Microdevice for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAdam S Kibel, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

In this research study, is assessing the feasibility of using an MR-guided implantable microdevice to measure tumor response to chemotherapy and other clinically relevant drugs in participants that have prostate cancer and are scheduled for a radical prostatectomy. The name of the study intervention involved in this study is: - Implantation of a MR-guided microdevice

Research Team

Adam S Kibel, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

Inclusion Criteria

I agree to have my genes sequenced for research.

My case has been reviewed by urology and radiology specialists.

I have had a detailed prostate MRI scan.

See 8 more

Exclusion Criteria

I do not have any unmanaged ongoing illnesses.

I have a bleeding or clotting issue that makes surgery risky.

Unwillingness to sign informed consent

Treatment Details

Interventions

Implantable Microdevice (Other)

Trial OverviewThe 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.

Participant Groups

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