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Microdevice for Prostate Cancer
Phase 1
Waitlist Available
Led By Adam S Kiibel, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be 22 years of age or older
Planned radical prostatectomy for prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
Study Summary
This trial is testing the feasibility of using an MR-guided microdevice to measure tumor response to chemotherapy and other clinically relevant drugs in participants with prostate cancer who are scheduled for a radical prostatectomy.
Who is the study for?
This trial is for men aged 22 or older with intermediate to high-risk prostate cancer, scheduled for radical prostatectomy. They must understand and sign consent, be medically stable for surgery, have certain blood counts within safe ranges, and an MRI-visible lesion. Men with uncontrolled illnesses or bleeding disorders that increase surgical risk are excluded.Check my eligibility
What is being tested?
The study tests the feasibility of a MR-guided microdevice implanted into the tumor to measure how well it responds to chemotherapy drugs before prostate removal surgery. The device will provide information on drug effectiveness directly in the tumor site.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with implantable devices such as infection at the implantation site, bleeding, discomfort or pain where the device is placed, and possible allergic reactions to materials in the microdevice.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
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I am scheduled for a major surgery to remove my prostate due to cancer.
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My prostate cancer is classified as intermediate or high risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with successful surgical Placement and retrieval of Microdevice
Number of participants with adverse events as defined in the CTCAE v4.0
Secondary outcome measures
Biomarkers of drug response
Genetic features of the tumor tissue
Intratumor heterogeneity in drug response
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Surgery CohortExperimental Treatment1 Intervention
Participant eligibility for intervention and selection of lesion for device placement
- Surgery Cohort will undergo percutaneous placement of several microdevices in a selected tumor(s) prior to surgery. The microdevice in the surgery cohort will dwell in the tumor tissue for approximately 48 hours to allow time for tissue effects of the drugs in the microdevice reservoirs.
Placement of at least 1, and up to 6, microdevices depending on the number of lesions, size and accessibility
Extirpative surgery will proceed according to standard-of-care procedures. The microdevice(s) will be removed surgically along with surrounding tumor tissue.
Standard of care treatment and follow-up of clinical course
Group II: Ex-Vivo CohortExperimental Treatment1 Intervention
Each participant will undergo a screening process to determine their eligibility for microdevice placement, consisting of the following items:
Routine standard of care for radical prostatectomy.
Placement of implantable microdevice with multiple miniature drug reservoirs but no drug in prostate that have been removed
Ex vivo image guided removal using retrieval device
Standard of Care Treatment and follow-up of clinical course
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,612 Previous Clinical Trials
11,470,540 Total Patients Enrolled
21 Trials studying Prostate Cancer
32,737 Patients Enrolled for Prostate Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,913 Total Patients Enrolled
76 Trials studying Prostate Cancer
16,070 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,237 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,060 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to have my genes sequenced for research.I do not have any unmanaged ongoing illnesses.My case has been reviewed by urology and radiology specialists.I have had a detailed prostate MRI scan.I am 22 years old or older.I am scheduled for a major surgery to remove my prostate due to cancer.I have a bleeding or clotting issue that makes surgery risky.I can understand and am willing to sign the consent form, either in person or via a secure video call.I am medically fit for surgery and other standard procedures.My prostate cancer is classified as intermediate or high risk.I agree to avoid fathering a child or donate sperm during and for 28 days after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Ex-Vivo Cohort
- Group 2: Surgery Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies open for participants in this research endeavor?
"At present, the information held on clinicaltrials.gov indicates that this medical trial is no longer recruiting patients; it was first published in June of 2020 and last amended in August 2022. Although enrollment has closed, there are still 1,322 studies actively seeking participants."
Answered by AI
Has the Microdevice been approved by the FDA for commercial use?
"Microdevice received an estimated safety rating of 1 due to its status as a Phase 1 trial. This implies that there is only limited data available on the efficacy and safety of this intervention."
Answered by AI
What purpose does this experiment aim to fulfill?
"The primary outcome to be assessed over 48 hours is the number of participants that experience adverse events as defined in CTCAE v4.0. Secondary objectives include establishing a correlation between genetic features and response to drug, measuring biomarkers of drug responsiveness within adjacent tumor tissue, and evaluating intratumor heterogeneity in drug efficacy using multiple microdevices at different locations. Statistical analyses will leverage two-sided alpha = 0.05 with 95% confidence intervals reported alongside any point estimates."
Answered by AI
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