Actively Recruiting
Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Led by Mark Garzotto, MD · Updated on 2022-04-20
32
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
Sponsors
M
Mark Garzotto, MD
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pembrolizumab will be administered at a dose of 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Enzalutamide will be administered at dose of 160 mg orally every day. All patients will be required to have at least one high-risk criteria.
CONDITIONS
Official Title
Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial
- Able to understand and follow the study protocol and consent document
- Male, 18 years of age or older at time of consent
- Measurable disease based on RECIST 1.1 criteria
- Histologically confirmed non-metastatic adenocarcinoma of the prostate
- Planned prostatectomy with extended pelvic lymph node dissection as primary therapy
- Life expectancy of 10 years or longer based on other health conditions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Presence of at least one high-risk feature: Gleason grade > 8-10, PSA > 20 ng/ml, or clinical stage T3a (resectable)
- No evidence of metastases
- No other active malignancy except non-melanoma skin cancer or malignancy diagnosed 5 or more years ago
- Male subjects of childbearing potential must agree to use adequate contraception from first dose through surgery
- Demonstrate adequate organ function with screening labs performed within 30 days before starting treatment
You will not qualify if you...
- Evidence of metastatic prostate cancer
- Presence of another active malignancy except non-melanoma skin cancer or malignancy diagnosed less than 5 years ago
- Performance status worse than ECOG 1
- Inability or unwillingness to comply with study procedures or provide consent
- Female or non-male subjects (gender restriction)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VA Portland Healthcare System
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
W
Wesley Stoller, MA
CONTACT
M
Mark Garzotto, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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