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Monoclonal Antibodies
Atezolizumab-Based Combination Therapy for Prostate Cancer
Phase 2
Recruiting
Led By Lawrence Fong, MD
Research Sponsored by Lawrence Fong
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing a combination of immunotherapy and two other drugs to see if it is effective in treating localized prostate cancer.
Who is the study for?
Men with localized prostate cancer who haven't had previous treatments for it, are over 18, in good health with proper organ and marrow function, and eligible for surgery. They must have high-risk disease for certain parts of the trial, a testosterone level above 150 ng/dL, agree to use contraception and not donate sperm.Check my eligibility
What is being tested?
The effectiveness of Atezolizumab alone or combined with Etrumadenant or Tocilizumab is being tested before surgical removal of the prostate. The study aims to see if these treatments can help the immune system fight cancer better than current methods.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells (autoimmunity), infusion-related reactions like fever or chills, fatigue, hormonal imbalances due to anti-androgen therapy, and potential blood disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am approved for and agree to undergo major prostate surgery.
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I am fully active or can carry out light work.
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My organs and bone marrow are working well.
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My prostate cancer diagnosis was confirmed through a tissue examination.
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I have not had any treatment for prostate cancer.
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My condition is considered high-risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects who demonstrate a positive response to neoadjuvant atezolizumab and atezolizumab-based combination therapy for each Cohort of the study
Secondary outcome measures
Number of treatment-related of adverse events
Prostate specific antigen (PSA) response
Rate of Minimal residual disease (MRD)
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C (atezolizumab, tocilizumab)Experimental Treatment2 Interventions
Patients will receive one (1) cycle of neoadjuvant atezolizumab and one (1) cycle of tocilizumab, 6mg/kg will be administered IV on day 1 of a 14 day IV prior to RP; atezolizumab will be administered in an identical fashion as Cohort A. RP will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP.
Group II: Cohort B (atezolizumab, etrumadenant)Experimental Treatment2 Interventions
Patients will receive one (1) cycle of atezolizumab, 1200mg intravenously (IV) over 30-60 minutes on day 1 of a 14 day cycle and etrumadenant will be taken at a dose of 150mg PO, once daily, until 48 hours prior to RP, for at least 12 days. Radical Prostatectomy (RP) will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP.
Group III: Cohort A (atezolizumab)Experimental Treatment1 Intervention
Patients receive one (1) cycle of atezolizumab, 1200mg intravenously (IV) over 30-60 minutes on day 1 of a 14 day cycle. Radical Prostatectomy (RP) will occur 21 days (+/- 7 days) following the final dose of atezolizumab. No further study therapy will be administered following RP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840
Etrumadenant
2018
Completed Phase 1
~130
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Lawrence FongLead Sponsor
5 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Prostate Cancer
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,621 Total Patients Enrolled
16 Trials studying Prostate Cancer
6,142 Patients Enrolled for Prostate Cancer
Lawrence Fong, MDPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
10 Previous Clinical Trials
232 Total Patients Enrolled
3 Trials studying Prostate Cancer
74 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any immune-boosting drugs in the last 4 weeks.This does not apply to me as it is an exclusion criterion.You need to have a tumor sample that is suitable for the study analysis, as determined by the study leader.I have previously been treated with specific immune therapies.You are pregnant or currently breastfeeding.I have had a previous transplant of stem cells or an organ.I have a condition that weakens my immune system.I have a serious heart condition.I need oxygen or steroids at home for my COPD.I have no health issues that prevent me from taking new medications.I am 18 years old or older.I have been treated with tocilizumab before.I have been treated with chemicals or radiation targeting my immune system.I have an active hepatitis B or C infection.I have not had a severe infection in the last 4 weeks.I have been treated with therapies that reduce cell counts before.I have had radiation therapy for prostate cancer.I need oral steroids for my asthma.I do not have nerve issues that could affect pain assessment.I am approved for and agree to undergo major prostate surgery.I have a history of specific lung conditions not caused by known factors.I am fully active or can carry out light work.My organs and bone marrow are working well.I have been on a stable blood thinner regimen for more than 3 months.I have had cancer before, but it was a specific type.I haven't had treatments like IVIG, plasmapheresis, or Prosorba in the last 6 months.My doctor has decided surgery is not an option for my prostate cancer.I have not received a live vaccine in the last 4 weeks.I have had a serious infection recently.My prostate cancer diagnosis was confirmed through a tissue examination.You are allergic to any of the study drugs or their ingredients.My scans show cancer has spread to other parts of my body.You have or have had a condition that affects your immune system.I have had treatment for prostate cancer.I do not have any uncontrolled serious illness affecting my organs.I haven't taken any immune-weakening drugs in the last 2 weeks.I have not had any treatment for prostate cancer.I have not had major surgery in the last 4 weeks.I have difficulty with IV access in my arms.My condition is considered high-risk.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A (atezolizumab)
- Group 2: Cohort B (atezolizumab, etrumadenant)
- Group 3: Cohort C (atezolizumab, tocilizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any additional participants needed for this clinical experiment?
"Affirmative, clinicaltrials.gov reveals that this medical trial is recruiting participants since its initial posting on October 30th 2019 and up to the most recent modification on October 8th 2022. It necessitates 68 patients from 3 sites for completion of the study."
Answered by AI
What medical conditions is Tocilizumab usually prescribed to treat?
"Tocilizumab is widely used to manage small cell lung cancer (SCLC); however, it has also proven successful in treating systemic juvenile idiopathic arthritis (sjia), cytokine release syndrome caused by CAR-T Cell Therapy and malignant neoplasms."
Answered by AI
Is this experiment the initial venture of its variety?
"At present, there are 410 ongoing clinical trials for Tocilizumab across 81 nations and 1798 cities. Hoffmann-La Roche was the first to conduct a trial with 720 participants back in 2008; since then, 304 have been concluded. This initial study made it through Phase 2 drug approval stage."
Answered by AI
How many participants have signed up for this experiment so far?
"Correct. According to clinicaltrials.gov, this medical study is still recruiting patients; it was initially posted on October 30th 2019 and recently updated on October 8th 2022. A total of 68 participants are needed from the three designated sites."
Answered by AI
Are there any additional investigations pertaining to Tocilizumab?
"Presently, there are 410 research studies examining Tocilizumab. Out of those 410 investigations, 78 are in Phase 3 and located mostly around Harvey, Illinois but with a total of 19515 sites running trials for this drug worldwide."
Answered by AI
Is Tocilizumab considered a safe option for individuals?
"As this a Phase 2 trial, it is reasonable to assume that there has been some clinical data collected regarding the safety of Tocilizumab and thus it received a score of 2."
Answered by AI
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