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Immunotherapy
ADXS-504 Immunotherapy for Prostate Cancer
Phase 1
Recruiting
Led By Mark N. Stein, MD
Research Sponsored by Mark Stein
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Histologically documented prostatic adenocarcinoma confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective.
Who is the study for?
Men over 18 with recurrent prostate cancer after primary therapy like surgery or radiation, not on active treatment for other cancers. They must have a stable performance status, adequate organ function, and rising PSA levels according to specific criteria. Participants need to provide consent and health information release, agree to contraceptive guidance if applicable, and cannot have brain metastases or severe autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing ADXS-504 immunotherapy in men with recurring prostate cancer. It aims to find the safest dose that patients can tolerate (MTD) or recommend for future studies (RP2D), measure immune response effects of the drug, observe changes in PSA levels, and assess time until PSA levels rise again.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects of immunotherapies like ADXS-504 may include flu-like symptoms such as fever and chills; fatigue; pain at injection site; allergic reactions; auto-immune responses where the body attacks its own cells; digestive issues; skin rash.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My prostate cancer was confirmed by a biopsy or surgery.
Select...
I am mostly active and can care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1. Incidence of adverse events (AEs), graded by CTCAE v 5.0 (Common Terminology Criteria for Adverse Events)
Side effects data
From 2012 Phase 2 & 3 trial • 4 Patients • NCT0009049375%
DVT
75%
Staphyloccocal infections
25%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY
Trial Design
1Treatment groups
Experimental Treatment
Group I: ADXS-504 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Subjects with Biochemically Recurrent Prostate Cancer will receive ADXS-504 with dose escalation schema.
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Who is running the clinical trial?
Mark SteinLead Sponsor
3 Previous Clinical Trials
128 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer
Mark N. Stein, MDPrincipal InvestigatorColumbia University
4 Previous Clinical Trials
141 Total Patients Enrolled
1 Trials studying Prostate Cancer
60 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had initial treatment for prostate cancer and any follow-up treatment was over 6 months ago.I cannot take certain medications due to adverse reactions.I am 18 years old or older.I am a man and will use birth control during and for 4 months after treatment.I have a history of HIV or active hepatitis B or C.My PSA levels are increasing after my initial prostate cancer treatment.I have cancer that has spread to my brain.My prostate cancer was confirmed by a biopsy or surgery.I have received a transplant from a donor.I do not have any serious or uncontrolled health conditions.I can provide a sample from a previous biopsy for further testing.I am mostly active and can care for myself.My scans show cancer spread that can be measured or seen, done within the last 8 weeks.My testosterone level is at least 150 ng/dL.I have another cancer type that could spread and it's been in remission for less than 3 years.I have used treatments that affect my PSA levels.I have not had major surgery or a significant injury in the last 6 weeks.My liver, kidneys, and bone marrow are functioning well.I am currently on medication for an infection.I have been treated for an autoimmune disease in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: ADXS-504 Monotherapy Dose Escalation
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.
To what extent can patients be put at risk when using ADXS-504?
"Our team at Power judged the safety of ADXS-504 to be a 1 due its status as a Phase 1 trial, implying that there is only limited clinical evidence in support of both efficacy and safety."
Answered by AI
Are there still openings for enrollees in this research program?
"Based on the information found on clinicaltrials.gov, this study is in its recruitment phase and has been updated since it was first published on August 12th 2021. The most recent modification occurred on October 10th 2021."
Answered by AI
How many individuals are taking part in this research experiment?
"Yes, the evidence from clinicaltrials.gov affirms that this medical trial is currently in recruitment mode. Initially posted on August 12th 2021 and recently amended on October 10th 2021, it aims to enroll 21 patients at a single location."
Answered by AI
Is the age ceiling for this research higher than 65 years?
"This research is seeking volunteers that are aged 18 to 99."
Answered by AI
Would I qualify to partake in this investigation?
"This medical trial is searching for 21 individuals, aged between 18 and 99, that have experienced a relapse. In addition to this selection criteria, applicants must possess an ECOG Performance Status of 0-1 within the 4 weeks before registration; they need to have had primary therapy for prostate cancer in the past; and if salvage external beam radiation or cryotherapy took place following their first treatment it must have been over 6 months prior to randomization."
Answered by AI
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