Actively Recruiting
Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer
Led by University of Wisconsin, Madison · Updated on 2026-01-28
60
Participants Needed
1
Research Sites
363 weeks
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The current protocol will examine the use of a plasmid DNA vaccine encoding AR, alone or with T-cell checkpoint blockade, to induce and/or augment therapeutic T-cells following androgen deprivation in patients with newly diagnosed prostate cancer scheduled to undergo prostatectomy. Patients without evidence of metastatic disease, with tissue remaining from a pre-treatment biopsy, and who are being considered for standard treatment by prostatectomy, will be invited to participate and will be on study for up to 15 months.
CONDITIONS
Official Title
Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the prostate
- Candidates for prostatectomy as per standard care
- High-risk for recurrent disease defined as either Gleason score 7 with PSA > 20 ng/mL or Gleason score > 7
- Life expectancy of at least 12 months
- ECOG performance status of 0 or 1
- Adequate blood counts and organ function within 4 weeks before treatment
- No known HIV 1 or 2, HTLV-1, or active Hepatitis B or C infection
- Adequate prostate tissue available from prior biopsy for research
- Willing to undergo large-volume blood draws for research
- Willing to use barrier contraception if sexually active during treatment
- Able to provide informed consent
- Able to comply with study procedures and remain supine for 120 minutes during imaging
You will not qualify if you...
- Small cell or other variant prostate cancer histology
- Prior prostate cancer treatment including hormone therapy, orchiectomy, antiandrogens, ketoconazole, abiraterone, or enzalutamide
- Prior radiation therapy to the prostate
- Receiving other investigational or anticancer therapies except study androgen deprivation therapy
- Use of systemic corticosteroids over 10 mg prednisone equivalent within 3 months
- Use of PC-SPES, certain herbal supplements, megestrol, ketoconazole, 5-alpha-reductase inhibitors started within 28 days prior to registration, diethylstilbesterol, or other hormonal agents for cancer treatment
- Major surgery within 4 weeks before registration
- Active cardiac disease like angina, heart failure, or recent heart attack within 6 months
- Psychological or social conditions preventing protocol compliance
- History of splenectomy
- Other active malignancies except certain treated skin or bladder cancers
- Any medical condition or intervention compromising safety or adherence
- Concurrent enrollment in other investigational treatment studies with recent dosing
- Live vaccine within 14 days before first study treatment
- History of life-threatening or active autoimmune disease needing systemic treatment in last 2 years
- History or current pneumonitis requiring corticosteroids
- History of allergic reaction to tetanus vaccine
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
C
Cancer Connect
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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