Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Recruiting · NCT03753243 · Interventional (participants receive a specific treatment) · Lead sponsor: Mark Garzotto, MD
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Where it is running
1 location listed across 1 US state.
- VA Portland Healthcare System - Portland, Oregon, United States