Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Purpose
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.
Condition
- Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
Criteria
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- single arm, single-stage open label Phase II of neoadjuvant immune-hormonal therapy in high-risk Localized prostate cancer.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention |
Treatment will be planned for a total of 14 to 16 weeks. Pembrolizumab will be administered every 3 weeks via IV infusion with a dose of 200 mg per infusion. Enzalutamide will be given orally and dispensed to the patient on the date of their first infusion. The dosage of Enzalutamide will be 160 mg, administered once daily for approx. 16 weeks. GNRH agonist therapy will be administered as a standard of care therapy and will follow a standard dosage to maintain castrate levels. |
|
Recruiting Locations
Portland, Oregon 97239
More Details
- Status
- Recruiting
- Sponsor
- Mark Garzotto, MD
Detailed Description
The investigators propose to study the effects of pembrolizumab combined with intensive androgen receptor (AR) targeting prior to prostatectomy with extended pelvic lymph node dissection in subjects with high-risk localized prostate cancer (HRLPC). Trial Design- single arm, single-stage, open label Phase II of neoadjuvant immune-hormonal therapy in high-risk localized prostate cancer. Objectives To evaluate efficacy and safety of pembrolizumab combined with intensive AR targeting prior to prostatectomy in subjects with high-risk localized prostate cancer (HRLPC). Primary Endpoint Pathologic complete response (pCR) defined as absence of detectable malignant cells in the prostatectomy specimen evaluated by standard histologic techniques.