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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological documented high-risk localized prostate cancer defined by clinical stage >=T3 or Gleason score ≥8
Normal organ function defined by: Hgb > 10 mg/dl (may be transfused or on erythropoietin), Platelets > 100,000/l, Absolute neutrophil count > 1500/l, Bilirubin < 1.5 mg/dl, AST and ALT < 1.5X upper limit of normal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test different doses of TNFerade in combination with radiation to see which is the most effective at treating prostate cancer while also having the least side effects.
Who is the study for?
Men with high-risk localized prostate cancer, without distant metastases but possibly with pelvic lymph node involvement. They must have a hemoglobin level above 10 mg/dl, platelets over 100,000/l, and normal liver function. Participants should not have had chemotherapy recently or be unable to undergo daily radiation therapy due to other health issues.Check my eligibility
What is being tested?
The trial is testing TNFerade™ Biologic combined with radiation against prostate cancer. TNFerade is an experimental gene transfer therapy designed to enhance the effectiveness of radiation treatment by being injected directly into the tumor.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information. However, as a gene transfer therapy used alongside radiation, possible side effects could include local reactions at injection sites, fatigue from radiation, and typical risks associated with gene therapies such as immune responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is aggressive, with a high Gleason score or advanced stage.
Select...
My blood counts and liver function tests are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
1Treatment groups
Experimental Treatment
Group I: SingleExperimental Treatment1 Intervention
TNFerade™ Biologic + Radiation
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,568 Total Patients Enrolled
29 Trials studying Prostate Cancer
6,957 Patients Enrolled for Prostate Cancer
GenVecLead Sponsor
8 Previous Clinical Trials
129 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an active infection.I agree to use barrier contraception for 8 weeks and any birth control for a year after the last TNFerade™ dose.I have had blood clots or am known to have clotting disorders.I am HIV-positive and on combination anti-retroviral therapy.I do not have any major health or mental conditions that would stop me from following the study's requirements.My prostate cancer is aggressive, with a high Gleason score or advanced stage.I cannot have prostate radiotherapy due to past pelvic radiation or other health issues.My cancer has not spread to distant parts of my body, but it may be in my pelvic lymph nodes.I haven't had major surgery in the last month.I haven't taken chemotherapy or experimental drugs in the last 4 weeks.I have been on oral steroids higher than 10 mg/day for over 6 months.I am currently on blood thinners other than low-dose aspirin.I have not had a stroke, heart attack, or any vascular procedure for blocked arteries in the last 6 months.My blood counts and liver function tests are within normal ranges.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Single
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.
What safety concerns should individuals be aware of prior to using TNFerade™ Biologic?
"As this trial is in its initial stages, there is limited evidence on the safety and efficacy of TNFerade™ Biologic. Therefore, our team at Power has rated it a 1 on their scale."
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