract infection
- Lower urinary tract symptoms defined by an IPSS \> 20
See the full eligibility criteria
- people must have prostate cancer amenable for ultrasound ablation defined as:
- diagnosed by transrectal ultrasound-guided prostate biopsy via standard 12 core biopsy and targeted biopsy of any MRI-visible or tracked lesions; pathological diagnosis must be confirmed by Laboratory of Pathology, NCI;
- Gleason Score \<= 7;
- MRI-visible or MRI-tracked prostate cancer. This includes prostate cancer found on targeted biopsy of MRI-visible or MRI-tracked lesion. Histologically positive standard biopsy cores of Grade Group \>= 2 prostate cancer...
- organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible.
- PSA \ 20 with a PSA density \<0.15.
- Adults (\>= 18 years of age)
- Participants must have adequate organ and marrow function as defined below: Platelets \>= 50,000/mcL Hemoglobin \>= 8 g/dL Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\ \>=...
- people must be able to understand and willing to sign a written informed consent document.
- people must be co-enrolled to NCI protocol 16-C-0010 "Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue."
- Targeted lesion ablation length from apex to base of \>5 cm or lesion extending \>3 cm from the urethra.
- Target ablation volume greater than 100 ml.
- Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target.
- Participants are unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc.)
- Acute urinary tract infection
- Lower urinary tract symptoms defined by an IPSS \> 20
- Participants with uncontrolled coagulopathies (including liver dysfunction, or untreated hereditary coagulopathies which have a standard of care treatment) per surgeon discretion based on bleeding risk.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. 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.