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Pembrolizumab and Enzalutamide for High-Risk Prostate Cancer

This study is looking at how well a combination of two drugs, pembrolizumab and enzalutamide, works before surgery for men with high-risk localized prostate cancer. Pembrolizumab is given through an IV every three weeks, and enzalutamide is taken daily by mouth. The main goal is to see if this treatment can completely get rid of cancer cells in the prostate before surgery. To join, you must be at least 18 years old and have high-risk localized prostate cancer. The study plans to enroll 32 participants, but its current recruitment status is unclear.

Study design
This is a single-arm, open-label Phase II study, meaning all 32 participants will receive the same treatment and both you and the study team will know which drugs you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, pathologic complete response, is measured at 4 months, but the full duration of follow-up is not specified.

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NCT03753243

Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mark Garzotto, MD
~32 participants
Updated 2022-04-20 on ClinicalTrials.gov
What's tested:PembrolizumabEnzalutamide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic Complete Response
Measured over 4 months

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Mark Garzotto, MD · PRINCIPAL_INVESTIGATOR · Portland VA Medical Center

Who to contact

Wesley Stoller, MA
[email protected]
5032208262 · ext. 54931
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Be willing and able to provide written informed consent/assent for the trial.
Capability to understand and comply with the protocol and signed informed consent document.
Be ≥ 18 years of age on day of signing informed consent.
Have measurable disease based on RECIST 1.1.
Histologically confirmed, non-metastatic adenocarcinoma of the prostate
Prostatectomy with extended lymph node dissection planned as primary therapy
10 year or longer life expectancy based on other co-morbidities
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Any one of the following three high risk features:
Gleason grade \> 8-10
PSA \> 20 ng/ml
Clinical stage T3a (resectable)
No evidence of metastases .
No other diagnosis of malignancy (with exception of non-melanoma skin cancer or a malignancy diagnosed ≥5 years ago).
Male subjects of childbearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through the time of surgery. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Demonstrate adequate organ function, all screening labs should be performed within 30 days of treatment initiation.

What this trial measures

  • Pathologic Complete Response4 months

    No cancer detected on pathology examination of prostatectomy specimen