Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
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ClinicalTrials.gov Identifier: NCT03753243 |
Recruitment Status :
Recruiting
First Posted : November 26, 2018
Last Update Posted : April 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Drug: Pembrolizumab Drug: Enzalutamide | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
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. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer |
Actual Study Start Date : | December 3, 2018 |
Estimated Primary Completion Date : | September 3, 2022 |
Estimated Study Completion Date : | April 30, 2023 |

Arm | Intervention/treatment |
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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.
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Drug: Pembrolizumab
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Other Name: Keytruda Drug: Enzalutamide Patients will receive daily oral doses of study drug (enzalutamide 160 mg/day), which will be administered as four capsules/day to be taken at or near the same time each day.
Other Name: Xtandi |
- Pathologic Complete Response [ Time Frame: 4 months ]No cancer detected on pathology examination of prostatectomy specimen
- Treatment Related Adverse Events [ Time Frame: 4 months + 30 days ]Grade 3 or higher adverse event (AE) possibly related or related to any of three treatment drugs (pembrolizumab, enzalutamide, Gonadotropin-releasing hormone (GNRH) agonist) per CTCAE v4.03, evaluated up until 30 days after prostatectomy
- Immune -related Adverse Events [ Time Frame: 4 months + 30 days ]Grade 2 or higher immune related AE possibly related or related to any of three treatment drugs (pembrolizumab, enzalutamide, GNRH agonist) per CTCAE v4.03, evaluated up until 30 days after prostatectomy
- Biochemical Complete Response [ Time Frame: 4 months ]Prostate-Specific Antigen (PSA) < 0.1 ng/mL prior to prostatectomy
- Incidence of Surgical Complications [ Time Frame: 4 months ]Clavien-Dindo Classification of Surgical Complications compared to historical department incidence rates.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753243
Contact: Wesley Stoller, MA | 5032208262 ext 54931 | stoller@ohsu.edu | |
Contact: Mark Garzotto, MD | 5032208262 ext 51982 | mark.garzotto@va.gov |
United States, Oregon | |
VA Portland Healthcare System | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Wesley Stoller, MA 503-220-8262 ext 54931 stoller@ohsu.edu | |
Principal Investigator: Mark Garzotto, MD |
Principal Investigator: | Mark Garzotto, MD | Portland VA Medical Center |
Documents provided by Mark Garzotto, MD, Portland VA Medical Center:
Responsible Party: | Mark Garzotto, MD, Director of Urologic Oncology, Portland VA Medical Center |
ClinicalTrials.gov Identifier: | NCT03753243 |
Other Study ID Numbers: |
15235 |
First Posted: | November 26, 2018 Key Record Dates |
Last Update Posted: | April 20, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Neoadjuvant Programmed cell death protein 1 (PD-1) |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Prostatic Diseases Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents |