Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Prostate Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Enrolling By Invitation
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Number of participants with adverse events as defined in the CTCAE v4.0
Study Overview
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
Detailed Description
This research study is assessing the feasibility and safety of implanting and retrieving a 'microdevice' that releases up to 20 drugs directly within the prostate cancer lesion as a possible tool to evaluate the effectiveness of several approved cancer drugs against prostate cancer.
Participants will be identified with confirmed prostate cancer whose treatment plan includes surgery as a component of standard-of-care treatment.
The name of the study intervention involved in this study is:
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Implantation of a MR-guided microdevice .
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It is expected that about 35 people will take part in this research study; 5 in the Ex Vivo Cohort and 30 in Surgery Cohort.
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Ex Vivo Cohort will undergo placement of microdevice in the prostate after its surgical removal.
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Surgery Cohort will undergo percutaneous placement of several microdevices in a selected tumor prior to surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligibility Criteria: Ex Vivo Cohort
- •Inclusion Criteria
- •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.
Exclusion Criteria
- •- Unwillingness to sign informed consent.
- •Eligibility Criteria: Surgical Cohort
- •Inclusion Criteria
- •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.
- •Exclusion Criteria
- •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.
- •Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures.
Arms & Interventions
Surgery Cohort
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
Intervention: Microdevice (Combination Product)
Ex-Vivo Cohort
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
Intervention: Microdevice (Combination Product)
Outcomes
Primary Outcomes
Number of participants with adverse events as defined in the CTCAE v4.0
Time Frame: From the time of arrival to interventional radiology for microdevice placement up to 6 weeks.
Safety of microdevice placement and removal based on assessment of adverse events
Number of Participants with successful surgical Placement and retrieval of Microdevice
Time Frame: 48 Hours
* 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.
Secondary Outcomes
- Intratumor heterogeneity in drug response(48 Hours)
- Local intratumor response(48 Hours)
- Genetic features of the tumor tissue(48 Hours)
- Biomarkers of drug response(48 Hours)
Investigators
Oliver Jonas
Physician
Brigham and Women's Hospital