Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer

NCT04399876 | Enrolling By Invitation Phase 1 DMC FDA Drug

• 2 other identifiers: 19-599R01CA232174
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer; Radical Prostatectomy

Keywords

Prostate Cancer; Radical Prostatectomy

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events as defined in the CTCAE v4.0

  Safety of microdevice placement and removal based on assessment of adverse events

  From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.

• Number of Participants with successful surgical Placement and retrieval of Microdevice

  * Feasibility of microdevice placement based on the ability in the Surgical Cohort to percutaneously place and surgically retrieve the device with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation. * In the Surgical Cohort, if not more than 1 IMD per patient fails to be percutaneously placed and surgically retrieved with sufficient tissue of sufficient quality for downstream histopathology analysis and interpretation, we would consider this procedure to be a success. If at least 23/30 Surgical Cohort patients have successful procedures, as previously defined, we would consider this approach feasible. The 90% CI for 23 out of 30 successes is (60.6%, 88.5%) and thus excluding a 60% success rate which is considered as too low.

  48 Hours

Secondary Outcomes (4)

• Local intratumor response

  48 Hours

• Intratumor heterogeneity in drug response

  48 Hours

• Biomarkers of drug response

  48 Hours

• Genetic features of the tumor tissue

  48 Hours

Study Arms (2)

Surgery Cohort

EXPERIMENTAL

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

Combination Product: Microdevice

Ex-Vivo Cohort

EXPERIMENTAL

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

Combination Product: Microdevice

Interventions

Microdevice COMBINATION_PRODUCT

Surgery Cohort: Placement of 1-6 microdevices: Drugs chosen have all been FDA approved for the treatment of cancer (so therefore safe) and there are phase 2 or 3 data that the drug has efficacy in prostate cancer. Agents of interest included Abiraterone, Enzalutamide, Pembrolizumab, Ipilimumab, Carboplatin, Docetaxel, and Olaparib as well as combinations Ex vivo Cohort: Placement of multiple microdevices with miniature drug reservoirs but no drug is loaded into the removed prostate

Ex-Vivo Cohort; Surgery Cohort

Eligibility Criteria

• Age: 22 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have the ability to understand and the willingness to sign a written informed consent document.
• Planned radical prostatectomy for prostate cancer.
• Participants must be 22 years of age or older.

You may not qualify if:

• Eligibility Criteria: Surgical Cohort
• Participants must have the ability to understand and the willingness to sign a written informed consent document.
• Patients must have the ability to understand and the willingness to sign a written informed consent document at the study site when both the investigator and participant are at the same location, or remotely (e.g., at the participant's home or another convenient venue) where the participant reviews the consent document with the Licensed Physician Investigator over secure Zoom. The electronic consent system, Adobe, ensures the participant electronically signing the informed consent is the subject who will be participating in the research study.
• Participants must present with prostate cancer falling into an intermediate or high risk category to include features: Gleason score 3+4 or higher, greater than 3 biopsy cores positive and ≥50% of 1 core positive for carcinoma, and an MRI-visible lesion concerning for PCa in the region of the positive biopsy.
• Participants must be 22 years of age or older.
• Participants must be evaluated by a urologic oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease.
• Participants must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating surgeon.
• Participants must have undergone multi-parametric prostate MRI that both assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care. Abnormal imaging will be correlated with the biopsy findings to maximize the likelihood of the device being put in the lesion. If the images are not adequate, the MRI scan will be repeated at BWH/DFCI, again as part of standard-of-care management.
• The participant's case must be reviewed by representatives of urologic oncology and interventional radiology to assess the following factors:
• Participant is clinically stable to undergo biopsy procedure(s) and surgical procedures.
• Participant has sufficient volume of disease as shown by MRI to allow implantation of the microdevice.
• A lesion can be selected where the microdevice is to be implanted that is a) amenable to percutaneous placement, and b) amenable to removal at the time of primary surgery
• Participants must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.
• For men: agreement to refrain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for 28 days after the last dose of ipatasertib.
• 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 situations that would limit the safety of a biopsy and/or surgery.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Stone BV, Dominas CA, Bhagavatula SK, Ahn SW, Tatarova Z, Jakubik J, Matthew D, Mossanen M, Furtado D, Tuncali K, Hirsch MS, Hata N, Tempany C, Jonas O, Kibel AS. Novel Intraprostatic Magnetic Resonance-Guided Implantation of Multidrug-Eluting Microdevice for Testing of Systemic Therapy Agents In Situ: Proof of Concept in Intermediate-Risk and High-Risk Prostate Cancer. J Urol. 2025 Feb;213(2):173-182. doi: 10.1097/JU.0000000000004269. Epub 2024 Sep 30.

  PMID: 39348711 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Adam S Kibel, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: June 22, 2020
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)