Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/6/2018 |
| Start Date: | December 3, 2018 |
| End Date: | April 30, 2023 |
| Contact: | Wesley Stoller, MA |
| Email: | stoller@ohsu.edu |
| Phone: | 5032208262 |
Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
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.
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.
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.
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.
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.
We found this trial at
1
site
3710 Southwest US Veterans Hospital Road
Portland, Oregon 97239
Portland, Oregon 97239
Principal Investigator: Mark Garzotto, MD
Phone: 503-220-8262
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