Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer (NCT05077098) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of ADXS-504 Immunotherapy for Recurrent Prostate Cancer
United States8 participantsStarted 2021-08-12
Plain-language summary
Primary Objective:
\- To evaluate the safety and tolerability of ADXS-504 and to determine the MTD (maximum tolerated dose) or RP2D (recommended phase two dose)
Secondary Objectives:
* To characterize the immunological activity of ADXS-504, administered as; and to characterize the genomic profiles of study subjects
* To evaluate the effects of ADXS-504 on change in PSA
* To evaluate time to PSA progression
Who can participate
Age range
18 Years – 99 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically documented prostatic adenocarcinoma confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen.
. Age ≥18 years
. Previously undergone primary therapy for prostate cancer. Salvage XRT or cryotherapy following primary therapy ≥ 6 months prior to randomization is allowed.
. A rising prostate specific antigen (PSA) defined as the following
. PSA ≥0.3 in addition to prostate-specific antigen doubling time (PSADT)≥4 months. PSADT will be determined from all non-zero PSA values within 12 months prior to registration. To calculate PSADT, there must be at least THREE PSA values, with at least 3 weeks between each measurement. The PSADT will be computed from the formula: PSADT = (loge2)/k, with k being the estimated slope of the logarithm of PSA over time.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1. Incidence of adverse events (AEs), graded by CTCAE v 5.0 (Common Terminology Criteria for Adverse Events)
. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, or Karnofsky score ≥ 70%
. Testosterone ≥ 150 ng/dL ≤ 28 days of prior to registration
. Adequate bone marrow, hepatic, and renal function.
Exclusion criteria
. Subject has evidence of measurable or evaluable metastatic disease on bone or computed tomography (CT) or positron emission tomography(PET) scans performed ≤8 weeks of registration (patients with PET scan findings consistent with metastasis but who have normal conventional imaging by CT/MRI/Bone scan using standard radiographic criteria ARE eligible)
. Subject has known brain metastasis. Subjects with neurological symptoms must undergo a CT scan/magnetic resonance imaging (MRI) of the brain to exclude brain metastasis;
. Subject has an active autoimmune disease requiring systemic treatment within the past 3 months, a documented history of clinically severe autoimmune disease, or a disorder that requires systemic corticosteroids or immunosuppressive agents. Subjects with vitiligo, psoriasis, alopecia or resolved childhood asthma/atopy not requiring systemic treatment would be an exception to this rule. Subjects with hypothyroidism who are stable on hormone replacement (\>10 mg daily prednisone equivalent) or Sjögren's syndrome will not be excluded from the study;
. Subject has had an allogeneic tissue/solid organ transplant;
. Subject has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies);
. Subject has a known active hepatitis B (e.g., hepatitis B virus surface antigen reactive) or hepatitis C infection (e.g., hepatitis C virus RNA \[qualitative\] is detected);
. Subject has an active infection requiring systemic therapy or is dependent on or currently receiving antibiotics that cannot be discontinued before dosing. (Note: Subjects who discontinue an antibiotic prior to dosing must wait at least 5 half-lives after the last dose of antibiotic before receiving any study treatment);
. Subject has an implanted medical device that poses a high risk for bacterial colonization and/or that cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screws, metal plates, bone grafts, or other exogenous implants). NOTE: More common devices and prosthetics that include arterial and venous stents, dental and breast implants and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device or implant;