Pembrolizumab plus intensive androgen-blocking before prostatectomy for high-risk localized prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm Phase II trial gives pembrolizumab and enzalutamide before prostatectomy with extended pelvic lymph node dissection in men with high-risk localized prostate cancer. Participants receive pembrolizumab 200 mg IV every 3 weeks and enzalutamide 160 mg orally daily for a neoadjuvant period prior to radical prostatectomy. The primary endpoint is pathologic complete response (no detectable cancer in the prostatectomy specimen), and safety and clinical outcomes are also recorded. Eligible patients are adults with non-metastatic prostate adenocarcinoma who meet at least one high-risk criterion (Gleason ≥8, PSA >20 ng/mL, or clinical T3a) and have ECOG performance status 0–1.

Why it matters

Who can join: the full rules

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.

Where it's running

• VA Portland Healthcare System
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Mark Garzotto, MD — Portland VA Medical Center
• Study coordinator: Wesley Stoller, MA
• Email: stoller@ohsu.edu
• Phone: 5032208262

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hormone therapy with darolutamide and pembrolizumab before prostate removal, then pembrolizumab after surgery for high-risk prostate cancer

  This trial will test whether giving androgen-deprivation therapy plus darolutamide and pembrolizumab before prostate removal, followed by pembrolizumab after surgery, helps men with genomically defined high-risk localized prostate cancer.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07027124

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• Combining immunotherapy and radiation for high-risk prostate cancer

  This study is testing if combining an immunotherapy drug with radiation, and possibly adding another medication, can help men with high-risk prostate cancer do better than with standard treatment alone.

  Recruiting Phase 2 University of Kentucky · Lexington, Kentucky and 1 other locations · NCT05568550

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• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.