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

35 Participants Needed

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

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 data supports the effectiveness of the treatment Implantable Microdevice for prostate cancer?

Research on similar microdevice technologies, like the NanoVelcro Chip, shows that they can effectively capture and monitor circulating tumor cells (CTCs) in prostate cancer patients, which helps track treatment response and disease progression. This suggests that implantable microdevices could also be effective in assessing and potentially improving treatment outcomes for prostate cancer. ^{1 2 3 4 5}

How is the Implantable Microdevice treatment for prostate cancer different from other treatments?

The Implantable Microdevice treatment for prostate cancer is unique because it involves placing a small device directly into the prostate to test multiple therapies simultaneously, allowing for personalized treatment based on how the cancer responds to each option. This approach is different from traditional treatments that typically apply a single therapy to the entire prostate. ^{6 7 8 9 10}

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

NanoVelcro Chip for CTC enumeration in prostate cancer patients. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

An integrated microfluidic chip for immunomagnetic detection and isolation of rare prostate cancer cells from blood. [2016]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Phenotypic Profiling of Circulating Tumor Cells in Metastatic Prostate Cancer Patients Using Nanoparticle-Mediated Ranking. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Separation and dual detection of prostate cancer cells and protein biomarkers using a microchip device. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Implanted dosimeters identify radiation overdoses during IMRT for prostate cancer. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Quantitative assessment of PSMA PET response to therapy in castration-sensitive prostate cancer using an automated imaging platform for disease identification and measurement. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Incorporating PSMA-Targeting Theranostics Into Personalized Prostate Cancer Treatment: a Multidisciplinary Perspective. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Short-term freedom from disease progression after I-125 prostate implantation. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Prostate specific membrane antigen positron emission tomography for lesion-directed high-dose-rate brachytherapy dose escalation. [2022]