← Back to Search

Radical prostatectomy for Prostate Cancer

Phase 2

Waitlist Available

Led By Russell K Pachynski, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of follow-up (approximately 10 weeks after start of treatment)

Awards & highlights

Study Summary

This trial is testing whether a vaccine given before surgery can improve long-term outcomes for patients with localized prostate cancer who are undergoing radical prostatectomy.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of follow-up (approximately 10 weeks after start of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of follow-up (approximately 10 weeks after start of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of follow-up (approximately 10 weeks after start of treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

B cell infiltration (Phase 2)

Dose Limiting Toxicities (Safety Run-In)

T cell infiltration (Phase 2)

Secondary outcome measures

Change in frequency of circulating B cells (Phase 2)

Change in frequency of circulating T cells (Phase 2)

Cytotoxic effect (Phase 2)

+5 more

Side effects data

From 2010 Phase 3 trial • 731 Patients • NCT00007644

47%

Death

100%

80%

60%

40%

20%

Study treatment Arm

Radical Prostatectomy

Watchful Waiting

Trial Design

2Treatment groups

Experimental Treatment

Group I: Safety Run-In and Phase II: IbrutinibExperimental Treatment2 Interventions

Ibrutinib 840 mg by mouth once daily for 4 weeks. Radical prostatectomy will be performed at least 7 days but not more than 12 days following the last scheduled dose of ibrutinib

Group II: Phase I: IbrutinibExperimental Treatment2 Interventions

Ibrutinib 840 mg by mouth once daily for 2 weeks. Radical prostatectomy will be performed at least 7 days but not more than 12 days following the last scheduled dose of ibrutinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radical prostatectomy

2016

Completed Phase 3

~1700

Ibrutinib

2014

Completed Phase 3

~1880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,682 Total Patients Enrolled

17 Trials studying Prostate Cancer

4,244 Patients Enrolled for Prostate Cancer

Pharmacyclics LLC.Industry Sponsor

113 Previous Clinical Trials

13,793 Total Patients Enrolled

Russell K Pachynski, M.D.Principal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still feasible for prospective participants to join this trial?

"The latest information published on clinicaltrials.gov informs us that this medical experiment is still open for enrolment; first advertised in July 2016 and recently updated in August 2022."

Answered by AI

What objectives are being pursued in this trial's research?

"The primary goal of this trial is to assess the Dose Limiting Toxicities (DLT) which will be carefully monitored over a period of 10 weeks. Secondary objectives include assessing changes in T cell infiltration through Immunohistochemistry, and observing dose-dependent alterations in circulating B cells/T cells with Flow cytometry techniques."

Answered by AI

How many individuals are eligible to participate in this investigation?

"Affirmative. Evidence on clinicaltrials.gov corroborates that this medicinal experiment, which was initially published on July 1st 2016, is now actively seeking participants. 27 individuals must be enrolled from a single location."

Answered by AI

What potential risks may patients encounter when undergoing Radical prostatectomy?

"There exists some evidence of Radical prostatectomy's safety, leading to it being scored 2 on our scale. Unfortunately, no clinical data testifies its efficacy at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer

2016. "Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02643667.