Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Recruiting
Phase 2
Interventional Study
Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 32 (estimated)
- Sponsor
- Mark Garzotto, MD · Federal
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About This Trial
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.
Trial Locations
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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.…
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