NCT03753243 Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
| NCT ID | NCT03753243 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mark Garzotto, MD |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2018-12-03 |
| Primary Completion | 2022-09-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2018-12-03 with a primary completion date of 2022-09-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Mark Garzotto, MD
PRINCIPAL INVESTIGATOR
Portland VA Medical Center
Frequently Asked Questions
Who can join the NCT03753243 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03753243 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03753243 currently recruiting?
Yes, NCT03753243 is actively recruiting participants. Contact the research team at stoller@ohsu.edu for enrollment information.
Where is the NCT03753243 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT03753243 clinical trial?
NCT03753243 is sponsored by Mark Garzotto, MD. The principal investigator is Mark Garzotto, MD at Portland VA Medical Center. The trial plans to enroll 32 participants.
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