Microdevice for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Brigham and Women's Hospital

Disqualifiers: Infection, Heart failure, Angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a small, implantable device (Implantable Microdevice) that measures how prostate cancer tumors respond to chemotherapy and other drugs. The goal is to determine if this device can help doctors identify the most effective treatments for individual patients. Participants are divided into two groups: one where the device is placed in the prostate after removal, and another where the device is placed in the tumor before surgery. Men with prostate cancer who are scheduled for surgery and have certain tumor characteristics may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative device.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this microdevice is safe for use in prostate cancer patients?

Research has shown that the tiny device used in this study is quite safe. In one study, researchers placed the device directly into prostate cancer areas without causing serious health problems. Another study found that the device can be inserted and removed without issues, with most patients recovering well. These results suggest that patients tolerate the device well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the implantable microdevice for prostate cancer because it offers a new way to test the effectiveness of multiple drugs directly within the tumor itself. Unlike traditional treatments that require systemic drug delivery, this microdevice can release drugs locally in the tumor, potentially reducing side effects and improving precision in treatment. The ex-vivo approach allows drugs to be tested on tissue outside the body, while the in-vivo arm places devices directly in tumors before surgery, providing real-time insights into how different drugs affect the cancer. This innovative method could lead to more personalized and effective treatment strategies for prostate cancer.

What evidence suggests that this microdevice is effective for prostate cancer?

Research shows that tiny devices implanted in the body can help doctors assess how prostate cancer tumors respond to chemotherapy and other drugs. In this trial, participants in the Ex-Vivo Cohort will have the implantable microdevice placed in prostate tissue removed during routine standard care for radical prostatectomy. Meanwhile, participants in the Surgery Cohort will undergo percutaneous placement of several microdevices in selected tumors before surgery. One study placed 55 of these devices in patients, with 90.1% successfully removed, proving the method's effectiveness. Another study found that these devices can deliver precise drug amounts directly into a tumor, allowing researchers to observe multiple drug effects simultaneously. This helps doctors determine the best treatments for a specific tumor. The technology has also been safely used in patients undergoing regular prostate surgery. Overall, early results suggest this method could more accurately customize treatments for each patient. ^{2 3 5 6 7}

Who Is on the Research Team?

Adam S Kibel, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Microdevice Placement

Placement of MR-guided microdevice in prostate cancer lesions to evaluate drug responses

48 hours

1 visit (in-person)

Surgery and Retrieval

Surgical removal of microdevice along with surrounding tumor tissue

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after microdevice placement and surgery

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Implantable Microdevice

Trial Overview 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.

How Is the Trial Designed?

Group I: Surgery Cohort Experimental Treatment 1 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 Cohort Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The study demonstrated that a novel implantable microdevice (IMD) can be safely implanted and retrieved in patients with non-small cell lung cancer (NSCLC) during surgery, with a 93% retrieval success rate and no severe adverse reactions reported.

The IMD allows for localized delivery of multiple chemotherapeutic agents, showing differential tumor responses to the drugs, which could help tailor personalized treatment regimens based on individual tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Intrathoracic Implantation of Multidrug-Eluting Microdevices for In Situ Chemotherapeutic Sensitivity Testing as Proof of Concept in Nonsmall Cell Lung Cancer. Tsai, LL., Phillips, WW., Hung, YP., et al.[2023]

PSMA-targeted imaging and therapeutics are emerging as promising tools for improving the management of various stages of prostate cancer, including primary, recurrent, and metastatic cases.

A multidisciplinary approach involving nuclear radiology, medical oncology, urology, and radiation oncology is essential to fully realize the potential benefits of PSMA theranostics in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating PSMA-Targeting Theranostics Into Personalized Prostate Cancer Treatment: a Multidisciplinary Perspective. Ng, TSC., Gao, X., Salari, K., et al.[2022]

Citations

1. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004269

Novel Intraprostatic Magnetic Resonance–Guided ... This study represents the first report of the safety and feasibility of using an implantable microdevice (IMD) to assess in situ tumor response ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12335932/

Feasibility of MRI-Guided Transperineal Implantation ... In this study, 55 IMDs were successfully placed in 14 participants, and 90.1% of the IMDs were recovered from prostatectomy specimens. This ...

3. nature.com nature.com/articles/s41587-022-01379-y

A multiplex implantable microdevice assay identifies ... In this study, we integrated high-throughput and high-content techniques—an implantable microdevice to administer multiple drugs into different ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4825177/

An implantable microdevice to perform high-throughput in ... Our fully implanted microscale device is capable of delivering precise doses of different drugs into a tumor for parallel drug efficacy assessments in vivo.

5. researchgate.net researchgate.net/publication/384472110_Novel_intraprostatic_MR-guided_implantation_of_multidrug-eluting_microdevice_for_testing_of_systemic_therapy_agents_in_situ_Proof_of_concept_in_intermediate-_and_high-risk_prostate_cancer

Novel intraprostatic MR-guided implantation of multidrug ... A total of 53 IMDs were implanted (mean 3.8 per patient) and 49 (92%) IMDs were successfully retrieved. All men underwent uncomplicated robotic radical ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39348711/

Proof of Concept in Intermediate-Risk and High-Risk Prostate ... A multidrug IMD can be safely placed percutaneously into MRI-visible lesions before radical prostatectomy, enabling assessment of tumor-specific local response.

7. medpagetoday.com medpagetoday.com/hematologyoncology/prostatecancer/114097

Implant Shows Promise for Tumor-Specific Treatment in ... Percutaneously inserted directly into a prostate cancer lesion, the implantable microdevice (IMD) caused no severe adverse events. Pathology ...